clinical research associate job duties

Clinical Research Associate: Roles & Responsibilities

Introduction

Clinical research plays a pivotal role in advancing medical knowledge and patient care. At the heart of this process are Clinical Research Associates (CRAs), professionals who ensure the efficacy and safety of clinical trials. As the pharmaceutical and biotechnology industries expand, so does the demand for skilled CRAs. This blog aims to demystify the roles and responsibilities of a CRA and highlight the significance of this career in the realm of clinical research.

A Clinical Research Associate is a professional who monitors the administration and progress of a clinical trial (a research study that tests how well new medical approaches work in people). Typically, CRAs hold a degree in pharmacy, life sciences, nursing, or a related field, combined with substantial knowledge of clinical research protocols. They are the linchpins in the development of drugs, biologics, and medical devices, bridging the gap between the clinical trial process and regulatory compliance.

Key Responsibilities of a Clinical Research Associate

1. site selection and preparation.

CRAs are involved in selecting suitable sites for clinical trials, and assessing the capabilities of a site to conduct the trial. This involves evaluating the staff’s qualifications, the facility’s equipment, and the site’s patient population. They also play a key role in preparing the site for the study, ensuring that each site has the necessary materials and training to conduct the trial according to protocol.

2. Protocol Development and Implementation

CRAs contribute to developing the clinical trial protocol, a document that outlines the objectives, design, methodology, statistical considerations, and organization of a trial. They ensure that the trial is implemented as per the protocol and that any deviations are documented and justified.

3. Subject Recruitment and Consent

A crucial aspect of a CRA’s role is facilitating the recruitment of subjects for the trial. They ensure that potential subjects are properly informed about the trial and that informed consent is obtained in accordance with regulatory requirements.

4. Monitoring Clinical Trials

CRAs regularly visit trial sites to monitor the progress of the trial. They verify that the clinical trial data recorded by investigators is accurate and that the trial is being conducted in compliance with the protocol, Good Clinical Practice (GCP), and regulatory requirements.

5. Ensuring Compliance

CRAs ensure that clinical trials comply with regulatory standards and ethical guidelines. They are responsible for understanding and keeping up to date with regulations and guidelines, such as those set by the FDA or EMA.

6. Data Management and Reporting

Managing and overseeing the data collected during clinical trials is another key responsibility. CRAs review data for accuracy and completeness and assist in preparing reports on the trial’s findings.

Challenges Faced by Clinical Research Associates

CRAs often face challenges such as managing responsibilities across multiple trial sites, ensuring data integrity, and adapting to constantly changing regulatory environments. Problem-solving skills, adaptability, and a keen eye for detail are essential traits for success in this role.

The Future of Clinical Research Associates

The role of a CRA is evolving with advancements in technology and changes in the regulatory landscape. CRAs are increasingly involved in virtual or remote monitoring of trials, using digital tools to manage and oversee trial progress. As the field grows, so do the career paths and advancement opportunities for CRAs.

Clinical Research Associates play a critical role in the success of clinical trials. They ensure that trials are conducted ethically, efficiently, and in compliance with regulatory standards. The role of a CRA is not only challenging and demanding but also highly rewarding, contributing significantly to the advancement of medical research and patient care.

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Clinical Research Associate Job Description [Updated for 2024]

In the modern healthcare industry, the role of Clinical Research Associates is indispensable.

As the healthcare landscape progresses, the demand for skilled professionals who can execute, manage, and ensure the quality of clinical research escalates.

Let’s delve deeper: What is truly expected from a Clinical Research Associate?

Whether you are:

• A job seeker wanting to understand the core aspects of this role,
• A hiring manager outlining the perfect candidate,
• Or simply fascinated by the intricacies of clinical research,

You’ve found the right place.

Today, we present a customizable Clinical Research Associate job description template, designed for effortless posting on job boards or career sites.

Let’s dive right in.

Clinical Research Associate Duties and Responsibilities

Clinical Research Associates play a crucial role in clinical trials and research studies.

They are involved in every stage of the process, from planning to data collection, analysis, and reporting.

They often work in a team with other scientists, researchers, and healthcare professionals.

Their duties and responsibilities include:

• Designing and implementing clinical research studies and trials
• Preparing protocols for clinical trials
• Monitoring the progress of research activities and ensuring they adhere to protocols
• Collecting, processing, and managing research data
• Conducting site visits, field monitoring, and data auditing
• Ensuring all research activities comply with regulatory standards and ethical guidelines
• Preparing reports and presentations to communicate research findings
• Communicating with clinical study sponsors, investigators, and other team members
• Participating in patient recruitment and screening activities
• Coordinating and managing logistics of clinical trials, including materials, equipment, and participant care
• Training and supervising junior staff and ensuring they adhere to clinical trial protocols and standards

Clinical Research Associate Job Description Template

We are looking for a dedicated Clinical Research Associate to assist with the design, execution, and maintenance of clinical trials.

The Clinical Research Associate’s responsibilities include creating and implementing research protocols, interpreting the data, writing reports, and ensuring all trials are conducted in compliance with the clinical protocol, and regulatory and ethical standards.

Our ideal candidate has experience in a clinical research environment, with a strong understanding of medical terminology, clinical trials, and research protocols.

Responsibilities

• Assist in the design and development of clinical research protocols
• Monitor clinical trials and studies to ensure compliance with protocol
• Coordinate with clinical investigators and staff to resolve queries and manage data
• Prepare and present detailed reports and documents for clinical trials and studies
• Conduct periodic site visits to ensure protocol adherence and integrity of collected data
• Ensure all adverse events are reported in a timely and accurate manner
• Maintain regulatory documentation according to the regulatory requirements
• Participate in the preparation and review of study reports and manuscripts

Qualifications

• Proven work experience as a Clinical Research Associate
• Knowledge of good clinical practices (GCP), FDA regulations and guidelines
• Excellent understanding of medical terminology, clinical trials, and research protocols
• Proficiency in data analysis and documentation
• Strong organizational and communication skills
• Ability to travel for monitoring visits
• Bachelor’s degree in Life Sciences, Nursing or a related field
• Health insurance
• Dental insurance
• Retirement plan
• Paid time off
• Professional development opportunities

Additional Information

• Job Title: Clinical Research Associate
• Work Environment: Clinical settings, with options for remote work. Travel is required for site visits and meetings with clinical investigators.
• Reporting Structure: Reports to the Clinical Research Manager or Clinical Operations Manager.
• Salary: Salary is commensurate with experience and qualifications, as well as market and business considerations.
• Pay Range: $60,000 minimum to $90,000 maximum
• Location: [City, State] (specify the location or indicate if remote)
• Employment Type: Full-time
• Equal Opportunity Statement: We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
• Application Instructions: Please submit your resume and a cover letter outlining your qualifications and experience to [email address or application portal].

What Does a Clinical Research Associate Do?

Clinical Research Associates (CRAs) primarily work for pharmaceutical and biotechnological companies, contract research organizations, or government health departments.

They play a critical role in the research and development of new drugs, medical devices, and procedures.

They are responsible for setting up, monitoring, and completing clinical trials, which are tests or studies done to evaluate the effects of medical or surgical interventions on human subjects.

CRAs are responsible for ensuring the trials adhere to the trial protocol, are conducted ethically, and are in compliance with regulatory standards and guidelines.

They also ensure that data collected from the trials is accurate, complete, and verifiable from source documents.

Their job involves frequent travel to the clinical trial sites to monitor the progress of the trial, review the data collected, and to ensure the safety and wellbeing of the trial participants.

They are also involved in the design and writing of trial protocols, case report forms, and consent forms, and work closely with doctors, other healthcare professionals, and trial participants.

In addition, they may also liaise with regulatory authorities and ethics committees regarding the approval of trial protocols, amendments, and serious adverse event reports.

Their role is critical in the drug development process and contributes significantly to the advancement of medical science and patient care.

Clinical Research Associate Qualifications and Skills

Clinical Research Associates should have a set of skills and qualifications that align with the job description, including:

• Thorough knowledge of clinical research principles, regulations and procedures to ensure compliance with ethical, legal and safety requirements.
• Strong analytical and critical thinking skills to evaluate and interpret clinical data and identify any inconsistencies or deviations.
• Excellent attention to detail in order to accurately document and report results from clinical trials.
• Strong organizational and time management skills to manage multiple tasks, prioritize effectively, and meet deadlines.
• Effective communication skills to clearly and effectively interact with all levels of clinical staff and participants, and to write comprehensive reports.
• Interpersonal and team working skills to collaborate with a diverse team of professionals such as clinical investigators, medical specialists, and laboratory technicians.
• Problem-solving skills to address and resolve any issues or obstacles that may arise during the conduct of clinical trials.
• Ability to remain adaptable and resilient in high-stress situations or when dealing with unexpected results or challenges.

Clinical Research Associate Experience Requirements

For entry-level Clinical Research Associate positions, candidates usually need 1 to 2 years of relevant experience, which can be obtained through internships, part-time roles, or relevant healthcare positions.

These professionals may also gain experience in roles such as Clinical Research Coordinator, Clinical Data Analyst, or other healthcare-related roles.

Candidates with more than 2 years of experience often develop their clinical research skills and knowledge in entry-level Clinical Research Associate roles or similar positions, where they gain hands-on experience in clinical trial procedures, regulatory requirements, and data management.

Those with more than 5 years of experience may have some leadership experience in their background and are usually ready for roles such as Senior Clinical Research Associate or Clinical Trial Manager.

They may also have completed advanced training or certifications related to clinical research or the specific field of study.

Additionally, many employers prefer candidates with a background in life sciences, nursing, or medical sciences.

Advanced degrees such as a Master’s or PhD in a relevant field can also substitute for some experience requirements.

Clinical Research Associate Education and Training Requirements

Clinical Research Associates (CRA) typically require a bachelor’s degree in life sciences, medical sciences, nursing, or related field.

They also need to have a good understanding of clinical research processes, medical terminologies, and regulatory standards.

Familiarity with Good Clinical Practice (GCP) is also essential.

Many employers prefer candidates with a master’s degree in a health-related field or an equivalent combination of education and experience.

Courses in biostatistics, clinical trials design, and ethics are particularly beneficial for this role.

Some positions may require CRAs to have certification from organizations such as the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

This certification typically requires a combination of education, experience, and a passing score on an examination.

Continuing education is crucial in this field as regulatory guidelines and medical knowledge continually evolve.

Advanced coursework or training in clinical data management, ethics, and patient safety can prove highly beneficial.

Work experience in clinical research is highly valued, which can be obtained through internships, cooperative programs, or direct employment in healthcare facilities or research laboratories.

The role also demands excellent communication, attention to detail, organizational skills, and the ability to handle multiple tasks simultaneously.

Clinical Research Associate Salary Expectations

A Clinical Research Associate can expect an average salary of $76,506 (USD) per year.

The actual earnings can vary significantly depending on factors such as the level of experience, education, the employing company, and the location of the job.

Clinical Research Associate Job Description FAQs

What skills does a clinical research associate need.

A Clinical Research Associate should possess excellent analytical and organizational skills to effectively manage the research process.

They must have strong attention to detail to ensure the accuracy of data and should have excellent written and verbal communication skills to clearly present findings.

Moreover, they should have a deep understanding of clinical trial processes and be able to work collaboratively with various medical professionals.

Do Clinical Research Associates need a degree?

Yes, a bachelor’s degree in life sciences or a related field is typically required for entry-level positions.

However, a master’s degree or a Ph.D. is often preferred, especially for more senior roles.

Clinical Research Associates also require extensive training in clinical practices, ethics, and regulations.

What should you look for in a Clinical Research Associate resume?

When reviewing a Clinical Research Associate’s resume, look for a degree in life sciences or a related field, and any additional qualifications or certifications in clinical research.

You should also look for experience in clinical trials, including study design, data collection and analysis, and report writing.

Proficiency in using clinical research software and familiarity with FDA regulations and Good Clinical Practice (GCP) guidelines is also important.

What qualities make a good Clinical Research Associate?

A good Clinical Research Associate is a critical thinker, able to analyse complex data and identify trends or patterns.

They are meticulous, ensuring that every detail of the research process is accurately documented and reported.

They are also ethical, ensuring that all research is conducted in line with established protocols and guidelines.

Good Clinical Research Associates are also proactive, able to anticipate and resolve issues before they become problems.

What are the daily duties of a Clinical Research Associate?

A Clinical Research Associate’s daily duties typically include designing and implementing clinical trials, collecting and analyzing data, conducting site visits, and ensuring compliance with protocol.

They monitor progress of studies, ensuring they are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.

They may also spend time liaising with doctors or consultants, writing reports, and presenting findings.

There you have it.

Today, we’ve delved deep into the intricacies of what it truly means to be a Clinical Research Associate .

It’s not just about conducting research.

It’s about shaping the future of healthcare, one research study at a time.

With our comprehensive Clinical Research Associate job description template and real-world examples, you’re now ready to take that leap.

But why settle there?

Dig deeper with our job description generator . It’s your essential tool for developing laser-focused job listings or honing your resume to perfection.

Every research study contributes to the bigger picture.

Let’s shape the future of healthcare. Together.

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Clinical Research Associate Job Description

Clinical research associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs, and procedures. A clinical research associate, also known as a CRA, conducts research to ensure these products are safe to allow on the market.

Clinical Research Associate Job Description Template

We are looking for an organized, flexible clinical research associate to oversee clinical trials. The clinical research associate will develop and outline trial protocols, establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials. The clinical research associate will manage multiple aspects of the subjects' welfare. You will conduct regular site visits, generate and distribute internal and external newsletters, prepare final reports, and liaise with interested parties regarding all trial aspects. You will play a leading role in generating and overseeing documentation and records.

To be successful in this role, you should be able to recognize logistical problems and initiate appropriate solutions. Ideal candidates will be detail-oriented, have the ability to multitask, and be able to collaborate with various role players.

Clinical Research Associate Responsibilities:

• Creating and writing trial protocols, and presenting these to the steering committee.
• Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.
• Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
• Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.
• Ordering, tracking, and managing IP and trial materials.
• Overseeing and documenting IP dispensing inventory, and reconciliation.
• Protecting subjects’ confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.
• Conducting regular site visits, coordinating project meetings, and writing visit reports.
• Implementing action plans for sites not meeting expectations.
• Liaising with regulatory authorities.
• Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
• Other tasks and responsibilities as needed.

Clinical Research Associate Requirements:

• Bachelor’s degree in biological science or a related field.
• 2+ years of experience as a clinical research associate.
• Knowledge of the pharmaceutical industry, terminology, and practices.
• Knowledge of FDA regulations and their practical implementation.
• Strong verbal and written communication skills.
• Proficient computer skills.
• Proficient with Microsoft Office Word, Excel, and PowerPoint.
• Ability to manage and prioritize workload effectively.
• Available to travel extensively and on short notice, and ability to manage travel schedules, such as flight schedules.
• Valid driver’s license, proficient driving skills, own reliable transport, and up-to-date car insurance.

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Biochemist job description, chemical engineer job description, clinical research associate interview questions, biochemist interview questions, chemical engineer interview questions, clinical research associate resume.

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How To Become A Clinical Research Associate - A New Scientist Careers Guide

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What does a clinical research associate do?

Clinical research associates (CRAs) are responsible for running clinical research, which consists of trials designed to test new or current drugs/immunisations and analyse their effectiveness, risks, benefits and safety of use. 

CRAs play an important role in the healthcare industry and public health development by helping to design and test new medications, vaccinations and other therapeutic agents.

CRAs can be involved at any stage of a drug development trial, including planning, coordinating and supervising. It is their responsibility to ensure a drug has been appropriately examined and all its risks have been evaluated before it is released to be used publicly.

CRAs most commonly work for pharmaceutical companies or contract research organisations. They might also have to spend some time working in a hospital setting to collect data about the drugs they are analysing. They might also work for universities or public/global health organisations. 

As a CRA, you may have a range of responsibilities depending on your employer, project and level of experience. Typically, CRAs will need to complete tasks such as:

• Designing and writing trial protocols and standard operating procedures
• Presenting protocols and procedures to steering committees
• Designing data collection forms
• Requesting ethics approvals and working with ethics committees
• Liaising with staff conducting the trials, such as doctors or consultants
• Training local staff based on trial-specific standards
• Monitoring operations during clinical trial data collection
• Collecting completed data collection forms
• Performing data management and analysis, and discussing the results
• Closing trials and finalising reports with the help of a statistician

CRAs will work in a team of other research professionals, including contract organisation or sponsor staff, principal investigators and clinical research coordinators.

How to become a clinical research associate

To become a CRA, you need to obtain a degree in medical sciences, life sciences or nursing. This can be in subjects such as biomedical science , anatomy, physiology, immunology , pharmacology or broader degree subjects like chemistry and biology .

Alternatively, you can access a career as a CRA by acquiring a higher national diploma (HND). This is a qualification equivalent to the second year of a bachelor’s degree. HNDs can be beneficial to those who want to enter more practical fields, clinical research included.

Occasionally, you can enter a CRA role from an administrative background. For instance, if you begin working as a clinical trials administrator/assistant and decide you would prefer the role of a CRA, you can complete additional qualifications to do this. However, this will take some time and can be difficult.

Most employees view undergraduate qualifications as sufficient, but in some cases a postgraduate degree may be beneficial. Master’s degrees and PhDs can gain you an advantage when applying for competitive positions, and help you gain more experience in research .

Work experience is key to securing a clinical research job. You can get this at any point in your training, and some universities may help with this. The types of work experience most useful for a CRA role include:

• Academic research
• Pharmaceutical research (e.g. via a pharmaceutical industry placement during your degree)
• Laboratory work
• Nursing or care work
• Work in a pharmacy or medical sales
• Other, similar activities

How long does it take to become a clinical research associate?

Becoming a CRA will usually take around three to four years, depending on the access pathway you choose.

If you opt to complete an undergraduate degree, this can take three to four years. You can then apply to job positions as a CRA straight away. However, if you don’t have sufficient work experience, you may need to start at a lower-level position such as a more administrative job. From here, you can gain more experience and reapply for a higher-level position.

If you choose to obtain a HND qualification, this will take two years. Provided you have sufficient experience, you can then apply for a graduate post as a CRA, but again you may need to gain some extra experience/qualifications in some cases.

If you opt to do a postgraduate degree first, this may take an additional one to three years depending on whether it is a master’s degree or a PhD. Many CRA job positions also allow for completion of postgraduate qualifications alongside the job.

A day in the life of a clinical research associate

Most CRAs work about 40 hours a week, during weekdays. There may be an out-of-hours commitment, for instance if working in a hospital setting monitoring a new drug, but this is dependent on your employer and role.

CRAs can work on multiple trials at a time, in multiple different sites. This will depend on the complexity of each trial and what stage each of the trials is in. Therefore, the role may entail some travelling at times, while other times most of your work will be concentrated on one site.

As a CRA, you will carry out a wide variety of tasks. Some days may be spent writing reports. On other days, you will work on site with healthcare staff , or you might go into your office and attend meetings.

No matter your experience level or how senior your role is, as a CRA, you will need to work in a team with other research and healthcare professionals. You will be communicating with research nurses, doctors, health consultants, investigators and managerial and administrative staff from the company requesting the trial.

The role requires good communication skills, as well as good time management and organisation skills, because carrying out a few different studies at once may mean some tasks clash with one another and you need to prioritise the most important ones.

Clinical research associate: Career options

As with most clinical roles, CRAs undergo lots of continuing professional development (CPD) within their role. There are many training courses available to CRAs to build on their existing skills and develop new competencies.

Most training courses are organised by external bodies, and many are paid for by the employer. One of the organisations that runs training courses is the Institute of Clinical Research (ICR). It provides training in areas such as effective project management for clinical trials and advanced clinical trial monitoring, among several others.

The ICR also offers certificates and a diploma that you can complete to evidence your skills in clinical research. Becoming an ICR member and obtaining courses and qualifications from it can also be beneficial to career development, as you will meet other prominent professionals in your field through interacting with this organisation.

You can also opt to complete a postgraduate qualification, such as a PhD or master’s degree in several different areas, including clinical research and clinical pharmacology .

As mentioned, you may need to climb up the professional ladder to become a CRA, and many people start off as clinical trial administrators or junior CRAs. Within these roles, you might complete tasks such as handling documentation and correspondence or helping to set up trial sites. 

From here, you can move on to becoming a senior CRA as you gain experience. At this point, you will have more advanced responsibilities, such as project management of whole trials and designing case report forms.

If you develop sufficient experience and gain contacts in the field, there is a possibility of self-employment if you want to become a freelance CRA. 

Salary: How much does a clinical research associate earn in the UK and US?

In the UK, starting salaries for CRAs range between £26,000 and £34,000 per year. As a more senior CRA, you might earn between £35,000 and £50,000, and in the most senior positions involving managerial tasks, you might earn upwards of £55,000.

Salaries will vary between regions and employers, as well as depending on your level of experience and responsibilities. Some companies offer additional benefits.

In the US, the average salary for a CRA is $70,000 per year. The range is between $60,200 and $80,900. This can vary depending on the region you work in, your education and experience levels and any additional qualifications you have.

Salaries will also be different as a freelance CRA, and this will depend on the number of clients you have and any business-related expenses you need to cover.

• Prospects. Clinical research associate. Available from: https://www.prospects.ac.uk/job-profiles/clinical-research-associate (accessed Apr 2024)
• CK Group. Clinical research associate (CRA) job profile. Available from: https://ckgroup.co.uk/candidate/job-profiles/clinical-research-associate-cra-job-profile/ (accessed Apr 2024)
• Nikolova, T. The CRA Wizard. How to become a CRA for dummies in 7 steps (or less). Available from: https://www.thecrawizard.com/how-to-become-a-cra-for-dummies (accessed Apr 2024)
• Glassdoor. Clinical research associate career. Available from: https://www.glassdoor.co.uk/Career/how-to-become-clinical-research-associate_KO14,41.htm (accessed Apr 2024)
• Coursera. How to become a clinical research associate. Published Nov 2023. Available from: https://www.coursera.org/articles/clinical-research-associate
• Walters, L. Pharmiweb.jobs. 8 ways to advance your career as a clinical research associate (CRA). Published Sept 2023. Available from: https://www.pharmiweb.jobs/article/8-ways-to-advance-your-career-as-a-clinical-research-associate-cra- (accessed Apr 2024)
• Salary.com. Clinical research assistant salary in the United States. Available from: https://www.salary.com/research/salary/alternate/clinical-research-assistant-salary (available from Apr 2024)

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Clinical Research Associate Job Description

Clinical research associates (CRAs) are responsible for organizing and administering clinical research trials for new or current drugs so that they may assess the risks and benefits of using them. The major responsibilities of clinical research associate jobs are:

They write out the procedures for administering drug trials.

They identify and brief appropriate trial investigators.

They make use of their knowledge of the basics of clinical research to collect and analyze and record data.

They design trail materials and supply the research study centers with the quantities that they need.

They monitor the process of the trial from the start to the finish.

Clinical research associates are always present in the institute of clinical research because of the essential duties that they perform. However, the position is very competitive according to various job websites. As competitive as it is, it is also lucrative. Clinical research associate can work in government clinical research institute , pharmaceutical companies, private owned clinical research institute , etc. Their salaries may differ based on how much the individual companies or employees offer at their different choice of work place. But on the average, clinical research associates are paid around $65,000 per year. This leaves the pay at about $24 - $25 per hour.

There are various factors that can affect how much a clinical research associate (CRA) goes home with at the end of the month or cumulatively at the end of the year. These factors can be the location of the company, that is, the economic strength of the country or city where they are working, the degree or certificate or the level of education and exposure that the CRA has, the number of years if working experience that they have accumulated. These factors work together to determine how much they take home.

You can boost your chances of getting a higher pay, in the region of $85,000 to $90,000 or even more by getting the necessary education and certification. For example, experienced contract CRAs can earn up to $300k .

Skills required to be successful as a clinical research associates include:

A logical and inquisitive mindset with quick thinking.

Good organizational abilities.

Excellent communication skills. Both written and verbal are important.

Commercial awareness.

The basic requirement to be a clinical research associate is an undergraduate degree or a postgraduate degree in related life sciences fields (like biology, toxicology, microbiology, pharmacology, biochemistry), nursing, or medical sciences (like immunology, pharmacy, anatomy, physiology, or medicine). Due to the competitive nature of the job, some people go ahead and obtain a doctorate degree in any of the above mentioned fields. This gives them a better chance of getting a senior level job and increase their promotion prospect.

Beyond academic degrees, you need to be certified to become a clinical research associate. You need certification from organizations like ACRP (association of clinical research professionals) or SOCRA (society of clinical research associates). You will need to obtain certification course and pass the exams to become certified. At ccrps.org , we offer ACCRE accredited courses and insider information on everything you need to know for a career in clinical research. You can click here to see the offers for the courses available.

Take courses from CCRPS and learn more on how to become a clinical research professional:

Clinical Research Coordinator

Pharmacovigilance Certification

Clinical Trials Assistant Training

Advanced Clinical Research Project Manager Certification

Advanced Principal Investigator Physician Certification

Medical Monitor Certification

Discover more from Clinical Research Training | Certified Clinical Research Professionals Course

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Clinical research opportunities in new york city.

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Clinical research roles: how to become a clinical research associate, clinical research associate job description.

Clinical research associates (CRAs) are key actors in facilitating and ensuring successful clinical trial operations. A CRA in clinical research plays an essential role in the trial’s logistics, acting as a liaison between trial sites and the sponsor, and interacting with patients.

What is a clinical research associate?

A clinical research associate (CRA) is responsible for ensuring that clinical trials follow regulations, protocols, and Good Clinical Practice (GCP) guidelines.[ 1 ] The job description of a clinical research associate is centered on monitoring clinical trials to ensure they are conducted safely and effectively, and facilitating communication and coherence between sites and the sponsor. Their duties could include:

• Site selection: CRAs may be involved to varying degrees in selecting appropriate clinical trial sites as well as performing pre-trial site screening visits to verify their capacity to conduct the trial
• Protocol development: CRAs may help the sponsor/investigators develop the clinical trial protocol
• Study start up: CRAs assist with study start up activities, including obtaining regulatory approvals, collecting documentation, training site staff, and conducting site initiation visits
• Site visits: A core responsibility of the CRA is to visit the trial sites, both during the trial (to ensure protocol and regulatory compliance), and after the trial (to perform site close-out)
• Site monitoring: CRAs verify that sites are following the data management plan and protocols to help ensure data is accurate and complete
• Safety monitoring: CRAs may monitor patient safety throughout the trial, including adverse event reporting and serious adverse event management
• Regulatory compliance: CRAs ensure that clinical trials are conducted according to legal and ethical regulations and GCP guidelines

Other potential names for this position include clinical research monitor, clinical trials coordinator, clinical research scientist, or clinical research manager.

Qualifications: How to become a clinical research associate

To become a clinical research associate, you typically need a bachelor's degree in a relevant field such as biology, life sciences, or nursing. A degree in a field that is related to clinical research is generally preferred but is not required for all positions. Some employers may require additional qualifications, such as a master's degree or specialized certification.

In addition to formal education, experience working in the medical research industry is highly desirable. Many CRAs start their career in clinical research working under the supervision of experienced clinical research professionals.

Some of the skills needed to perform the job functions of a CRA include:

• Strong attention to detail and organizational skills
• Excellent communication and interpersonal skills
• Ability to work both independently and as part of teams
• Knowledge of the pharmaceutical and healthcare industries, health and life sciences, and clinical trial processes, regulations, and guidelines
• Analytical and problem-solving skills
• Proficiency in data management and analysis software

If you do not have a relevant degree or prior experience, there are still ways to break into the field of clinical research as a CRA. Here are a few tips:

• Look for entry-level clinical research jobs: Many companies offer entry-level clinical research associate jobs for individuals who do not have prior experience in clinical research. These positions may involve assisting CRAs with managing study activities or administrative tasks.
• Volunteer: Volunteering for clinical research organizations (CROs), research hospitals conducting trials, or other clinical research companies can provide valuable experience and demonstrate your interest in the field. Further, this experience may count as relevant work experience and could qualify you to take the ACRP CRA certification exam (see next section)

Clinical research associate certification

Several courses and clinical research certifications can help you land a CRA job. Two of the most in-demand clinical research associate certifications include SOCRA’s Certified Clinical Research Professional (CCRP) certification and the Association of Clinical Research Professionals (ACRP)’s Certified Clinical Research Associate (CCRA) certification.[ 2 ],[ 3 ] A CRA certification can help demonstrate your knowledge and skills to potential employers.

Similarly, the Certified Clinical Research Professionals Society (CCRPS) offers an Advanced Clinical Research Associate Certification (ACRAC) and course which covers clinical research protocols, clinical trials regulations set by the FDA, Good Clinical Practice (GCP), ICH guidelines, and more.[ 4 ] On a more general level, Coursera offers a specialized certification in Medical Terminology led by Rice University to help you get started on various career paths in the medical field.[ 5 ]

Where to look for clinical research associate jobs

Clinical research associates typically work for pharmaceutical companies, contract research organizations (CROs), academic institutions, or government agencies involved in conducting clinical research. They work closely with a team of clinical research professionals, including principal investigators (PIs), clinical research coordinators (CRC), data managers, and sponsors.

You may be able to find job openings directly with such companies by surveying their websites for open positions. However, you can also look for CRA jobs on job boards such as Indeed[ 6 ] or LinkedIn[ 7 ].

What is the average clinical research associate salary?

The average clinical research associate salary in the United States is around $81,826 (as of when this article was written), with a lower range of $49,052 and a higher range (senior clinical research associate salary) of around $136,499.[8] Salary will depend on multiple factors: level of experience, education, other certifications/qualifications, skillset, and the specific employer.

Clinical Research Associate job outlook

The job outlook for clinical research associates is quite positive, with the high demand for professionals in this field expected to continue. According to the Bureau of Labor Statistics, the employment of medical and health services managers, which includes clinical research associates, is projected to grow 28% between 2021 and 2031.[ 9 ]

In addition, the pharmaceutical and biotech industries are constantly developing new drugs and therapies, which must go through clinical trials before they can be approved. In the USA alone, there are currently over 400,000 active clinical trials.[ 10 ] Thus, there is high demand for professionals with the skills and knowledge to oversee these trials, ensure they are conducted safely and ethically, and optimize their success, particularly in the context of recent advances in technological adoption and new trial models. Moreover, CRA salaries have increased by an average of 15% over the past five years.[ 11 ]

Becoming a clinical research associate is a challenging yet rewarding career path requiring unique skills and qualifications. If you are passionate about medical research and want to make a difference in patients' lives, and you like working with diverse teams on large projects, this may be a promising career path for you. With the proper education, a CRA training program, and some relevant experience, you can become a vital part of the clinical research industry and contribute to the development of new treatments and therapies.

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How to become a clinical research associate (CRA)

Clinical research is an important step in developing and evaluating new medical products. For people with qualifications or experience within life sciences , a career in clinical research can offer many rewarding, interesting and varied opportunities and career paths . With the demand for new prevention methods and treatments ever increasing, clinical research associates are needed by pharma, biotech, medical device companies and CROs around the world. Here are some things to consider if you’re looking to kick-start a career in clinical research and how to become a clinical research associate:

What is a clinical research associate?

'A clinical research associate (CRA) is someone who monitors the running of clinical trials. A CRA may be involved in some or all stages of the clinical trials process depending on the type of position or the employer.

What are the responsibilities of a clinical research associate?

Typically, the key responsibilities of a CRA will include monitoring study sites and clinical activities, updating study documentation, maintaining clinical data systems and coordinating research procedures.

If you are a field-based CRA, you will spend most of your time travelling to different locations, dealing with medical professionals in trial centres, healthcare practices, or hospitals. The remainder of your time may be spent either office-based or working from home, but this will depend on the company. Some companies will have in-house CRA roles who just focus on document review and management and will make site visits only occasionally.

What is the demand for clinical research associates?

Driven by a rise in the number of healthcare facilities, increasing healthcare expenditure, technological and research capabilities, and an aging population, the need for new treatments has increased exponentially in recent times. This has led to a rise in the number of companies hiring for new clinical research jobs and this is likely to keep gaining momentum in the years to come.

What qualifications or training do I need to get a clinical research associate job?

A degree in a life science or other health-related discipline is usually needed to start a career in clinical research. However, there are courses and training available that can help you get a foot in the door if you haven’t got the desired qualifications.

Qualifications:

Although not usually necessary, a Master's degree (MSc. or equivalent) or a PhD can be advantageous and could give you valuable experience in clinical research. A relevant PhD can also be beneficial, as some companies will see this as relevant work experience and count it towards reaching promotions to more senior positions.

Certifications:

The Association of Clinical Research Professionals (ACRP) offers a certification exam to become a Certified CRA. Even though, for most CRA roles, this is not a requirement, being CCRA certified is a real advantage. The exam covers everything a CRA will need to know from scientific concepts and research design to product development and regulation, to data management.

There are lots of courses out there that can provide you with a detailed understanding of what it takes to a be CRA. Before you sign up to anything, make sure it is a recognised training course that is recommended by the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

How do I get the right experience for a clinical research associate job?

Getting your first job in clinical research can be challenging, and many graduates at the start of their clinical research career can become frustrated by the 'catch 22' scenario: they can't find work because of a lack of experience and they can't get experience because they can't find work.

Without relevant work experience, you will be more likely to secure a job as a clinical trials assistant (CTA). A CTA role will help support all processes of the trial and give you the required experience to move into a clinical research assistant role.

Generally, larger companies are far better equipped to take-on inexperienced graduates and are more likely to offer programmes such as graduate assessment days and internships. Research who the top pharmaceutical companies , medical device manufacturers and contract research organisations are, and look out for opportunities on their career websites. Their social media pages are also great places to find out about graduate programmes, so keep a close eye on them too.

You might be able to gain experience by working on academic projects or working within a healthcare body. Although these are good ways to gain experience, moving into a commercial environment later can be quite different and you might have to take a more junior position with a lower salary than you are used to.

Tips for applying to clinical research jobs            

Even with all the relevant qualifications, skills and experience that you need to become a clinical research associate, there can still be challenges in landing your perfect clinical research job . A few simple changes to your approach can give your CV a better chance of success .

Be realistic

Be realistic about the types of jobs that you can attain. If you don’t have industry experience, you are unlikely to be hired for anything above an entry level role. Don't apply to senior CRA jobs or clinical project manager roles unless you have been working as a CRA for some time already and have the required experience. Save yourself the time and effort in making lots of speculative applications and take a more targeted approach.

Highlight your relevant experience

If you are applying for a clinical research associate job , ensure that you read each job description carefully and highlight on your CV the relevant experience that matches the specific description. Your cover letter should be personalised to the specific company and describe why you want to work for that company and which of your skills match the specific requirements of the role. Employers and life sciences recruitment consultants are looking for the most relevant applications and will readily discard those that have put little effort into personalising it.

Make sure you network

Remember, not every company will advertise all its vacancies so you should consider other approaches too. Networking with recruiters and hiring managers and uploading your CV to a database are two great ways that employers and recruiters with CRA jobs can find you.

What are the different career paths you can take?

There are a variety of ways to progress your career in clinical research , with pharma, biotech, and medical device companies and CROs all offering opportunities. Roles will vary from company to company but typically CRAs will progress to be a senior clinical research associate. With the right experience, CRAs will have the potential to progress all the way to clinical director or even VP level.

Once a CRA has reached senior level, there are typically three main routes a career in clinical research can take. You will either be a manager of the trial process, a manager of people or a project manager.

Clinical trial management:

Usually responsible for managing, coordinating, and overseeing various aspects of the trial. Typical duties will involve supervising staff, implementing study tools and documents, overseeing trial budgets and providing strategic input into trials.

Clinical team management:

Responsible for acting as the direct line manager to associates. Clinical team managers will manage and support team members, ensure staff are trained effectively, review the effectiveness of business processes and plan professional development activities.

Clinical project management:

Involved with the planning and directing of clinical trials and is also responsible for evaluating clinical data. Day-to-day tasks include, maintaining study records, ensuring activities are being delivered on time and on budget, interpreting study data and developing trial plans.

Are you already a CRA professional or looking to start your career in clinical research? We might have something that is the right fit for you. We are looking for experienced professionals for a broad and extensive range of clinical research positions. Take a look at our latest clinical research jobs and apply today.

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Senior / Clinical Research Associate Job Description

Senior / clinical research associate duties & responsibilities.

To write an effective senior / clinical research associate job description, begin by listing detailed duties, responsibilities and expectations. We have included senior / clinical research associate job description templates that you can modify and use.

Sample responsibilities for this position include:

Senior / Clinical Research Associate Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Senior / Clinical Research Associate

List any licenses or certifications required by the position: CCRA, CCRP, CCRC, GCP, ACRP, CRA

Education for Senior / Clinical Research Associate

Typically a job would require a certain level of education.

Employers hiring for the senior / clinical research associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Health, Nursing, Pharmacy, Medical, Education, Biological Science, Life Sciences, Life Science, Science, Health Care

Skills for Senior / Clinical Research Associate

Desired skills for senior / clinical research associate include:

Desired experience for senior / clinical research associate includes:

Senior / Clinical Research Associate Examples

• Microsoft Word (.docx) .DOCX
• PDF Document (.pdf) .PDF
• Image File (.png) .PNG
• Coordinates the review of applicable study-specific essential documents including informed consent documents, case report forms (CRFs), subject directed recruitment materials
• Coordinates the processes of Due diligence, site contracting and purchase order preparation invoice tracking
• Coordinates the collection of all the essential documents needed for the investigator initiation package (IIP)
• Ensures management of retain samples
• Ensure all clinical site personnel are trained to study protocol, procedures, and local regulations
• Ship investigational devices and performs device accountability, as applicable
• Prepare for and execute on-site qualification, study initiation, interim monitoring and close-out visits at clinical sites as necessary to ensure study requirements are being fulfilled
• Conduct monitoring visits in compliance with the study specific Monitoring Plan, Standard Operating Procedures, Good Clinical Practices (GCP) and applicable government regulations and guidelines
• Communicate clearly with clinical sites
• Maintain responsibility for site management for pre- and post-market studies ensuring successful conduct of clinical programs, and cross- functional strategies
• Knowledge of relevant medical device regulatory requirements
• Serve as a liaison for clinical trial agreement (CTA) and budget negotiations
• Ensure maintenance of study master file to ensure compliance with internal procedures, and applicable country-specific regulations
• Track progress of clinical studies with regard to budget, study milestones, and deadlines
• Perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support assigned product lines and related clinical studies, staying informed about applicable clinical landscapes and trends
• Participate in study audits, as applicable
• Manage study sites and train the clinical site staff to ensure protocol and regulatory compliance and quality of data
• Independently oversee external CRAs, providing clear communication and direction with regards to the clinical protocol and general trial support
• Participate in the CRO selection and management
• May assist in or be responsible for development of protocols, informed consents, case report forms, monitoring plans, edit specifications, and clinical study reports
• Assist with projection and management of clinical supplies
• Coordinate and/or participate in investigator meetings
• Responsible for updating study timelines and metrics
• Responsible for listing review and resolution of queries during database lock and in preparation of final study reports
• Participate in and/or chair meetings or conference calls with CROs, CRAs and cross-functional study teams
• Provide mentoring to CRAs and Clinical Trial Assistants (CTA’s)
• 5+ years of postgraduate pharmaceutical experience
• Experience with late stage drug development preferred
• Bachelor's Degree in a related field (e.g., biological, medical, public health, physical sciences, engineering) is required
• Ability to work effectively on a cross-functional team is desired
• Must have the functional and technical knowledge and skills to do the job at a high level of accomplishment
• Must possess ability to solves difficult problems with effective solutions
• Track clinical data, regulatory documents, patient enrollment, and data resolutions to assist the timely completion of clinical studies
• Assist in the creation of model informed consents, case report forms, instruction manuals, and monitoring tools
• Assure regulatory compliance of investigational sites with company SOP’s, FDA, and ICH guidelines
• Write visit reports and follow-up letters to investigators
• Set up files, archive study documentation, correspondence and completed case report forms
• Enhance professional growth and development through participation in education programs, current literature, in-service meetings and workshops
• Provide technical and administrative assistance to the clinical department
• Site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
• Involvement in Feasibilities and Start up of studies assigned
• Preparation of study documents and support in submissions
• Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans
• Experience in selection and management of vendors/CROs (Central Lab, IVRS, EDC)
• Bachelor’s degree in a relevant scientific discipline or equivalent
• At least 5 years of relevant clinical experience with at least 2 years in a CRA functional role in the pharmaceutical industry, with global study experience
• Able to perform assignments with general instructions
• Able to solve complex problems, prioritize multiple tasks, plan proactively and accomplish goals within project
• Assist in the preparation of study specific procedures and guidelines
• Responsible for all aspects of Site Management and Monitoring of clinical studies from initiation through close out, including onsite visits and remote monitoring
• Completion of visit reports and tracking in CTMS and other systems within requested timelines
• Working with a local and international project teams
• Responsible for data review as per project specifications
• Review and maintenance of regulatory documents as per study and local requirements
• Liaise between the sites and project teams and establish good communication and relationship
• Assist with training, mentoring, and development of new employees, co-monitoring
• Authorized to work in the US for any employer
• Be less than one hour from a major airport
• University degree in a science related field or are a certified health professional
• Degree in pharmacy, life science or related field
• Ability to mentor and train other monitors in a positive and effective manner
• Ability to evaluate medical research data and proficient knowledge of medical terminology
• Ability to multi-task and prioritize multiple high-priority projects, site questions, and clinical team inquiries while managing responsibilities and deadlines
• Participates in investigator meetings as necessary
• Consistently completes site monitoring reports
• For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out
• Ensure clinical trial management systems containing all site-specific information are maintained and kept current
• Responsible for coaching and mentoring CRAs and providing input into their development
• May participate/lead in global/local task forces and initiatives
• Provide leadership in representing monitoring interests to the study conduct team
• Take a leadership role in developing monitoring organisation characterised by process standardisation, best practice sharing, and continuous improvement
• Provide training for new monitoring personnel and contribute to their performance appraisals, as appropriate
• Individual contributor who demonstrates diligent and self-motivated approach to working in an off-site and independent work environment
• Participate in reviewing protocols, amendments, investigator brochures, Informed Consent Forms (ICFs) and CRFs and facilitate Institutional Review Board (IRB) submission, queries, and approval
• Experience developing tools and processes that increase measured efficiencies of the project
• BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience
• Ability to use a variety of software programs (MS Office)
• Monitoring and/or site/ study management experience
• Demonstrated competence in standard business procedures (SOPs, Global Regulations)
• Experience in Oncology monitoring is preferred

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Clinical Research Associate

Job description overview.

A Clinical Research Associate job description involves managing and overseeing clinical trials of new drugs, medical devices, or treatments. Clinical Research Associates (CRAs) ensure that all trials are conducted ethically, safely and in accordance with national and international regulatory requirements. 

CRAs are responsible for developing study protocols, recruiting and training study staff, monitoring participants’ safety, collecting and analyzing data, and ensuring that all trial documentation is complete and accurate. They also liaise with medical professionals, patients, and regulatory bodies, and provide regular updates to sponsors and stakeholders. 

To be successful in this role, candidates must have strong communication, organizational, and analytical skills, as well as a solid understanding of clinical trial regulations and Good Clinical Practice (GCP) standards. A bachelor's degree in a relevant scientific field is required, and additional qualifications and certifications are desirable. Clinical Research Associate job descriptions typically require candidates to have previous experience in clinical research or related fields.

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Table of contents, job duties and responsibilities.

• Conduct study visits and collect data from study participants
• Ensure compliance with study protocols and regulatory requirements
• Perform site monitoring and ensure accuracy of study data
• Maintain communication with study staff and investigators
• Create and maintain study documentation and reports
• Identify and resolve study issues and discrepancies
• Ensure participant safety and study quality
• Participate in study initiation, planning, and close-out activities
• Provide training and support to study staff as needed

Experience and Education Requirements

To become a Clinical Research Associate in the Science industry, you need to earn a bachelor's degree in a science-related field and have some experience in the industry. Some people even choose to get a master's degree or a PhD. It's also helpful to have experience working in clinical research or a related field, as well as knowledge of regulatory requirements and Good Clinical Practice (GCP) guidelines. Organizations like the Association of Clinical Research Professionals offer certifications that can demonstrate your knowledge and experience. In addition, good communication and problem-solving skills, attention to detail, and the ability to work independently are important traits for this job.

Salary Range

If you're thinking about a career as a Clinical Research Associate (CRA) in the Science industry, you're likely curious about the expected salary range. According to Payscale, the average salary for a CRA in the United States is $64,442 per year, with a salary range of $44,000 to $95,000. However, the salary range can vary depending on factors such as location, experience, and company size. 

For example, a CRA in California can expect a higher salary, with an average of $82,609 per year. Meanwhile, in Canada, the average CRA salary is CAD $60,758 (USD $45,918) per year, according to Indeed. 

Overall, being a CRA in the science industry can be a rewarding and lucrative career path. As with any job, it's important to do your research and negotiate your salary based on your qualifications and experience.

https://www.payscale.com/research/US/Job=Clinical Research Associate_(CRA)/Salary

https://www.indeed.com/career/clinical-research-associate/salaries

Career Outlook

The career outlook for Clinical Research Associates (CRAs) in the Science industry is quite promising. According to the Bureau of Labor Statistics, employment of CRAs is projected to grow 6% from 2019 to 2029, faster than the average for all occupations. With the increase in demand for new drugs and medical devices, the need for CRAs to monitor clinical trials and ensure their safety is expected to rise. Additionally, the trend toward outsourcing clinical trials to Contract Research Organizations (CROs) is also driving the growth in CRA jobs.

In conclusion, if you're interested in a career as a Clinical Research Associate, there are many opportunities available now and in the future. With a growing demand for new drugs and medical devices and the trend toward outsourcing trials, the job outlook for CRAs in the Science industry is looking bright.

Frequently Asked Questions (FAQ)

Q: What does a Clinical Research Associate (CRA) do?

A: A CRA monitors and supervises clinical trials and ensures that they are conducted in accordance with all applicable regulations, guidelines, and protocols.

Q: What are the qualifications for becoming a CRA?

A: To become a CRA, you typically need a bachelor's degree in life sciences or a related field, as well as previous experience in clinical research or a related field. Additional certifications may also be required.

Q: What are some of the day-to-day tasks of a CRA?

A: A CRA's duties may include site selection, study startup, site initiation, routine site management, regulatory compliance, data collection and management, and study closeout.

Q: What are the challenges of being a CRA?

A: CRA work can be demanding and involve frequent travel, long hours, and strict deadlines. The role also requires strong attention to detail, communication and interpersonal skills, and the ability to work well under pressure.

Q: What are the career growth opportunities for CRAs?

A: With experience, CRAs may advance to senior CRA, lead CRA, or project management roles within medical device, pharmaceutical, or biotechnology companies. There may also be opportunities to move into other areas within clinical research and development.

Job Descriptions:

Pharmacovigilance specialist, director of regulatory affairs, process engineer, director of quality assurance, lab technician.

Clinical Research Associate (All Levels)

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• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters using approved business writing standards. Raises observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follow-up on findings as applicable. Participates in investigator meetings as vital. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitates effective communication between investigative sites, client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains and completes administrative tasks such as expense reports and timesheets in an accurate and timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement, as required.
• Bachelor's degree in a life sciences field.
• Clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
• Valid driver's license where applicable.
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain a proven understanding of ICH GCPs and industry regulations and procedural documents.
• Good oral and written communication skills, with ability to communicate effectively with medical personnel.
• Good interpersonal skills.
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues.
• Good organizational and time management skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Ability to manage Risk Based Monitoring concepts and processes.
• Ability to work in a team or independently as required.
• Good digital literacy: proven knowledge of Microsoft Office and ability to learn appropriate software.
• Good English language and grammar skills.

Perks and Benefits

Health and wellness.

• Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Short-Term Disability
• Long-Term Disability
• HSA With Employer Contribution
• Mental Health Benefits
• Fitness Subsidies

Parental Benefits

• Adoption Leave
• Birth Parent or Maternity Leave
• Non-Birth Parent or Paternity Leave
• Fertility Benefits
• Adoption Assistance Program
• Family Support Resources

Work Flexibility

• Flexible Work Hours
• Hybrid Work Opportunities
• Remote Work Opportunities

Office Life and Perks

• Commuter Benefits Program
• On-Site Cafeteria

Vacation and Time Off

• Paid Vacation
• Paid Holidays
• Volunteer Time Off

Financial and Retirement

• 401(K) With Company Matching
• Stock Purchase Program
• Financial Counseling
• Performance Bonus

Professional Development

• Tuition Reimbursement
• Access to Online Courses
• Internship Program
• Mentor Program

Diversity and Inclusion

• Employee Resource Groups (ERG)
• Diversity, Equity, and Inclusion Program

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Home // Clinical Research Associate

Clinical Research Associate

What does a clinical research associate do.

As a Clinical Research Associate (CRA) in clinical operations you are responsible for setting up, coordinating and supervising clinical studies. You plan, prepare and help carry out clinical trials to test new or existing investigational products. This assesses their safety and benefits of use. The work is usually done within pharmaceutical companies or CROs who conduct clinical research on behalf of pharmaceutical companies. Studies are also required within hospital departments that collect information about investigational products.

You are the primary contact for various parties including doctors, researchers, laboratories, pharmacists, ethics committees and others such as the sponsor (usually a pharmaceutical company) or client. In summary, as a CRA you are responsible for ensuring that all the risks and effects of investigational products have been fully examined and approved, prior to their release on the market.

Curious about other clinical jobs? Take a look at clinical trial assistant or clinical project manager . Looking for a starters job? Take a look at starters for the life sciences !

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What responsibilities can you expect as a Clinical Research Associate?

The CRA position is diverse and dynamic. Specific duties can vary depending on the company and you may work on multiple projects. A CRA will generally be required to:

• carry out selection, initiation, monitoring and close-out visits at the participating clinical trial centres, also for logistics and coordination of the study;
• monitor the study to check whether it has been carried out in accordance with applicable laws and regulations;
• develop study procedures, methodology and instructions for clinical trials staff, as well as design data collection tools (case report forms);
• manage study supplies, medication supplies and medication accountability;
• collect, verify and finalise collected data to create reports and present results of findings to other medical staff;
• ensure the safety and well-being of test subjects by liaising with ethics committees;
• submission of clinical trial documents for review and approval by those ethics committees.

Some travel may be required, depending on the terms of the job.

What education and skills do you need as a Clinical Research Associate?

Some of the CRA qualifications and skills must be relevant to the pharma industry. For example, a Clinical Research Associate needs to have a degree in a Life Science*. In summary, you need to have these qualifications, knowledge and personal attributes:

• completed bachelor or masters degree, or a PhD in a Life Science;
• driver’s licence;
• excellent computer skills;
• excellent communication and organisational skills;
• flexible, accurate working and a high level of integrity;
• knowledge of good clinical practice (GCP) with relevant training is an advantage (and conditional on the job itself).

*Relevant subjects include biology, microbiology, medicine, pharmacology, pharmacy, molecular biology, toxicology and immunology.

If you have done some work within a hospital, pharmaceutical company or CRO that would be a bonus.

You should also have knowledge of international guidelines as well as good distribution and manufacturing practice. Employers may expect you to have an understanding of how clinical study management works. This includes monitoring, study investigational product handling and data management. You should also be familiar with the area of medicine or science where you are applying, such as oncology or haematology.

What salary can you expect as a Clinical Research Associate?

CRA jobs in the Netherlands usually offer a salary ranging from € 35.000,- to € 55.000,- a year. This all depends on location, experience and the type of company. A lease car may also be offered. In a Senior Clinical Research Associates role the salary can rise to € 75.000,-. There may also be Contract Clinical Research jobs available, with different terms and salaries.

Do you want to know more about positions as a Clinical Research Associate?

Clinical Research Associate is a position within Clinical Operations . To conduct clinical research, a position within Clinical Operations such as CRA is essential.

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Clinical Research Associate

Clinical Research Associates (CRA) have a vital role in our clinical trials. We own site and patient results. We understand the site and patient ecosystem and our role as site manager.

We perform monitoring and site management activities for Phase I-IV clinical research projects. Our job is to assess the progress of clinical projects at assigned sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Syneos Health and Sponsor standard operating procedures and all applicable local and federal regulatory requirements.

Our CRAs are passionate to change lives, and they do every day here at Syneos Health.

Monika Sr Clinical Research Associate I

As a CRA at Syneos Health, I feel like all of my ideas are heard and appreciated. The company listens and works together to make itself better. I am supported in every possible way of my career.

Hear why Darby has stayed at Syneos Health.

• Functional Service Provider (FSP)    
• Full Service    

Functional Service Provider (FSP)

An FSP relationship is a partnership between Syneos Health and a Sponsor. Every partnership is unique with each one tailored to achieve our customer’s visions and goals. This allows us to grow and evolve with our customers as their portfolio needs evolve.

For Syneos Health it means that colleagues who like structure and predictability, and who truly enjoy relationship building in the work environment, tend to thrive in FSP environments.

Sponsors look to Syneos Health for technical expertise. They expect our colleagues to be an extension of their team and to bring new ideas; demonstrate expertise in technology and processes; escalate recommendations for improvements and take opportunities to innovate. In other words, Syneos Health has a voice.

Full Service

Full Service is a prominent service model among CROs and critical to Syneos Health.

The Full Service environment is dynamic with multiple Sponsors and project assignments. Our Syneos Health colleagues gain broad exposure to therapeutic areas and multiple Sponsors’ processes, roles, technology, financial experience, end-to-end project work and business development opportunities.

Timelines can be fast paced and colleagues in a Full-Service model tend to thrive on variety and are not averse to change, truncated timelines and a degree of unpredictability.

Date Posted

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Syneos Health® is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.

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Senior Clinical Research Associate Job Description, Key Duties and Responsibilities

This post provides detailed information on the senior clinical research associate job description, including the key duties, tasks, and responsibilities they commonly perform.

It also highlights the major requirements you would be expected to fulfill to be hired for the senior clinical research associate role.

What Does a Senior Clinical Research Associate Do?

A senior clinical research associate (CRA) plays a critical role in the planning and execution of clinical trials to test medical treatments and drugs.

The senior clinical research associate job description involves overseeing and managing clinical trials at medical facilities and research sites.

It also entails ensuring that activities adhere to established protocols, guidelines, and regulations.

Senior clinical research associates may directly supervise teams of CRAs and other site personnel involved in trials.

They typically report to the clinical operations manager or director.

Most positions are office-based, but frequent travel is required to visit research sites across the country or globe. Overnight stays near trial sites last weeks or months.

They require a Bachelor’s degree in science/health; higher education like a Master’s degree or RN is preferred.

Relevant experience in clinical trials or research is mandatory.

The core duties of a senior clinical research associate include project management and monitoring of trial timelines, budgets, drug supply chains, data quality, and site performance.

They are also responsible for identifying and troubleshooting any issue.

Other responsibilities they perform can include training site staff, writing reports, submitting documentation to regulatory agencies, and ensuring ethics committee approval.

This role is critical in countries with major pharmaceutical industries driving clinical trials globally.

Employers usually seek detail-oriented candidates with leadership abilities for the senior clinical research associate role.

Positions in the USA require certification from associations like ACRP; other countries have similar requirements. Regulations govern each step of the trials process.

The high level of coordination and troubleshooting makes the senior CRA integral to successfully completing clinical trials.

Next, we’ll look at some specific examples of tasks senior clinical research associates carry out:

Senior Clinical Research Associate Job Description Example/Sample/Template

The senior clinical research associate job description commonly consists of the following duties, tasks, and responsibilities:

• Develop detailed project plans and budgets for clinical trial protocols; oversee and track progress to timelines
• Lead training initiatives and onboarding of research staff at trial sites; provide ongoing support and education
• Create master drug supply forecasts and manage distribution logistics to trial locations
• Conduct on-site and remote monitoring visits of trial locations to review regulatory documentation, drug storage procedures, equipment calibrations, etc. Identify any deficiencies or training issues
• Monitor patient recruitment and enrollment numbers; recommend and assist with recruitment strategies to meet targets
• Review complex datasets and information from trial sites related to safety and efficacy; ensure accuracy and completeness
• Write visits reports, summaries, and other central documents to capture key trial information for lead scientists and regulatory submissions
• Serve as main point of contact for questions, issues, or feedback from site personnel; provide guidance and leadership 
• Track site performance benchmarks and metrics related to enrollment, data quality, protocol adherence
• Develop solutions for operational challenges that arise; adjust plans to minimize impact on trial execution 
• Ensure ethical guidelines, safety regulations, and GCP principles are strictly followed across all trial locations
• Represent trials and sponsor companies at investigator meetings, conferences, trainings, etc.
• Lead or assist sponsor companies with final analysis, evaluation, and conclusions of trial data
• Prepare sites and systems for regulatory inspections; may participate or present in inspections
• Maintain expert level knowledge on regulations, guidelines, systems in area of medical trials
• Communicate status updates, risks, final reports to leadership and key trial stakeholders 
• Develop data validation plans and quality control processes for trial data and systems
• Author SOPs, process documents, and training materials for trial sites and CRA teams
• Perform quality assurance audits on CRA monitoring activities and site performance
• Create agendas, content, and presentations for investigator meetings
• Compile data and generate reports for Data Safety Monitoring Board reviews
• Assist medical writing teams with clinical study report development
• Respond to inquiries from regulatory authorities regarding trial documentation and processes
• Liaise between sponsor companies and central lab facilities coordinating sample analysis 
• Develop contingency plans for trial delays, enrollment issues, site staffing problems etc.
• Create newsletters, status communications to inform trial leadership and stakeholders
• Conduct benchmarking studies on site metrics from past trials to set performance targets
• Review CRA monitoring plans and travel itineraries to provide oversight and optimization
• Analyze site contracts, agreements, and budgets during trial planning and initiation
• Assist with design and evaluation of case report forms, data capture tools, and eCRF components
• Develop transition plans for handoff of trials monitoring activities from remote to on-site visits.

Senior Clinical Research Associate Job Description for Resume

If you have worked before as a senior clinical research associate or currently working in that role and are making a new resume or CV, then you can create a compelling Professional Experience section for your resume by applying the sample senior clinical research associate job description provided above.

You can highlight the duties and responsibilities you have performed or are presently carrying out as a senior clinical research associate in your resume’s Professional Experience by utilizing the ones in the senior clinical research associate job description example above.

This will show that you have been successful performing the senior clinical research associate duties, which can boost your chances of being hired, especially if the new job that you are seeking requires someone with some senior clinical research associate work experience.

Senior Clinical Research Associate Requirements: Skills, Knowledge, and Abilities for Career Success

Here are important requirements that candidates for the senior clinical research associate role may be expected to meet to be hired:

• Expert knowledge of FDA regulations, ICH guidelines, GCP principles, and other standards related to clinical trials
• Leadership skills to manage teams, provide excellent customer service to sites, and troubleshoot complex issues
• Outstanding project management abilities to coordinate many trial details and juggle timelines
• Meticulous attention to detail regarding data, documentation, protocols, etc.
• Excellent written and verbal communication skills for drafting summaries, reports, emails, etc. to various stakeholders
• Strong analytical and critical thinking skills to analyze data, reports, processes and find potential improvements 
• Proficiency with key software platforms for clinical trials like EDC programs, CTMS tools, and eTMF systems
• Ability to exercise independent judgment when making recommendations and decisions impacting trials
• Skills in clinical knowledge, medicine, physiology, and related scientific fields 
• Fluency and literacy in interpreting medical and clinical trial documentation
• Proficiency in CDC principles of Good Clinical Practice
• Excellent organization skills to manage multiple priorities and deadlines
• Ability to maintain compliance across all trial systems and documentation
• Willingness and ability to travel frequently to sites across the globe. May require international travel logistics expertise. 

The senior CRA position combines project oversight skills with keen attention to scientific and regulatory details – not an easy mix of abilities! Employers highly value candidates who already have these competencies.

Senior Clinical Research Associate Salary

The median annual salary for senior clinical research associates in the United States was $126,837 in May 2022, according to the U.S. Bureau of Labor Statistics (BLS).

The top 5 paying states for senior clinical research associates in 2022 were:

• California: $156,335
• Massachusetts: $145,450
• New Jersey: $143,500
• New York: $142,390
• Connecticut: $141,890.

A senior clinical research associate plays an integral role in the complex world of clinical trials required to bring new medicines, devices, and treatments to market.

Their job description involves overseeing the operational side of trials to progress research from laboratories to patient bedsides as safely and efficiently as possible.

As we’ve explored, core duties focus on project leadership, research site management, budget and timeline tracking, and coordinated troubleshooting so data collection stays on track.

Senior CRAs combine scientific backgrounds with sharp project oversight abilities. 

Strong regulations mandate that patient rights, privacy, informed consent, and safety are protected during medical research.

Senior CRAs constantly ensure ethics and protocols are followed at all research sites under their responsibility.

This varied and demanding job provides an opportunity to facilitate life-changing medical discoveries while enjoying excellent salary growth and job prospects.

Candidates with the right balance of clinical knowledge, leadership talents, attention to detail and communication abilities are highly valued by research sponsors and organizations.

Hopefully, this guide provides helpful perspective both for aspiring senior CRAs as well as hiring managers looking to build standout teams for medical research programs that aim to significantly improve patient outcomes and standard of care.

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Clinical Research Coordinator Associate

🔍 school of medicine, stanford, california, united states.

The Division of Cardiovascular Medicine, within Stanford University Department of Medicine, is a dynamic and innovative center dedicated to excellence in research, medical education, and clinical care. Our Division is driven by over 90 faculty members and a cadre of staff who are the pillar of strength in the Division's ongoing efforts into the prevention and treatment of cardiovascular disease.

We are seeking a Clinical Research Coordinator Associate (CRCA) who is passionate about clinical research and wants to deliver results. The CRCA will have the opportunity to work with a robust clinical research team, hand in hand with the Principal Investigators, Clinical Research Manager and other associates in support of the Interventional Affinity Group and the Structural Heart Research Program.

The successful applicant will collaborate with external vendors, and enjoy working in a dynamic work environment. Exceptional diplomacy, interpersonal and communication skills are essential, as is a high degree of integrity. Attention to detail and the ability to manage multiple responsibilities simultaneously are also critical attributes.

If you are interested in supporting translational medicine and contributing to Stanford Medicine’s mission, we invite you to join our team.

Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies.  Coordinate studies from start-up through close-out.
• Determine eligibility of and gather consent from study participants according to protocol.  Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects.  Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.

DESIRED QUALIFICATIONS:

• Relevant graduate degree and 3 years of experience in clinical research preferred.
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional.
• Review Board requirements, and Good Clinical Practices.
• Knowledge of medical terminology.
• Proven ability to work independently and take ownership of a project.
• Proven ability to work collaboratively and cooperatively in a team environment.
• Ability to work effectively in a fast-paced environment with multiple projects and timelines.
• Detail oriented with excellent organizational skills.
• Excellent communication skills.
• Society of Clinical Research Associates or Association of Clinical.
• Research Professionals certification is preferred.
• Fluency in Spanish is a plus.
• Clinical research project management experience.

EDUCATION & EXPERIENCE (REQUIRED):

• Two-year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.  

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong interpersonal skills.
• Proficiency with Microsoft Office.

CERTIFICATIONS & LICENSES:

• Working toward certification(s) to perform basic patient measurements and tests, such as phlebotomy and EKG.  

PHYSICAL REQUIREMENTS:

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

  WORKING CONDITIONS:

• Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
• May require extended or unusual work hours based on research requirements and business needs.
• Occasional evening and weekend hours.  

WORKING STANDARDS:

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide, http://adminguide.stanford.edu/ .  

The expected pay range for this position is $31.73 - $36.54 hourly. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Why Stanford is for You Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:

• Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
• A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
• A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
• Discovery and fun. Stroll through historic sculptures, trails, and museums.
• Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources at [email protected]. For all other inquiries, please submit a contact form .

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

• Schedule: Full-time
• Job Code: 1013
• Employee Status: Regular
• Requisition ID: 104418
• Work Arrangement : On Site

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 School of Medicine, Stanford, California, United States

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Post Date: Jan 29, 2024

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Global Impact We believe in having a global impact

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Besides its contributions to science, health, and medicine, Stanford is also the home of pioneers across disciplines. Joining Stanford has been a great way to contribute to our society by supporting emerging leaders.

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I like working in a place where ideas matter. Working at Stanford means being part of a vibrant, international culture in addition to getting to do meaningful work.

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Join Stanford in shaping a better tomorrow for your community, humanity and the planet we call home.

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CLINICAL RESEARCH ASSOCIATE II

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 

Monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP, and all applicable regulatory requirements.   As needed, provide administrative support to other CRAs.

Responsibilities:

• Implement and monitor clinical trials, with minimal oversight, to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH/GCP guidelines
• Initiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
• Record site visit activities, including but not limited to, observations of clinical conduct, instructions/training given to sites, and action items to be completed as required by OPs or other contractual obligations
• Review and verify accuracy of clinical trial data collected, either onsite or remotely, including query resolution
• Facilitate supply management and ensure clinical sites have necessary supplies to conduct studies according to applicable protocols
• Assess IP accountability, dispensation, and compliance at the investigative sites 
• Ensure all required training is completed and documented
• Perform essential document site file reconciliation 
• Communicate with investigative sites
• Work closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
• Provide regular site status information to team members, trial management, and updates trial management tools
• May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
• May be assigned additional Clinical Operations tasks
• Help create a fun, rewarding and collaborative environment
• 3 years of experience in a Clinical Research environment
• Bachelor’s degree in the Life Sciences or related field highly preferred, or equivalent
• Ability to travel up to 80% of the time
• Ability to instill trust in our customers through a dedicated effort to achieve their goals with quality, speed and efficiency 
• Ability to handle difficult situations professionally and maintain a professional and caring demeanor
• Proven ability to take direction, collaborate in a team environment and work independently
• Must be flexible in adapting to change, with effective time management and organizational skills and ability to manage multiple tasks in a multi-disciplinary, fast-paced work environment 
• Must be punctual, reliable, responsible, creative and highly motivated
• Demonstrate meticulous attention to detail and data evaluation skills
• Excellent verbal and written communication skills required
• Proficient in MS Office Suite applications

ABOUT TE CONNECTIVITY TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, renewable energy, automated factories, data centers, medical technology and more. With more than 85,000 employees, including 8,000 engineers, working alongside customers in approximately 140 countries. TE ensures that EVERY CONNECTION COUNTS. Learn more at  www.te.com and on  LinkedIn , Facebook , WeChat, Instagram and X (formerly Twitter).

COMPENSATION •    Competitive base salary commensurate with experience: $85,120 - $127,680 (subject to change dependent on physical location) •    Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity. •    Total Compensation = Base Salary + Incentive(s) + Benefits

BENEFITS •    A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.

EOE, Including Disability/Vets

Los Angeles, CA, US, 90001

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It has been brought to our attention that there has been fraudulent activity by scammers attempting to represent themselves as Parexel employees or recruiters. These individuals are attempting to reach potential job seekers through online chat interviews and sending false offer letters, representing Parexel without our consent. If you’re concerned that you’ve been contacted by an unauthorized Parexel recruiter or employee, please notify [email protected] . You may also report suspicious fraudulent activity to your local law enforcement agency. Thank you.

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Clinical Research Associate (CRA II/Senior) - US homebased

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.

Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

• Communicator
• Detail-oriented
• Problem-solver
• Self-starter

About This Role

Working with heart

At the end of the day we’re all patients. Because of this, the Parexel team takes our work personally and does it with empathy and heart. When our values align, there’s no limit to what we can achieve. Our clinical operating model drives effectiveness, reduces handoffs and increases employee, client and site satisfaction. As a Clinical Research Associate at Parexel, you will be joining a team with a wide variety of experiences and knowledge. We hire talent that takes initiative to do things better, smarter and faster- people who want to grow personally and professionally.

Your time here

At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor.  CRA’s are accountable for using their expertise to build and maintain the site relationship and ensure they are set up for success. As the clinical sites’ sole point of contact, this includes addressing and resolving site issues and questions. You will also manage site quality and delivery from site identification through to close-out. As a CRA, Parexel will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers. Your hard work may be rewarded through a bonus incentive program, the opportunity to work within multiple therapeutic areas and an opportunity to advance your career in clinical research. If impact, flexibility, and career development appeal to you, Parexel may be your next home.

What you’ll do 

• Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports.
• Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff.
• Protect patients. Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol.
• Drive productivity. Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines while also Ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).
• Ensure quality. Evaluate the quality and integrity of the reported data, site efficacy and drug accountability.
• Execute. Monitor completeness and quality of Regulatory Documentation and perform site document verification.

A little about us

Parexel is proud to be a leading Clinical Research Organization with team members across the globe. As a member of our team, you will get to know your colleagues on a personal level. Have a question? A clinical research leader, project team member, technology “super user” or colleague are a phone call away. Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level CRA role, into line management, Quality, Project Leadership or a variety of other positions, Parexel prides itself on career opportunities for our employees.

More about you

On your first day we’ll expect you to have:

• 18+ months Clinical Research Associate (CRA) monitoring experience in clinical research with understanding of clinical trials methodology and terminology.
• Bachelors or equivalent degree in biological science, pharmacy or other health related discipline.
• Strong interpersonal, written, and verbal communication skills within a matrixed team.
• Ability to work in a self-driven capacity with a sense of urgency and limited need for oversight.
• A client focused approach to work with a flexible attitude with respect to assignments and new learning.
• The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).
• An honest and ethical work approach to promote the development of life changing treatments for patients.
• Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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Potential Career Path

Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.

• Project Management Subject Matter Expert People Management

Employee Insights

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TEAM IMPRESSIONS

Why Clinical Research Associates work at Parexel

Patient-focused in everything we do

We push the boundaries of what is possible to create clinical trials that are inclusive, innovative, and patient-focused

Supportive and inclusive environment

We foster collaboration, teamwork, respect, and inclusivity, to work together to achieve common goals.

Career growth and development

We develop your skills through training, mentorship, and career advancement programs.

Flexible work arrangements

We focus on outputs and results, not where and when you work.

Diverse therapeutic areas and project exposure

We continuously learn from a broad exposure from early to late phase clinical trials and our cros-functional global teams.

Advanced Technology

We recognize the importance of first-time quality to bring treatments to patients faster.

Learn About Our Culture

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Each day, we’re working toward building a deeper connection and understanding with those who count on us – the patients.

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Cell and gene therapies (CAGT) have rapidly emerged as among the fastest-growing spaces in all of biopharma R&D, and Parexel was an early entrant into this space.

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Inhye finds pride in her role in contributing to society. She emphasizes putting patients first and ensuring volunteer safety and comfort during clinical trials. Learn more insights into her journey with Parexel, her reasons for choosing the organization, and the supportive work environment.

Working as a Nurse in Clinical Research at Parexel

Antje and Katharina share insights into working as a Nurse in Clinical Research, where innovative medications are developed through early-phase and first-in-human studies.

Project Leadership Opportunities

Learn how Project Leaders partner with pharmaceutical and biotech clients, manage with determination and With Heart, and our unwavering commitment to patient-centricity.

Meet Rebecca, a Project Leader who is passionate about empathy

Discover Rebecca's insights on effective leadership, collaboration, and patient-centric approaches.

Meet Theodora, a Site Contract Leader

Theodora Chung, Site Contract Leader, offers us an insight into her role, which is to oversee the whole clinical trial budget and contract planning, drafting and negotiations till its execution. She is passionate about working in the team.

Location: Mexico

Learn about Parexel Mexico, where you can be part of a rapidly growing team dedicated to improving patient health. Enjoy flexible work options, a supportive and collaborative culture, and continuous professional growth. Discover how you can make a global impact with us.

New Medicines, Novel Insights

Parexel's insight-generation engine, our people, share perspectives on patient-guided clinical research.

New Medicines, Novel Insights: Advancing Precision Oncology

This report examines some obstacles drug developers encounter and describes strategies to help bring precision cancer medicines more quickly and certainly to market—to benefit an ever-increasing proportion of patients.

Meet David, a champion for disability inclusion

His leadership fosters workplace and clinical research inclusivity. Explore David's inspiring journey from combat medic to Parexel VP and Disability Steering Committee co-lead.