clinical research associate parexel salary

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Clinical Research Associate

Job Details

• 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 the completeness and quality of Regulatory Documentation and perform site document verification.
• Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
• Excellent interpersonal, verbal and written communication skills in either Swedish, Danish or Dutch.
• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

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Senior Clinical Research Associate

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

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

Due to an expanding portfolio, we are currently looking for a CRA II or Senior CRA for our team in Italy.

Key Accountabilities:

Start-up (from site identification through pre-initiation):

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.

Build relationships with investigators and site staff.

Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:

-Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments. -Conduct remote Qualification Visits (QVs).

Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.

Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.

Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.

Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.

Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.

Forecast, develop, manage, and revise plans and strategies for:

-IRB/IEC and MoH / RA submission/approval, -Site activation, -Patient recruitment & retention.

Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.

Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.

Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.

Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections

Work in a self-driven capacity, with limited need for oversight.

Proactively keep manager informed about work progress and any issues.

Maintenance (from initiation through close out):

Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.

Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.

Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.

Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.

Address/evaluate/resolve issues pending from the previous visit, if any.

Follow-up on and respond to appropriate site related questions.

Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.

Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.

Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.

Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.

Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.

Conduct remote visits/contacts as requested/needed.

Generate visit/contact report.

Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.

Assess & manage test article/study supply including supply, accountability and destruction/return status.

Review & follow-up site payment status.

Follow-up on CRF data entry, query status, and SAEs.

Conduct on-site study-specific training (if applicable).

Perform site facilities assessments

Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution

Overall Accountabilities from Site Identification to Close out:

Ensure timely and accurate completion of project goals and update of applicable trial management systems.

Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.

Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.

Ensure that assigned sites are audit and inspection ready

Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.

Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.

Show commitment and perform consistent high quality work.

Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.

Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.

Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.

Provide input and feedback for Performance Development Conversation(s).

Develop expertise to become a subject matter expert.

Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)

Strong problem solving skills

Able to take initiative and work independently, and to proactively seek guidance when necessary.

Excellent presentation skills.

Client focused approach to work.

Ability to interact professionally within a client organization.

Flexible attitude with respect to work assignments and new learning.

Ability to prioritize multiple tasks, and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.

Strong ability to make appropriate decisions in ambiguous situations.

Willingness to work in a matrix environment and to value the importance of teamwork.

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.

Excellent interpersonal, verbal, and written communication skills.

Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables.

Excellent time management in order to meet study needs, team objectives, and department goals.

Proven ability to work across cultures.

Shows commitment to and performs consistently high quality work.

Ability to successfully work in a (‘virtual’) team environment.

Consulting Skills.

Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.

Act as a mentor and role model for other team members.

Effectively enlist the support of team members in meeting goals.

Attention to detail.

Holds a driver’s license where required.

Knowledge and Experience:

Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology

Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience

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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

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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

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Career growth and development

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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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Donata's advancement from an entry-level position to Senior Project Leader at Parexel showcases her dedication to quality and determination to exceed client expectations. Her journey reflects the supportive and growth-oriented environment at Parexel, where passion and hard work pave the way for making a meaningful impact.

Meet Madalina: Clinical Operations Leader

As a Clinical Operations Leader, Madalina invites people to join the wonderful and life-changing experience of working With Heart and passion for the future of medicine.

Meet Carolina, a Senior Project Leader with a stellar growth story

Carolina's remarkable growth story, achieving 5 promotions within 10 years highlights her supportive team and the importance of personal growth. She progressed from Project Specialist to Senior Project Leader and moved from Argentina to the US.

Meet Kathryn: Clinical Research Associate II

Kathryn, Clinical Research Associate II, tells us why she chose Parexel and how she keeps the patient at the heart of everything she does.

Getting the most out of learning at Parexel

We believe that investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career. Ensuring we have a fully trained and capable workforce is a key part of delivering quality work and patient safety.

Benefits & Support

Review how we fit work into our lives, make sure good work is seen, and thrive on a collaborative spirit.

Diversity, Equity & Inclusion

Find out more about how we live our DE&I pillars: Patients, People, and Suppliers.

Join our APEX Program and become a Clinical Research Associate (CRA)

The goal of the APEX Program is to provide foundational clinical research training - including project and system experience - to individuals wanting to become a CRA but are recent college graduates and have less than a year of monitoring experience.

Meet Mwango: SVP & Global Head of Regulatory Strategy

Mwango shares how she came to Parexel after spending 16 years at the FDA to experience the process and considerations from the drug developer’s perspective. Read about her role as a VP-Technical and what valuable advice she offers to those looking to work With Heart™.

What is a Clinical Research Organization?

A Clinical Research Organization (CRO) is a company contracted by a pharmaceutical, biological or medical device manufacturer to manage clinical research studies and other services to support product development. Learn about the four phases of clinical trials.

From Clinical Operations Leader to Director: Catia's path at Parexel

Catia discusses her impressive 15-year career progression at Parexel. Learn from her experiences and insights into people management, the importance of support, and advice for Clinical Operations Leaders.

Parexel's Newsroom

Read our corporate news, press releases, as well as our ESG report.

Meet Cheng Cai: Director, Clinical Pharmacology Modeling and Simulation (CPMS)

Cheng is passionate about advancing clinical research and improving patient outcomes. He enjoys collaborating with his talented team and building mathematical models in his role. Outside of work, he leads an active lifestyle and values quality time with his family through various activities.

Parexel Military Talent Community

We know ‘serving’ is a core value of many of our military community. At Parexel, you can continue on your mission to serve, by joining an organization dedicated to improving the lives of patients worldwide. The skills and values you have developed in your military career or as a military spouse are transferrable to meaningful careers here at Parexel.

Video on Working With Heart™ - Christina's Clinical Operations Manager Perspective

View how Christina reflects on her work experience, her impact on patients and her management style of respect and growth. Christina is leading a team of Clinical Operations Leaders who manage groundbreaking trials in the biotech space.

Blog: Do you take your career seriously

Taking the time to review your career path is an important, but sometimes overwhelming, task that many of us gloss over.

Meet Nadia: Principal Biostatistician

Nadia Seniavina talks about her role as a Principal Biostatistician and what excites her most working in Parexel

Find out about our people, committees, leadership development, strategy, and awards at Parexel and how we embrace DE&I

Watch Replay: CRAs of the Future

Online panel discussion: We discuss what demands CRAs face today, how the role changed and how to prepare the CRA workforce of the future.

Meet Steve Cipollone, a Director within our Data & Technology group motivated by the impact his work has on patients.

Steve started as an intern and now leads the team that supports the technology tools he helped build during his early years at Parexel. Discover how his passion for resilient technology solutions is making a difference in global clinical trials and transforming patients' lives worldwide.

Meet Chrishni, a Senior Project Leader with an exciting global journey

Discover Chrishni's inspiring journey at Parexel, where her love for France led her to relocate from Australia and thrive in her career based in Lyon. She enjoys collaborating with her team and finding a harmonious work-life balance to indulge in her passions.

Meet Doreen, a Project Leader focusing on patient-centric research

Explore Doreen's journey as a Project Leader at Parexel, where she embraces her role in improving patient materials and ensuring patient-friendly and inclusive studies. Additionally, learn about Doreen's onboarding process, her Line Manager's support for work-life balance, and how she enjoys adventures with her children.

Meet Theodora : 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.

Meet Xin Ni: Clinical Data Analyst I

Xin Ni joined Parexel Malaysia as Clinical Data Analyst Intern since 2022, and was shortlisted and hired as a permanent Clinical Data Analyst I (CDAI). Let’s visit her story in the data management team and get more insight of Gen Z workers, The Future Innovators.

Meet Marije, a Clinical Operations Manager who's most proud of becoming a people leader

Marije, a former nurse, is dedicated to enhancing patients' lives through her involvement in clinical research. Marije's exceptional leadership skills and impressive career growth further highlight her as a motivating individual.

Meet Adrian, a Site Care Partner navigating the complex landscape of clinical trials.

Adrian works as an outsourced Site Care Partner (SCP) for a client within the pharmaceutical industry. Learn more about Adrian's experience and insights on how he contributes to the success of clinical trials.

Meet Rachel Smith: Global Head of Rare Disease, CoE

Rachel advocates for rare disease patients and drives innovation in clinical trials at Parexel. Her own diagnosis gives her a unique perspective on patient experiences and outcomes. Discover Rachel's inspiring projects and her dedication to advancing rare disease research.

Meet Jessica, an Associate Project Director guiding trials through the complex regulatory landscape

Jessica works as an Associate Project Director within our Regulatory and Access Global Project Leadership team. Learn more about Jessica's experience and how she contributes to the success of clinical trials.

Meet Anthony, a Senior Principal Medical Writer contributing to lifesaving treatments and therapies

Anthony's has worked as a Medical Writer for more than 17 years. In his current role as Senior Principal Medical Writer, discover how Anthony's work contributes to therapy development and clinical trials.

Meet Stuti, a Senior Regulatory Affairs Consultant guiding clinical trials through development and approval

Working as a Senior Regulatory Affairs Consultant, Stuti is helping to lead clients through the development and approval of products to get treatments to patients faster.

Senior Clinical Research Associate

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Clinical Data Analysis Skill

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Job openings at 1210 Parexel International Limited

Not the job you're looking for here are some other senior clinical research associate jobs in the uxbridge, ma area that may be a better fit., we don't have any other senior clinical research associate jobs in the uxbridge, ma area right now..

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1210 Parexel International Limited , Uxbridge, MA