clinical research management degree

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9+ credits for full-time

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Online Doctor of Professional Practice (DPP) in Regulatory and Clinical Research Management

Pursue a Doctor of Professional Practice (DPP) in regulatory and clinical research management to lead at the forefront of the discovery and advancement of medical products. This program will complement your leadership experience in regulatory or clinical research management and enable you to strategically bring medical products to market. Upon graduation, you can seek advanced roles within commercial industry, community organizations, government agencies, health care institutions, academia and more.

Quick facts

Next start date: 08/22/2024

Total classes: 17

Weeks per class: 7.5

Total credit hours: 60

Degree questions, answered

Have questions about the Regulatory and Clinical Research Management (DPP) ? Fill out this form and we’ll get in touch!

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Prepare for leadership roles in the medical and health care industries

What you’ll learn in this first-of-its-kind program.

• Clinical research leadership.
• Clinical trial design and management.
• Data management and analysis.
• Ethical and legal issues in clinical research.
• Quality assurance and compliance.

Who’s a good candidate for this online doctoral program?

Will my diploma say ‘online’.

No, Arizona State University’s diplomas don’t specify whether you earn your degree online or in person. All diplomas and transcripts simply say “Arizona State University.”

Regulatory science and clinical research management courses

Your courses will focus on building the research, writing and leadership skills needed to navigate the complexities of medical product development. Key topics include quality control and assurance, responsible conduct and ethics, development and regulation of biologics and more. To culminate the program, you’ll complete an applied project on a research topic in the field. You’ll develop an applied project proposal, write the required chapters and give an oral defense.

The leadership roles this doctoral program prepares you for

This doctoral degree prepares you for advanced leadership opportunities in regulatory and clinical research practice settings. You can pursue a variety of growth opportunities in the pharmaceutical, biotechnology and medical device industries. You’ll also be equipped for prestigious positions within government agencies, such as the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). Additional career examples include, but aren’t limited to:

Learn alongside experts in clinical research management

The Edson College of Nursing and Health Innovation is the home to world-renowned and award-winning faculty members. Our faculty’s accomplishments include, but aren’t limited to:

• Fulbright Senior Scholar.
• National faculty nursing awards.
• Rosalynn Carter National Leadership Award in Caregiving.
• Ruth B. Freeman Award from the American Public Health Association.

How to apply

Applicants to the Doctor of Professional Practice (DPP) in regulatory and clinical research management must fulfill the requirements of both the Graduate College and the Edson College of Nursing and Health Innovation.

Application requirements

Applicants must have a minimum of a 3.00 cumulative GPA in an applicable master's program.

All applicants must submit:

• Graduate admission application and application fee.
• Official transcripts.
• Personal statement.*
• Up-to-date curriculum vitae or resume.
• Two professional letters of recommendation.

*Applicants must provide a personal essay (no more than two pages double-spaced) detailing why they’ve selected the Doctor of Professional Practice in regulatory and clinical research management, what led them to apply and what motivates them to earn a doctorate in this field.

Additional admission information

• An applicant whose native language is not English (regardless of current residency) must provide proof of English proficiency.
• On the application, applicants will have an opportunity to provide an example of a published paper or graduate-level scientific paper (optional).
• Please note additional program fees may apply.

Preparing the health leaders of tomorrow

ASU’s Edson College of Nursing and Health Innovation provides a world-class education to students across various health disciplines. We distinguish ourselves by delivering excellent programs and challenging courses led by high-quality instructors.

undergraduate, graduate and certificate programs online.

faculty members.

$13.2 million

in research awards.

Tuition calculator

Use our calculator to estimate your full-time or part-time tuition fees for this program prior to any financial aid. Keep in mind that most of our students receive financial aid, which can reduce out-of-pocket costs. Learn more.

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Healthcare Innovation (MHI)

Starts 08/22/2024

Clinical Research Management – Regulatory Science (MS)

Clinical Research Management (MS)

Regulatory Science (MS)

• School of Biomedical Sciences

Clinical Research Management

Unthsc ms degree in crm ranked as #2 best value program in clinical research in the nation, dorota stankowska, ph.d., director of specialized masters programs.

| E-mail: [email protected]

 2023-24 Student Handbook for Clinical Research Management

Program at a Glance

• Semester credits: 49 (on-campus/hybrid cohort) / 37 (online option)
• Average completion time: 18 months with full-time enrollment
• Both on-campus/hybrid (cohort) and online options are available
• Courses are taught by distinguished educators, researchers, and industry experts
• Enrollment for on-campus/hybrid cohort and online cohort at three starting points each year: Fall, Spring, and Summer

What is a graduate degree program in Clinical Research Management?

Clinical research involves the testing and determining the safety and efficacy of new unapproved products, including pharmaceuticals, devices, and biologics in human subjects. Clinical trials in humans (volunteers and patients) are required before marketing approval by regulatory authorities such as the U.S. Food and Drug Administration (FDA). The law that governs clinical research is spelled out in Chapter 21 of the Code of Federal Regulations (CFR). In addition to requiring and legislating clinical trials, regulatory authorities define the standards by which clinical trials are to be conducted. These standards are known as Good Clinical Practices (GCPs).

In-depth knowledge of the CFR and GCP guidelines as well as international guidelines specifically as they relate to the protection of human rights, prevention, and detection of fraud, and the use of sound scientific principles, is a fundamental requirement for clinical research professionals. These individuals are key personnel involved in the conduct of clinical trials which, in turn, are pivotal in getting new products approved and on the market.

The master’s program in Clinical Research Management provides a strong foundation upon which to build or advance a career. The rigorous curriculum focuses on providing students with a broad-based view of the biomedical sciences, as well as in-depth knowledge of regulatory requirements (CFR, GCP), ethical issues, and both the medical writing and administrative skills necessary to conduct clinical research. As part of the program, all students will complete an internship practicum in clinical studies and use this experience to write the internship practicum report pursuant to receiving the Master of Science (MS) degree. The average time to complete the degree is eighteen months with full-time enrollment.

An applicant to the Clinical Research Management program may apply to either the on-campus/hybrid cohort option or the online option. All students complete a six-month internship practicum experience or a capstone project.

Is the program offered on campus or online?

Both the on-campus/hybrid and online options are available to best meet your needs. You must choose to apply to either the on-campus/hybrid cohort or the online track.

On-Campus/Hybrid Cohort Option The on-campus/hybrid cohort option is designed for the student that works best in a team setting alongside other students with daily faculty interaction. On-campus/Hybrid students will participate in didactic lectures interacting in real time with faculty and other students. With three starting points each year (Summer, Fall & Spring) students in this program can begin classes at the time most convenient for them. The average time to complete the program is eighteen months with full-time enrollment. Visit our How to Apply website for application requirements, deadlines, and other details.

Online Track Option

The online option is designed for the student balancing work and family responsibilities with enrollment. The MS degree is completed online except for an internship practicum experience. Due to the complexity of completing an internship practicum experience in a foreign location or a remote location other than DFW, students enrolled in the online track option will have their internship practicum replaced with a capstone project worth 6 SCH. In addition to the rigorous curriculum, students will have online access to advising. With three starting points each year, students in this program can begin classes at the time most convenient for them. The average time to complete the program is eighteen months with full-time enrollment. Visit our How to Apply website for application requirements, deadlines, and other details.

Campus resources are available from Financial Aid to the Library, including Career Services and the Center for Academic Performance, without traveling to our physical location.

What can I do with a graduate degree in Clinical Research Management?

Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development.

Clinical research professionals can hold a multitude of positions either in industry, at the investigational site, or in the clinical research service profession either at a contract research organization (CRO) or a site management organization (SMO). Job titles may include, but are not restricted to, Clinical Research Associate (CRA), Clinical Research Scientist (CRS), Clinical Research Coordinator (CRC), Medical Writer, Clinical Trial Auditor, Clinical Trial Monitor, Product Safety Specialist, Clinical Research Trainer, etc. Industry (sponsor) and service professions (CRO, SMO) usually provide technical and managerial career paths and ample growth opportunities.

Typically a clinical research coordinator who has been involved with the implementation and coordination of a clinical trial at a research site (private, clinic, hospital), will advance his/her career by switching to either industry or one of the service professions. Others make the reverse switch because they prefer the interactions with the patients, or they may want to travel less than what is typically required from a clinical trial monitor. Turnover in all these industries and positions is relatively high because of the growing variety of choices clinical research professionals have, especially after they have accumulated a number of years of experience.

What are the program requirements?

Each student is responsible for the completion of the requirements for the Clinical Research Management program according to the procedures that follow. Each item must be completed in the sequence and time period indicated. Forms are subject to revision at any time and can be obtained from the SBS Forms and Guidelines site.

• The admissions committee will review all applicants for acceptance into the MS program in Clinical Research Management. A student must have a bachelor’s degree and must meet the general admission requirements as described in the catalog in effect at the time of application.
• The student will be assigned a major professor and an advisory committee consisting of the major professor and an advisory committee consisting of the mentor and two other graduate faculty members. The names of these individuals will be filed on the designation of advisory committee form with the SBS Office of Student Services. A degree plan must also be filed at this time.
• After the coursework has been completed, the student will enroll in Internship Practicum (BMSC 5697) or a Capstone project. The student will complete a six-month unpaid internship at a site previously approved by the graduate school. The student is responsible for transportation to and from the site. During this time, the student will learn how to perform the duties expected of particular clinical research positions in clinical research centers such as a hospital or clinic, pharmaceutical or medical device company, a clinical research organization or site management organization. The student must be in good academic standing prior to beginning the Internship Practicum. Exceptions to this rule can only be granted by the dean or his designee. Online track students will have the option of completing a capstone project in lieu of the internship practicum.
• A formal research proposal describing how the practicum is to be spent must be approved by the advisory committee and submitted to the graduate school.
• At the conclusion of the practicum/capstone project, the student will present his/her work as both oral and written reports. The oral presentation will be open to the public and will then be followed by a private defense with the advisory committee. The student must submit a first draft of the practicum report/capstone project and internship daily journal to the major professor for review prior to the public seminar. The major professor must approve the internship practicum report/capstone project report before it is distributed to the committee members by the student. The final written report should be given to the committee no later than two weeks before the formal defense. Students should coordinate the reservation of a seminar room with the Graduate School office at least one month prior to the defense. At this time the committee will either approve/or not approve the work of the internship and the report. If not approved, the student may have a chance to revise the report or repeat the practicum one time at the discretion of the committee. The major professor, together with the other members of the committee, will assign a letter grade to the practicum/capstone project. The report must be submitted in accordance with the instructions for completing graduation requirements within the deadlines for graduation published in the academic calendar. A more detailed description of the internship practicum/capstone project and report requirements may be found in the Internship Practicum Guidelines available on the SBS Graduation website.
• It is strongly suggested that the student and major professor, as well as the major professor and the on-site mentor, communicate on a regular basis to review the student’s progress during the practicum/capstone project.

The graphic below details the curriculum requirements.

Internship Practicum (BMSC 5697) 18 SCH with practicum report/defense Total Semester Credit Hours = 49 Online Track Capstone Project 6 SCH with project report/defense Total Semester Credit Hours for Online Track = 37

Internship Practicum (BMSC 5697)

The Internship Practicum provides a hands-on training experience for the graduate student whose master’s degree will be in the specialized discipline of Clinical Research Management. The program director will identify approved, on-sight and off-campus internship opportunities in north Texas and will work to place students at suitable sites. The internship may take place either on-campus or at an approved off-campus site in the Dallas-Fort Worth-Denton Metroplex and, in some cases, at a site in other parts of the state or country. UNTHSC does not offer any remuneration to the student when he/she is enrolled in BMSC 5697 and the student should not expect to be paid as an intern.  Students will be expected to provide for their own transportation and housing needs during the internship experience. The student is expected to keep a daily journal during this experience. At the end of the practicum, the student will write a report detailing the activities of the internship. The student’s advisory committee must approve this report together with the daily journal. The student must make a formal presentation to the advisory committee and defend the work at this time. A copy of the report must be submitted within the appropriate deadlines for graduation as published in the SBS Academic Calendar .

Capstone project (online track students only)

The capstone project is a required component of the online Clinical Research Management Master’s program that will replace the requirement of an internship practicum. The students will enroll for 3 SCH each in two semesters for a total of 6 SCH for their capstone project. The purpose of the capstone project is to equip students with the knowledge and skills required to contribute to the field of clinical research management. This individualized scholarly work may consist of a detailed case study, literature review, and data analysis project or a clinical research project, or a clinical quality improvement project. Students will be paired with a mentor from UNTHSC or our partner healthcare organizations to oversee their work. At the beginning of the capstone, the mentor and student will identify a topic or a specific problem to address or investigate. They will then construct an action plan or research proposal and the student will conduct the data analysis/literature review. At the end of the project, the student will complete a project report and do an oral presentation of the project.

This page was last modified on January 25, 2024

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• MS in Clinical Research

For more information, please visit the Graduate Medical Sciences website .

The Master of Science in Clinical Research is a rigorous program that meets the needs of health professionals engaged in the full spectrum of patient-oriented research. This flexible degree program is designed for a variety of professionals, including physicians who will plan and oversee translational research and clinical trials; research nurses; study coordinators; managers in clinical research and site management organizations (CROs and SROs); and professionals in the pharmaceutical, biotechnology, and medical device industries.

Learning Objectives

Upon completion of the MS in Clinical Research , students are expected to:

• Demonstrate the ability to design and conduct clinical research, analyze results, and answer a research question.
• Demonstrate the ability to read and critique the clinical research literature.
• Present clinical research findings (from literature or their own research) to peers.

Our Mission

Inspire, Instruct, Innovate. The MS in Clinical Research program is dedicated to the discovery, development, and application of knowledge as it pertains to all areas of clinical research. Our mission is to foster an engaging and effective educational environment that promotes the pursuit of outstanding teaching and learning through formal classroom and practical training. With established collaborative relationships with pharmaceutical, biotech, and academic institutions, students are provided with unique opportunities to pursue clinical research in areas that are of personal and professional interest.

We hope that the information you receive about our program encourages you to pursue your graduate degree in clinical research with us. If you are interested, click here to get your application started. We accept applications for both September and January start dates.

Degree Requirements

The program consists of three components:

• Minimum of 32 graduate units; 22 required and 10 elective
• Clinical research practicum; hands-on involvement in a clinical research project
• Capstone Project; clinical research project resulting in a written research paper

Master of Science in Clinical Research degree candidates are required to complete all of the following:

A minimum of 32 units at the graduate level across four terms. These must include the following 22 units of required coursework:

• GMS CI 631 Management of Clinical Trials (4 units), spring term
• GMS CI 640 OL Regulatory and Compliance Issues (4 units), spring term
• GMS CI 670 Biostatistics with Computing (4 units), fall term
• GMS CI 675 Designing Clinical Research Studies (4 units), fall term
• GMS CI 790 Seminar in Clinical Research (2 units), spring term
• GMS CI 794/795 Practicum in Clinical Research (2 units), fall or spring term
• GMS CI 804/805 Research (2 units), fall or spring term

A minimum of 10 units in elective coursework: A wide variety of courses offered in Graduate Medical Sciences will count toward elective units. A minimum of 10 units must be taken as electives or directed study. Up to 4 units across two terms may be taken as the practicum or for research. Students who have completed one or more of the required courses before matriculation may acquire “advanced standing” for that requirement. “Advanced standing” means that the student may waive the requirement but would need to replace the course requirement units by taking an elective course(s). The student would not need to retake the course requirement. To waive a course requirement, students must speak to their academic advisor and complete/submit a “Petition for Approval of Advanced Standing.” No transfer units from other BU departments or institutions will be accepted.

Completion of a minimum of 240 hours of a practicum in clinical research is required for the degree. The goal of the practicum component is to provide the student hands-on exposure to clinical research. The student will work with a mentor and will be actively involved in the development, execution, and evaluation of a clinical research project or projects. During the practicum, it is expected that the student will be exposed to some or all of the following: clinical research planning, protocol preparation, interaction with Institutional Review Boards, regulatory requirements, selection of subjects/patients for the clinical trial, study monitoring, and data analysis. The practicum may be completed with a mentor who is actively conducting clinical research studies within a clinical research or hospital setting. It may also be performed under the direction of a clinical research professional within a drug, device, or biotechnology company, a clinical research organization (CRO), or site management organization (SMO) actively involved in clinical trials.

Capstone Project  

Students in the MSCR program are required to complete a capstone project that provides a culminating experience and applies the principles and methods learned in the coursework to a real-life clinical study.

The goal of the capstone project is to demonstrate the student’s understanding of the clinical research process from both a theoretical and a practical point of view. Students conduct their capstone research in a wide variety of settings, including academic medical centers and local drug or device companies.

Students generally identify their capstone mentor and develop their capstone proposal while they are completing their coursework or practicum. The capstone project must involve the analysis and interpretation of data. Students are encouraged but are not required to conduct primary data collection. Once the final draft is approved, the student gives a short oral presentation on their capstone project to the readers, capstone mentor, MSCR students and faculty members, and any other interested parties. The purpose of the oral presentation is to demonstrate the student’s ability to (1) describe clearly the capstone topic, methods, and results, (2) demonstrate their understanding of study design and analytic principles and methods, and (3) place their research into a clinical context.

Additional Information

Students are required to abide by the rules and regulations of Graduate Medical Sciences:

• Units toward a degree will only be obtained from a passing grade (A to B–).
• Grades of I and C+ or lower are interpreted as failures. A student receiving such grades in a total of 8 unit hours may be terminated. A student receiving a failing grade will not be permitted to take a makeup examination.
• A degree candidate, after completing all departmental course requirements, must register each regular term as a continuing student and pay the continuing student fee until all remaining degree requirements are completed.

Please visit the Graduate Medical Sciences website at bumc.bu.edu/gms to view detailed administrative policies and procedures.

Study Options

The MSCR program can be completed on either a part-time or full-time basis depending on the student’s goal. Most of the courses take place in the late afternoons or early evenings to accommodate those who work during the day.

The program is designed so that a full-time student may complete their coursework in one academic year, including summer. Practicum and capstone components of the program should begin near completion of the coursework and the time frame for finishing them will be determined on a student-by-student basis by the program director or assistant director. A full-time student is enrolled in 12–18 units per academic term (fall and spring).

Part-time students must register for at least 4 but not more than 11 units each academic term until all course requirements are fulfilled.

Continuing Student

Students who have completed all departmental course requirements (32 units) must register each subsequent term as continuing students until all requirements for the degree have been completed.

Nondegree Option

A number of individuals with an accredited bachelor’s degree or its international equivalent, who are uncertain as to whether they want to enroll in MSCR, have the option of taking a few of the MSCR courses as a nondegree student, and may then make their decision about completing the MSCR application process. We allow the transfer toward the MSCR degree of up to 2 MSCR courses (8 units) taken as a nondegree student. Applicants must submit a copy of the Application for Admission, indicating the specific objectives of the studies/courses sought. In addition, the applicant must submit (with the application) the nonrefundable application fee. Nondegree applicants are not eligible for University sources of financial aid or aid that requires matriculation in a degree program.

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Master of Clinical Research

Clinical research is advancing at an unprecedented speed. especially here..

Admissions   |  Curriculum   |  Tuition   |  FAQs   |  Information Sessions

The Master of Clinical Research (MCR) program is an interdisciplinary graduate degree program offered entirely online.

The clinical research industry relies on professionals that are specially trained to navigate the complex world of medical product development and clinical research to ensure safe and effective evidence-based diagnostics, drugs, biologics and devices for the publics’ health.

May 31, 2023

Master of Clinical Research degree program awarded prestigious accreditation

Online program the second of its kind in the U.S. to earn academic accreditation |  Read more >

The 100 percent online MCR program prepares students to excel as administrators, regulatory specialists and other professional roles on clinical research teams. Graduates are prepared for rewarding careers as clinical research coordinators and managers, clinical research associates (monitors), project and data managers, clinical research trainers, regulatory compliance officers, institutional review board specialists, research quality analysts and many other positions in the clinical research enterprise.

The program offers a multidisciplinary curriculum, covering the theory and practice of research methods and statistics, the ethics of human subjects research, the science of pharmacology and medical product regulation, and the business of research operations and management. Coursework is taught by the College of Nursing and Pharmacy. This program is open to applicants with any undergraduate degree.

The program concludes with a culminating project where students have an opportunity to apply best practices in clinical research operations or administration.

In the Research Realm with Emily Rice

Two interdisciplinary specializations are offered:

• Clinical Research Management
• Regulatory Affairs

Students who graduate from the MCR program are eligible to sit for ACRP and SoCRA basic certifications with one-year post graduation clinical research experience, and for higher level ACRP and RAPS certifications after a requisite time period working in the field. For more information on certification opportunities, please visit:

• ACRP Clinical Research Coordinator Certification (CCRC)
• SOCRA Clinical Research Professionals Certification (CCRP)
• RAPS Regulatory Affairs Certification

As a member of the  Consortium of Academic Programs in Clinical Research , the MCR graduate degree is designed as a competency-based program. The program’s core curriculum aligns with the  Joint Task Force for Clinical Trial Competency  and CoAPCR accreditation standards.

Core Competencies

• Scientific Concepts and Research Design
• Ethical and Participant Safety Considerations
• Investigational Product Development and Regulation
• Clinical Study Operations (Good Clinical Practice)
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communications and Teamwork

The Ohio State University is authorized to offer MCR in all 50 U.S. states and territories (limited authorization in Colorado at present). For more information on state authorization requirements and disclosures related to online programs, please visit  online.osu.edu/state-authorization/disclosures .

If you are looking for information on the interdisciplinary online MS in Translational Pharmacology graduate program in clinical and safety pharmacology and toxicology, please visit the  College of Pharmacy website .

Application Deadlines

• Spring Semester: Opens: March 1 Deadline: July 31
• Summer semester: Opens: August 1 Deadline: November 30
• Autumn semester: Opens: December 1 Deadline: March 1

[email protected]

Program Info and Updates

Want to learn more about the program and receive updates about overview sessions, applications and more? Request information below.

Message from the Director

We provide students with the knowledge and real-world, hands-on skillsets that enable success in clinical research careers. When you join our program, you'll become part of a collaborative and supportive community led by devoted faculty, staff and students. In addition, the flexibility of the program allows it to be accessible to most working professionals. The MCR program admits students three times per year. As working professionals, the majority of students (82%) graduate in one to two years through our full-time or part-time options. Our students have contributed to improvements in the clinical research enterprise.

We are pleased to announce that in May 2023 our program became accredited by the Commission on Accreditation of Allied Health Education Programs (CAAHEP). It was the second graduate program to achieve this recognition.

Video: Student Experience

Become a Part of the Cutting Edge in Clinical Research: Educational and Career Options Abound with Dr. Carolynn Thomas Jones  

The Clinical Research program at The Ohio State University is accredited by the Commission on Accreditation of Allied Health Education Programs ( http://www.caahep.org ) upon the recommendation of the Committee on Accreditation of Academic Programs in Clinical Research (CAAPCR). 

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“I learned how to interact with patients from an ethics and safety perspective, as well as how to make sure that research is compliant with domestic and international regulations. You can learn a lot while working in the field, but you won’t learn it to the extent that the MCR program will teach you.”

Programs in Clinical Research

1 year | full-time, 2 years | part-time, boston university medical campus.

Boston University’s programs in Clinical Research aim to meet the needs of health professionals engaged in the full-spectrum of patient-oriented research. We offer both master’s degree and certificate programs to individuals seeking careers in clinical research in industry or academic settings.

Clinical Research program offerings:

• Master of Science in Clinical Research (MSCR)
• Online Graduate Certificate 
• Dual Degree in Medical Sciences and Clinical Research
• Dual Degree in Medicine and Clinical Research

About the MS in Clinical Research Program (MSCR)

Located in Boston’s South End at the Boston University Chobanian & Avedisian School of Medicine, the Master of Science in Clinical Research Program (MSCR) has been in existence since 2001 and is ranked #1   by College Choice among universities that offer an MS in Clinical Research.  As an entity of BU CAMED, students are provided with opportunities and are exposed to resources that are part of the Chobanian & Avedisian School of Medicine , the School of Public Health , the Goldman School of Dental Medicine , Boston Medical Center , two VA Administrations, and BioSquare.  All of this offers students endless opportunities for personal, academic and professional development.

The Master’s in Clinical Research program, which is a STEM program, teaches students the scientific fundamentals of human research. Courses in our curriculum provide an in-depth look at all of the key elements in clinical research, including: trial design, trial management, biostatistics, ethical issues, and clinical research regulations. Other courses cover how basic science discoveries translate into clinical research and new therapies. The total course requirement is 32 credit hours: 22 hours are required curriculum, including practicum and research credits; 10 hours are elective courses. Students will also complete a research “practicum”; a hands-on involvement in a clinical research project under a scientific mentor. The final requirement for the degree is to conduct clinical research, write, and present a capstone project.

Who is this program designed for?

The Master’s in Clinical Research program is designed for anyone interested in a career in clinical research. This includes those with MD or PhD degrees interested in becoming independent principal investigators, as well as those with bachelors or masters degrees who seek advancement in a research career in industry or academic settings.

Online Graduate Clinical Research Certificate

If you are not ready to commit to our Master’s program, we also offer an Online Graduate Certificate in Clinical Research.   This certificate program involves 4 courses across two semesters, and can be completed in one academic year.

Learning Objectives

Upon completion of the Master’s in Clinical Research program, students are expected to:

• Demonstrate the ability to design and conduct clinical research, analyze results and answer a research question.
• Demonstrate the ability to read and critique the clinical research literature.
• Present clinical research findings (from literature or their own research) to peers.

Our Mission

Inspire, Instruct, Innovate … The MS in Clinical Research program is dedicated to the discovery, development, and application of knowledge as it pertains to all areas of clinical research. Our mission is to foster an engaging and effective educational environment that promotes the pursuit of outstanding teaching and learning through formal classroom and practical training. With established collaborative relationships with pharmaceutical, biotech, and academic institutions, students are provided with unique opportunities to pursue clinical research in areas that are of personal and professional interest.

We hope that the information you receive about our program encourages you to pursue your graduate degree in clinical research with us. If you are interested, click here to get your application started.

If you would like to visit our campus or have any questions about our program, please contact Stacey Hess Pino at [email protected] . We look forward to meeting and/or speaking with you!

Janice Weinberg, ScD Director, MS in Clinical Research; P rofessor, Department of Biostatistics

Stacey Hess Pino, MS, MS Assistant Director, MS in Clinical Research; Director, Online Graduate Certificate Program in Clinical Research; Assistant Professor, Department of Medical Sciences & Education

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MS in Clinical Research

Program Description

The MS in Clinical Research is a 36-credit degree program. The curriculum is designed to accommodate clinicians’ busy schedules, with courses offered on Wednesday afternoons.  For most students with concurrent clinical obligations, the degree requires a minimum of 3 years; the time required for degree completion depends on the amount of time and effort a student devotes to the program. Detailed information about policies for McGovern Medical School and the MS Degree Program can be found in the Medical School Catalog (see current McGovern Medical School (MMS) Catalog, p 26-35).

All MS degree students must also complete the Clinical Research Curriculum , a 2-year series of introductory courses composed of a weekly lecture offered on Wednesday evenings. Successful completion of the Clinical Research Curriculum will yield up to 12 credit hours toward the MS degree credit hour requirements.

Coursework for MS Degree

The curriculum for the MS Degree Program consists of two tracks — a Patient-Based Clinical Research Track and a Translational Research Track. In either track, the specific Advanced Courses chosen by an individual student will depend on his/her previous training and course work and on career goals. All students are expected to take the Advanced Biostatistics course unless they can demonstrate comparable competency in this area. Most students in the Patient-Based Clinical Research Track will take Advanced Courses in study design, whereas most students in the Translational Research Track will take Advanced Courses in molecular biology and/or genetics.

In addition to the formal coursework offered through the Clinical Research Curriculum and the Advanced Courses, MS students are required to complete three practica and a thesis, which is ultimately orally defended. See detailed curriculum for MS Program.

Each MS student will be assigned a Program mentor who provides methodological expertise and guidance in meeting MS program requirements. In addition, the student must identify a departmental mentor from his/her own medical department or institution to provide content expertise in the student’s specific area of clinical research. An ideal departmental mentor should be an active clinical investigator with independent funding, who is well-known and well-respected in their field.  He or she will play a key role in the completion of the practica and thesis components, especially study design and analysis. He or she should be committed to the student’s participation in the Degree Program.  In addition, a departmental mentor should have the time and willingness to help the student define his or her research goals and give feedback on thesis and practica components in a constructive and timely manner.

The faculty in the Center for Clinical Research and Evidence-Based Medicine supervise the MS Degree Program, serve as Program mentors, and teach the classes. All are full-time faculty at McGovern Medical School and/or the School of Public Health. The Center faculty are actively involved in clinical research and bring to the Program a broad range of expertise, including biostatistics, clinical trials, epidemiology, ethics, and health care economics. This structure allows for a wide diversity of training and skills among the faculty and acknowledges the importance of ongoing participation in research and clinical activities for the career development of the Center faculty.

Admission Requirements

With rare exceptions, the MS Degree Program is primarily intended for those with a graduate healthcare-related professional degree (e.g., MD, DO, PharmD) who hold a current full-time faculty or fellowship appointment at an academic institution.  Applicants should have a commitment to pursue a career as an independent clinical investigator. The rapid pace of the curriculum assumes a working knowledge of clinical medicine and an excellent scholastic aptitude.

Medical graduates without postgraduate clinical training, clinical research coordinators, and other study personnel are strongly encouraged to participate instead in the Clinical Research Curriculum. Not sure which program is right for you? Click here

Applications for the MS Degree Program are accepted annually from March 15 until June 15 through the Office of the Registrar. Only complete applications will be reviewed. Applications may also be made for non-degree status (deadline October 15).  See detailed admission requirements and process .

Costs for Advanced Coursework in the MS Program will follow the Tuition and Fee Schedule for the UT System and are subject to change. The total cost of the program will depend on the number of courses taken and the duration of enrollment. At current rates, the total cost of the program is estimated to be $3500-4500 for students who qualify for Texas residency status and $12,500-16,000 for non-residents. Texas residency status is determined by the Registrar’s Office for individual students using criteria established by the Texas Higher Education Coordinating Board.

Information for Current Students

Visit this page for more detailed information.

For more information regarding the MS Degree program, please email Deborah Garcia , CRC and MS Program Coordinator, or call our office at (713) 500-6708.

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Topics: Clinical & Translational Research , Five Questions

How to Accelerate Clinical Research

Five questions with michelle beck and yemi talabi-oates on making connections..

At Brigham and Women’s Hospital (BWH), oncologists who’ve been doing gene therapy trials for a decade are teaming up with researchers in other fields to apply their knowledge to the new wave of non-oncology cell and gene therapy studies and avoid recreating the wheel.

And at Beth Israel Deaconess Medical Center (BIDMC), one researcher’s challenges enrolling Black patients for a diet intervention study led to the development of a satellite center at a community-based clinic, which other researchers are exploring for their own studies.

These are among the ways Harvard Catalyst’s Connector sites facilitate and accelerate clinical/translational research across the hospitals affiliated with Harvard Medical School (HMS). Connector links investigators to the medical centers’ sprawling clinical research enterprises and troubleshoots research bottlenecks. (Boston Children’s Hospital and Mass General Hospital also have Connector sites.)

Need a research problem solved?

The premise behind Connector is that clinical research can be challenging, especially in complex academic healthcare environments. Individual scientists can’t do it alone. Connector sites help researchers get science done right–hopefully the first time–while maintaining the highest standards for patient protection, regulatory compliance, and quality.

Connector draws upon the collective expertise of HMS-affiliated institutions to guide studies through the lifecycle of science. For investigators struggling to recruit or wrestling with logistics, the programs offer a kind of life-raft of resources and support, big or small.

As the administrative directors of Connector sites at BIDMC and BWH, respectively, Michelle Beck and Yemi Talabi-Oates are like the Ghostbusters of translational research: They are “who you gonna call” when you’ve got a research problem to solve.

We caught up with them both in one Zoom to find out what they wish investigators knew about Connector.

What’s your cocktail-party summary of what Connector is?

MB: A cocktail-party summary is hard because Connector does a bit of everything, depending on what the investigator wants. Connector sites are really good at figuring out how to set studies up. Our special sauce, so to speak, is the experience in knowing how to make things work.

“Connector sites are really good at figuring out how to set studies up. Our special sauce, so to speak, is the experience in knowing how to make things work.”

At BIDMC, Connector encompasses our Clinical Research Center, a full-service operation providing research coordination and personnel for the lifecycle of a study, including recruitment. We provide laboratory, dietary, specialized nursing–because research nursing is a little different than clinical care nursing–and all affiliated services for inpatients and outpatients in our own research space as well as in other locations.

We help research teams get the tools and resources they need in other parts of BIDMC or across the network of HMS-affiliated hospitals. We might refer them elsewhere or integrate their research into our portfolio.

YTO: Brigham’s version of the Connector is the Center for Clinical Investigation (CCI). We call ourselves the home of clinical research. We are the first stop if an investigator needs help or wants to learn how to implement clinical and translational research studies.

Investigators can use any or all of our resources, from something small to running the whole study. We can connect them with potential collaborators or just find somebody to read an EKG, if that’s what’s needed.

We have clinical space dedicated to research so we can accommodate patient visits. But just as importantly, investigators have access to vital services that are not patient-facing, such as data management, research coordination, and biostatistics support.

What do you wish investigators knew about Connector?

MB: People sometimes think that Connector is the CRC. While it is at some level, it’s also much more. Our strength lies in the collective experience of the many people who have already figured out how to design and conduct high-quality studies, who understand the steps for getting from point A to point B.

Our program director regularly meets with investigators to provide feedback on their grant applications, offer advice on how to find funding, or connect them with mentors.

All of the Connector sites have a role called a navigator. BIDMC navigators are experts in regulatory and operations. Depending on when they’re brought in, they can point investigators to resources or work through specific aspects of their study that might be challenging.

YTO: What I find with investigators is they don’t know what they don’t know. They may come to us with one question and not realize how many other things need to be considered before we can address that one question. Having that dialogue as early in the process as possible will help the investigator in the end.

Connector lets investigators tap the experience of a diverse clinical research team, whether it’s the nurses on the floor or a physician-investigator who’s done this before. It’s about knowing your patient population and what works with recruiting, right down to which time of day is easier for patients. It’s helping avoid the pitfalls that may come with being a newbie to research.

“Connector lets investigators tap the experience of a diverse clinical research team, whether it’s the nurses on the floor or a physician-investigator who’s done this before. It’s helping avoid the pitfalls that may come with being a newbie to research.”

One of the things I often say to early-career investigators or those testing a really novel idea is if you’re going to fail, fail fast. It’s okay to fail because you can use what you learn to make the next study better.

Give us an example of something you’re engaged in right now that illustrates how the Connector sites work.

YTO: One of our big pushes right now is to help investigators in the non-oncology space who are interested in conducting cell and gene therapy studies. We don’t want to recreate the wheel, so we’re connecting them to oncology physicians who have been doing these studies for a while. We’re bringing together players who aren’t otherwise talking to one another to figure out how current systems might be adapted for studies outside of oncology.

MB: We have a general medicine investigator who is running a diet intervention study for hypertension, focusing on enrolling Black Boston residents in areas with ‘food deserts’ –areas with grocery store scarcity. This investigator met with our Connector team early in his grant planning process. His studies are now funded, and he’s running them through our main Clinical Research Center at the Boston campus. But he is having a really hard time meeting his recruitment goals, so we are working with him to set up research support at our Bowdoin Street clinic.

Because of that collaboration, the clinic is being developed as a CRC satellite with a focus on community-engaged research that allows the local community to provide input on the studies conducted there. We are now working with other clinical groups to expand research at the site.

So by addressing a recruitment problem one investigator was having, we’re establishing a resource that other investigators can access to bring research to our community and potentially improve participant diversity in their studies.

Connector’s goal is to accelerate translational science, in line with the mission of Harvard Catalyst and other clinical and translational science programs funded by the National Center for Clinical and Translational Science (NCATS). From your perspective, is clinical research efficient enough?

MB: I think sometimes we have unrealistic expectations about efficiency. I honestly believe that we make things very efficient in our programs and within our institutions, but I don’t think clinical research itself is efficient, through no fault of our own.

It’s really difficult to run a study, especially if you think about the whole lifecycle. For an industry-initiated clinical trial for example, a sponsor wants you to have a budget, contract, IRB approval, and be ready to enroll your first patient within 60 days of being selected as a site, which is crazy. It’s not impossible but it’s highly unlikely, with so many steps and the complexity of various studies.

If you move too fast, you risk making mistakes. If you don’t think carefully about what’s involved in a study from a participant’s perspective, for example, you might meet your recruitment goals right away but have 60% who don’t meet inclusion/exclusion criteria at screening and 20% who didn’t realize they’d have to come in every day for the next six weeks. Those kinds of circumstances can be largely avoided with the right planning.

YTO: We definitely take some time on the front end to get all the information and tweak things where necessary to make sure the patient’s experience and the study team’s experience is positive and efficient. We want to make sure it’s done right, and that might take a little longer.

In the end I’d rather be confident that patients are safe and the data is accurate because we thought these things through up-front. That’s the time to do it, not when the patient shows up for the visit or the investigator sits down to write that paper with flawed data.

How does Connector affect the experience of patients involved in clinical research and why does that matter?

MB: Using a Clinical Research Center is hugely beneficial from the participant perspective. We had a study many years ago in which two people came in every month for seven years for the same study. They got to know each other, and they knew all our staff; they would even bake banana bread for the research center staff. I think if patients get to know the research center, that’s another mechanism for patient retention, particularly for longitudinal studies.

YTO: Agreed. Our nurses and clinical staff on the floor definitely make connections with the research participants, and they often learn something that could be valuable to the study team. Having that connection is key.

It’s not just the study team; it’s every member of the staff. It’s the person who smiles when they walk in the door, or the one who knows about their child or their cat and asks about it. That matters when you want a patient to come back again and again into the next month or year.

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CLINICAL RESEARCH ASSOCIATE, LEAD, DCRI

Durham, NC, US, 27710

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

MegaTrials CRA Lead (Job Code 2985)

Position Summary

Manage the development, coordination and implementation of clinical operations site management and clinical monitoring responsibilities for assigned projects with guidance, including trial-specific processes and systems, and daily supervision of the Mega Trial team responsible for site management and clinical monitoring in accordance with contractual agreements, department guidelines, SOPs, applicable international, federal and state regulations, and ICH guidelines.

** NOTE: This position may have an opportunity to work remotely.  All Duke University and Duke Health remote workers must reside in one of the following states or districts:  Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut, Indiana, Michigan, Maine, Ohio and New Hampshire

Core Job Responsibilities

• Provide leadership for the Mega Trial project team responsible for site management working in close collaboration with the project leader and other functional group leaders for execution of all monitoring services according to the project-specific scope of work:
• Define, assign, coordinate, oversee and assess utilization and productivity of team members’ daily in-house activities according to trial-specific scope of work, budget, and timelines.

Define, assign, coordinate, oversee and assess utilization and productivity of sub-contractors including independent contract CRAs, vendor or sponsor-provided CRAs, and other contracted services.

• Provide site management and clinical monitoring expertise, and leadership to assigned team. Provide advice and guidance to team members for assessment, resolution, and documentation of site and project issues.
• Identify resource needs and supervise team members’ work assignments, utilization and productivity.
• Direct and prioritize team efforts and assess overall team progress against project timelines and metrics. Develop performance standards for project team. Identify and notify project leader of emerging out of scope activities and study guidelines. Evaluate impact on resource needs, study processes and related documents.
• Review and approve team deliverables focusing on quality and timeliness of all activities within the defined scope of work.
• Oversight, and management of the Mega Trials SONAR report for each trial including ARO SONAR report when applicable.
• Coordinate the development, use and maintenance of study-specific processes, related documents, templates and other site management, communication, monitoring and regulatory tools.
• Define site selection and activation guidelines and related activities with the project leader, the principal investigator, and the sponsor. Approve sites in collaboration with the project leader and the sponsor.
• Train and supervise the team on trial-specific collection, review and approval of clinical trial documents and associated processes. Provide final approval of essential clinical trial documents.
• Observe for consistency in the conduct of the study and data collection according to the protocol and study objectives. Oversee identification of study and site issues and assist with resolution and documentation.
• Provide management of the development, implementation and maintenance of the clinical trial management system, related tracking tools and status reports.
• Apply best practices to site management clinical trials processes.
• Serve as key site management trial-team member to internal and external partners and to the project core team (project leader, principal investigator and other functional group key representatives).
• Collaborate with internal and external partners to develop trial-specific tools and processes, with guidance, for efficient management of tracking site and study status, enrollment, data collection, query resolution, and other trial activities.
• Provide input regarding the development of the CRF (data capture forms) design and completion instructions, site materials, query rules and resolution process, and related data tools and status reports.
• Facilitate communication between designated internal and external contacts (including contracts, clinical supplies, pharmacy, and sponsor) and study sites. Facilitate cross-functional team communication and proactive problem solving regarding study progress and trial issues with guidance.
• Manage production, review and approval of trial-related reports, including site status reports, site payments, regulatory status reports, trip reports, and expense reports for internal and external dissemination. Review reports for identification and resolution of study and site issues. Notify appropriate team members of findings and action plan.
• Organize, lead, and participate in study teleconferences and meetings with the trial team and other study partners
• Coordinate and oversee trial-specific training for project team members which may include therapeutic in-service, reference materials, investigator meeting, and team training, Provide and document regular feedback to individual team members. Maintain documentation, providing specific examples of performance issues.
• Recognize accomplishments of individual team members and the team as a whole.
• Manage all aspects of performance management including compiling and providing feedback to the team members’ annual performance evaluations, identifying strengths and areas for improvement using specific examples, and providing input for Individual Development Plans. Assist with development and delivery of performance reviews and work improvement plans.
• information exchange
• Attend appropriate Mega Trial leadership meetings, department meetings and organizational meetings. Encourage team members to attend appropriate team, department and educational meetings.
• Assist in the development, implementation and revision of processes, SOPs and standard forms.
• Oversee team dynamics to foster professional relationships.
• Maintain awareness of developments in clinical research regulations and therapeutic areas by reading related literature, attendance at professional meetings and research seminars.
• Encourage and support cross-functional and therapeutic information exchange.
• Participate in special assignments as requested by project leader.
• Interview job candidates and make hire recommendations for teams.
• Complete administrative activities accurately and in a timely manner, e.g., time tracking, attendance reports, training file.
• Encourage team to seek opportunities for personal development.
• Receive and review audit findings, develop action plan for audit response and provide input for formal audit response with guidance.
• Perform other related duties incidental to the work described herein

Education/Training

Bachelor’s degree preferable in clinical, health or life science.

Four years directly related experience in clinical trials research or 5 years four years directly related experience in clinical trials research.  Prefer 3 years directly related CRA or clinical trial management experience.

OR    AN    EQUIVALENT    COMBINATION    OF         RELEVANT                  EDUCATION         AND/OR EXPERIENCE

Required Knowledge, Skills and Abilities

A sterisk (*) or other notation to distinguish KSAs that are required at the time from those that are expected to be demonstrated at the conclusion of orientation, training, or probationary period for the position.

• * Strong technical spelling and grammar skills, including reviewing and proof reading of business documents and communications
• * Ability to write, speak, and present strategies clearly and concisely in a variety of communication settings and styles
• * Strong interpersonal skills, ability to establish and promote positive business relationships, customer service oriented
• Ability to collaborate with team members to achieve trial-specific goals within specified timelines
• Ability to collaborate with internal and external partners to achieve departmental and organizational goals
• Ability to lead others and foster teamwork; ability to manage, motivate and lead teams
• * Proficient computer skills including MS Office, Word, Excel and PowerPoint; able to learn and use computer applications
• Ability to train and coach site management and clinical monitoring team members
• Ability to direct and manage competing individual and team activities to meet trial objectives, timelines and budget
• * Ability to use critical thinking skills to effectively solve problems and use conceptual thinking to anticipate impact of decisions
• * Strong knowledge of medical terminology
• Understanding of scientific application to clinical trials research
• * Technical knowledge and skills for monitoring procedures and practices
• Knowledge of clinical research trial operations
• * Strong knowledge of FDA regulations, ICH guidelines, and Good Clinical Practices and their application to clinical trials
• Understanding of departmental SOPs and systems
• *Ability to travel 25%, some for consecutive nights

Registration, Certification or Licensure

• Valid U.S. driver’s license
• ACRP CCRC or CCRA, or SoCRA CCRP is a plus

Working Conditions

• Extensive use of telephone and electronic mail systems
• Extensive repetitive keyboarding motions
• Extensive focusing on computer monitor for long periods of time
• Occasional lifting and moving of heavy business documents
• Occasional travel with a laptop computer and heavy business documents

Bachelor’s degree pre ferable in clinical, health or life science.

Four years directly related experience in clinical trials research or 5 years four years directly related experie nce in clinical trials research.  Prefer 3 yea rs directly related CRA or clinical trial management experience.

OR    AN    EQUIVALENT    COMBINATION    OF    RELEVANT          EDUCATION                AND/OR EXPER IENCE

·     * Strong technical spelling and grammar skills, including revi ewing and proof reading of business documents and communications

·     * Ability to write,< span>speak, and present s trategies clearly and concisely in a variety of commu nication settings and styles

·     * Strong interpersonal skills, abili ty to establish and promote positive business relationships , customer service oriented

·     Ability to collaborate with team memb ers to achieve trial-specific goals within specified timeli nes

Minimum Qualifications

Work requires graduation from an accredited degree program providing 1. Completion of an allied health degree (e.g., Respiratory Therapy, clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus four years of healthcare experience; or one of the following equivalents: Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of six years healthcare experience; or 2.Completion of a master's degree in Public Health, Health Administration or a related area with three years directly related clinical trials research experience; or 3. Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research; or 4. Completion of a bachelor's degree plus a minimum of five years closely related research experience. **State of North Carolina license may be required.**

None required beyond that described above OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Nearest Major Market: Durham Nearest Secondary Market: Raleigh

Duke is an Affirmative Action / Equal Opportunity Employer committed to providing employment opportunity without regard to an individual’s age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status. Read more about Duke’s commitment to affirmative action and nondiscrimination at hr.duke.edu/eeo.

Clinical Research Program Manager

• University of Pennsylvania
• Philadelphia, PA, USA
• Aug 18, 2024

Job Description

• Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
• Tuition : Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
• Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
• Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
• Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.

Application Details (to apply use the Apply Now button below.)

How to Apply: Please click the "Apply Now" button below or visit: https://wd1.myworkdaysite.com/recruiting/upenn/careers-at-penn

Jobs at the University of Pennsylvania. When inquiring or applying for positions within the University of Pennsylvania, please also reference AcademicCareers.com

Applicants with dual-career considerations can find university jobs such as professor jobs, dean jobs, chair / department head jobs, and other faculty jobs and professional and administrative staff employment opportunities at the University of Pennsylvania and at other institutions of higher education in the region on www.AcademicCareers.com To receive email alerts when new jobs at the University of Pennsylvania are posted, job seekers can sign up at new job openings at the University of Pennsylvania.

A Great Place to Work

Penn's innovative schools, centers, and divisions offer a vast array of positions in a broad range of fields. Penn is the largest private employer in Philadelphia. Here you can find new opportunities as your career develops—from your first job out of school to your first leadership role, and all points in between. You can discover new work settings as your goals evolve, and even change professions.

We’re famous for research and education, but did you know Penn also offers positions in areas such as financial management, hospitality, transportation, real estate development, investments, public safety, fundraising, marketing, communications, and information technology (IT)?

Penn is a leading employer in key fields. We are regularly ranked as one of the best places to work in IT, and our Office of Development and Alumni Relations is one of the premier organizations in the industry.

If you have a passion for excellence in education, research, or service to the community, Penn is the right choice for any point in your professional journey.

University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

When inquiring or applying for positions within the University of Pennsylvania, please also reference AcademicCareers.com

Neuroscience Clinical Development Experts

Cognitive Research Corporation (CRC) is a full-service CRO with deep expertise in CNS/Neuro drug development from Phase I to Phase IV. Our Team’s neuro-focused experience and lessons learned allows us to focus on clinical trial operational excellence that provides our Sponsors improved patient experiences, accelerated timelines, reduced costs, quality-driven data, and milestone adherence for better outcomes and a shared vision. 

Connect with CRC

Leading Phase I-IV Neuroscience-specialty CRO

Cognitive Research Corporation (CRC) is a privately held, full-service contract research organization that specializes in Neuroscience product development for pharmaceutical, nutraceutical, biotechnology and medical device companies. We combine a deep scientific understanding of the Neuroscience space with decades of operational experience in managing clinical trials around the globe. It is personal to CRC, and it is personal to every member of our team. We Change Lives.

Our scientific expertise has resulted in more than 200+ clinical trials across 30+ INDs and 14 NDA submissions and approvals. Our focused, Neuroscience expertise has allowed us to build strong relationships with the leading Neuro/CNS research sites to provide the strongest candidates to complete our programs. Our partner network includes 300+ clinical research sites that are fully equipped and trained to conduct CRC clinical trials.

Our mission is to continue to be the most trusted, customer-centric, Neuroscience-focused clinical services company; Our Vision, a world where most of today’s cognitive health challenges can be effectively treated or even cured so that patients have a chance at a better quality of life.

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Olympian Clinical Research

Clinical Research Management (Regulatory Science), MS

• Program description
• At a glance
• Degree requirements
• Admission requirements
• Tuition information
• Attend online
• Application deadlines
• Career opportunities
• Professional licensure
• Contact information

Medical Device Regulation, Quality Assurance, Regulatory Affairs, Regulatory Science, Regulatory Writing

Are you ready to take your career in clinical research to the next level? This program is the perfect opportunity to advance your expertise. Open doors to exciting new possibilities in the dynamic field of clinical research management with a focus in regulatory science.

Regulatory affairs ensure that new products meet the requirements and standards set by regulatory authorities, and regulatory science addresses the safety, efficacy, quality and regulation of new medical products, diagnostics and treatments. This master's program aligns regulations and national competencies throughout the life cycle of medical products. With a master's degree in clinical research management and a focus on regulatory science, graduates can advance medical care and treatment while ensuring that new discoveries adhere to rules and regulations that keep patients safe.

The regulatory science concentration of this program provides students with a balance of skills in clinical research management and regulatory affairs and sciences. Coursework in this rigorous program includes regulatory writing techniques, quality assurance, medical devices and drugs, and pharmaceutical safety and risk management, ethical standards and regulation, in addition to clinical trial management.

This program meets the needs of professional adult learners and provides the flexibility of online courses, allowing for enrollment five times per year. Students can complete the program on a part-time basis, enabling them to continue to work while earning their degree. The program has the distinction of being the first clinical research graduate degree to receive accreditation from the Commission on Accreditation of Allied Health Education Programs. The CAAHEP is the largest programmatic accreditor in the health sciences field and is recognized by the Council for Higher Education Accreditation in the U.S. and internationally.

• College/school: Edson College of Nursing and Health Innovation
• Location: Online
• STEM-OPT extension eligible: No

33 credit hours including the required capstone course (HCR 566)

Required Core (18 credit hours) HCR 551 Clinical Research Monitoring (3) HCR 561 Responsible Conduct of Clinical Research (3) HCR 562 Clinical Research Data Management and Technology Implementation (3) HCR 563 Fundamentals of Regulatory Affairs (3) HCR 565 Clinical Research Operations (3) HCR 574 Scientific and Research Review Boards (3)

Concentration (12 credit hours) HCR 553 Quality Assurance and Clinical Research (3) HCR 555 Pharmaceutical Safety and Risk Management (3) HCR 557 Clinical Research Design and Methods (3) HCR 564 Global Regulatory Affairs Leadership (3) HCR 567 Research Management and Contemporary Research Topics (3) HCR 578 Legal Aspects of Clinical Research (3) HCR 579 Translational Research in Drug Discovery and Development (3)

Culminating Experience (3 credit hours) HCR 566 Clinical Research Management Capstone (3)

Applicants must fulfill the requirements of both the Graduate College and the Edson College of Nursing and Health Innovation.

Applicants are eligible to apply to the program if they have earned a bachelor's or master's degree.

Applicants must have a minimum cumulative GPA of 3.00 (scale is 4.00 = "A") in the last 60 credit hours or 90 quarter hours of their first bachelor's degree program or a minimum cumulative GPA of 3.00 (scale is 4.00 = "A") in an applicable master's degree program.

All applicants must submit:

• graduate admission application and application fee
• official transcripts
• resume or curriculum vitae
• three online references
• proof of English proficiency

Additional Application Information An applicant whose native language is not English must provide proof of English proficiency regardless of their current residency.

The applicant must have six months of full-time, related clinical research work or internship experience as described in a resume or curriculum vitae. Applicants without six months of experience are required to complete the research foundation courses provided through the program prior to enrollment in any courses.

The online references should be from colleagues, supervisors or other professional contacts and should attest to the applicant's academic and leadership experiences.

Courses or a background in anatomy, physiology and medical terminology are recommended.

ASU offers this program in an online format with multiple enrollment sessions throughout the year. Applicants may view the program’s ASU Online page for program descriptions and to request more information.

Graduates with an MS in clinical research management with a focus on regulatory science have a variety of career opportunities to explore. Career examples include:

• clinical research associate
• project manager
• quality control specialist
• regulatory affairs manager
• regulatory affairs specialist

ASU programs that may lead to professional licensure or certification are intended to prepare students for potential licensure or certification in Arizona. Completion of an ASU program may not meet educational requirements for licensure or certification in another state. For more information, students should visit the ASU professional licensure webpage.

Edson College of Nursing and Health Innovation | MERCC 250 [email protected] 602-496-0937

• Success Stories

Clinical Research Associate (CRA)

by | Mar 22, 2018

Accell Clinical Research is looking for a determined and motivated Clinical Research Associate (CRA) ready to work in St. Petersburg Clinical Headquarters and to travel across Russia, CIS, and Eastern Europe, as well as for local CRAs within Eastern Europe and CIS.

CRA is responsible for monitoring the performance of all study sites from A to Z and providing a link between a project team and investigators. CRA’s primary focus is expected to be on meticulous site management via executing all types of site visits, monitoring sites’ deliverables, IMP, and all related items supply. Other responsibilities include, but are not limited, to :

• identification of investigators and site selection; conducting pre-study visits for the qualification of investigators and sites; compiling regulatory packages;
• conducting all types of initiation, monitoring, close-out, and audit visit attendance;
• completing monitoring trip reports, reports study progress, escalating issues related to the protocol according to ACCELL and/or Sponsor timelines and quality;
• conducting on-site investigational product and study supply accountability and management;
• facilitating communication between an Investigator and the Sponsor;
• preparing and negotiating study budgets for the site, investigator, and study vendors;
• preparing, organizing, and overseeing the site, investigator, and vendor payments;
• managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.

We are looking for a professional with:

• a solid knowledge of written and spoken English (upper-intermediate level or higher),
• a university degree in the health-related field (Medical Doctor degree would be a plus),
• strong work ethics and sound management skills, and
• at least 1 year of clinical research work experience.

The person applying should be willing to actively participate in the corporate life of the company (including training sessions and other activities) and to travel a lot (approximately 50% of the total working time).

Please send your application request and your Curriculum Vitae in English to Philip Sigalov, MD, Ph.D. (Director of Clinical Operations) at [email protected] .

Updated on: January 28, 2020.

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