Building a Strong Foundation in Clinical Research and Offering Hands-On Experience
Clinical Research Professionals are essential to the study of new drugs and devices leading to improved medical outcomes for patients. Our curriculum aligns with the Joint Task Force for Clinical Competency and is carefully designed to ensure that all of our students will graduate with these core competencies. No Clinical Experience Required!
Why Study Clinical Research Management at SHP?
A master’s degree in clinical research provides graduates with clinical research professional competencies, skills and knowledge. The CRM program will prepare you to work in various settings, including private practice, cooperative research groups, public and private academic institutions, pharmaceuticals, medical device and biotechnology companies.
$110,495
* average salary of a Clinical Research Management graduate.
* U.S. Bureau of Labor Statistics
Program Highlights
- Our graduates are highly marketable and gain positions in the clinical research space.
- Program follows a hybrid model with didactic courses offered through our Learning Management System and are supported with synchronous and asynchronous sessions providing flexibility for working adults.
- Courses are composed of blended activities carefully designed to deliver challenging and engaging content taught by Rutgers faculty with subject matter expertise in clinical research from pharmaceutical companies, CRO and government agencies.
- The cohort model groups students together for an enhanced educational experience which fosters academic success by creating a supportive learning environment to real world experiences in clinical research through team science.
- Completion of the MS degree is a substitute for Clinical Research Associate or Clinical Research Coordinator work experience towards your CCRA or CCRC eligibility requirements
What is a Clinical Research Managemment Professional?
CRM professionals are essential to the study of new drugs and devices. The clinical research industry relies on these professionals who are specially trained to navigate the complex world of medical product development to ensure safe and effective treatments reach patients.
Program Overview
The Master of Science in Clinical Research Management is a 36-credit multi-disciplinary curriculum offered in a hybrid model by the Rutgers School of Health Professions. It builds a broad and well-rounded foundation for the clinical research professional through synchronous and asynchronous curriculum.
Our curriculum aligns with the Joint Task Force for Clinical Competency and is carefully designed to ensure that all of its students will graduate with these core competencies. By offering a solidified core, students will benefit from a focused, targeted and relevant body of knowledge upon which the student can depend on to support their journey towards achieving career advancement.
Our elective courses allow students to explore areas which will build on the introductory and reinforcing concepts covered in the core courses and will lead to a mastery of specific concepts.
Clinical Research Management program value:
- Completion of the M.S. degree is a substitute for Clinical Research Associate or Clinical Research Coordinator work experience towards your CCRA or CCRC eligibility requirements
- Students are able to receive a 25% discount on the SHP Phlebotomy and Specimen Accessioning Certificate’s tuition
- Three tracks to choose from: Clinical Research Management, Drug Safety and Pharmacovigilance, and Academic Clinical Research Management
To learn more, email crmprogram@shp.rutgers.edu.
Curriculum
Our goal is to prepare competent entry level and advanced level Clinical Research Professionals in the cognitive, psychomotor and affective learning domains through a competency-based framework of the following domains;
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One of three tracks may be selected:
Clinical Research Management
The core program covers the theory and practice of research methods, statistics, regulatory and legal frameworks for clinical investigation, drug development, clinical research operations, project management, leadership skills, disease process, and regulatory writing. Students take additional courses defining their area of specialization in patient engagement, advertising and labeling, medical devices, international regulatory affairs, medical affairs, or clinical data management. This track is designed for the clinical researcher who has some experience working in the pharmaceutical industry or academic medical center. However, novice individuals may also consider this option.
- Design a clinical and translational study incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization, safety management as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints
- Conduct informed consent, maintain privacy, and apply principles of human subject protections at all stages in drug and device development. Describe how historical events with regards to subject protection informed changes in the code of federal regulations and other regulatory documents.
- Plan and implement trial related activities in accordance with regulatory and legislative guidances to ensure safety, efficacy and quality in a clinical trial
- Apply Good Clinical Practice with regards to study conduct and management, safety profile management, and the control and handling of investigational products to national and global trials.
- Construct appropriate communications as they pertain to IRB application, FDA and global regulatory agencies, budget negotiations, and other filing opportunities.
- Explain and interpret the flow of study data through electronic data capture programs, and participate in data correction and queries.
- Implement leadership and project management strategies to solving ethical and professional conflicts associated with the conduct of clinical research
Drug Safety and Pharmacovigilance
This track focuses on drug safety basics and regulations, risk management, and signal detection, as well as the core elements of theory and practice of research methods, regulatory requirements of clinical investigations, disease process and pharmacology. It is designed for the drug safety professional who has minimal knowledge in the pharmacovigilance area.
- Design a clinical and translational study incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization safety management, as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints;
- Utilize the principles of pharmacoepidemiology, pharmacogenomics and other drug safety science to analyze potential safety issues and understand the patient population and the risks in the drug development process
- Summarize the specific drug safety function and processes in line with regulatory and legislative framework that ensures safety and quality though the various phases that must be followed in order for the regulatory authority to approve the marketing authorization for a medical product
- Implement drug safety and pharmacovigilance operations as it relates to US and EMA rules, regulations and initiatives governing both safety reporting (ICSR and aggregate reports) and processing data from clinical trials, and post-marketing environments including CIOMS and ICH guidelines.
- Develop and maintain Pharmacovigilance System Master Files, Safety Management Plans and Safety Data Exchange Agreements across clinical study programs and post marketing activities.
- Identify the data sources, data capture, data assessment (seriousness; labeledness/expectedness and causality), data management practices, database tools and MedDRA dictionary for narrative preparation and analysis of clinical and post-marketing safety data
- Perform risk identification (signal detection) and characterize identified risks, potential risks based on signal analysis to develop a risk management plan
- Analyze data obtained from the different Risk Management Tools such as RMPS and REMS
- Identify and implement the practice of leadership and project management through the role of key drug safety professionals with the drug safety function associated with the conduct of clinical research, product strategy and responding to regulatory authority inquiries.
- Discuss the various elements of communication for a cohesive quality management system including effectively preparing and conducting audits and inspections across the site and sponsor, health authorities and contract research organizations as well as within the site through the understanding of multidisciplinary teamwork skills necessary for collecting and querying safety data in a clinical trial
Academic Clinical Research Management
This track is especially designed for students with no clinical research or pharmaceutical experience who would like to participate in clinical research at an Academic Medical Center (AMC) functioning as a “study coordinator.” It covers the theory and application of research methods, basic statistics, regulatory and legal governances over clinical trials and the conduct of clinical research performed at research intensive institutions. Pathophysiology and pharmacological outcomes as well as project management, prepare the novice practitioner to become a Clinical Research Coordinator specializing in clinical operations at AMCs.
- Design a clinical and translational stu dy incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization, safety management as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints.
- Apply an understanding of the history of ethical and cultural issues, informed consent, inclusion and exclusion criteria in regard to human subject protection and privacy as well as safety as it relates to the drug development process.
- Implement regulatory and legislative guidances and regulations that ensure safety, efficacy and quality for regulatory authority approval for the marketing authorization for a medical product.
- Identify red flags indicating ADRs may be present.
- Conduct consenting processes across a variety of research participants.
- Identify and explain the specific procedural, financial and regulatory documentation including IRBS, clinical trial agreements, and regulatory inspections of site personnel related to the conduct of a clinical trial.
- Describe how data sets the stage as a critical role in a clinical trial including electronic data capture, the importance of information technology in data collection, capture, management, and queries.
- Identify and implement the project management that are associated with the conduct of clinical research and project strategy
- Develop a patient recruitment plan
The curriculum for the three tracks can be found through the following links:
- Full-Time Fall 2-Year for Clinical Research Management or Clinical Research or Clinical Research Management-Drug Safety and Pharmacovigilance
- Part-Time- Fall 3-Year for Clinical Research Management or Clinical Research Management-Drug Safety and Pharmacovigilance
- Part-Time Spring 3-Year for MS Clinical Research Management or Clinical Research Management-Drug Safety and Pharmacovigilance
- Full-Time Fall 16-Month for Academic Clinical Research for MS Clinical Research Management
Additional Information
| Track | Clinical Research Management and CRM Drug Safety and Pharmacovigilance Track |
Academic Clinical Research Management |
|---|---|---|
| Experiential Training | Culminates with a Capstone project involving an experiential training opportunity at a clinical research site or a bio-pharma company. Students may elect to take “Scientific Writing for Translation of Medicine” instead of Capstone and prepare a publishable manuscript. | Experiential training is threaded throughout this track and may culminate with an offer to work in one of our clinical research units. |
| Length till Completion | In 2 years as a full-time student OR in 3 years as a part-time student. | ONLY offered full-time, with curriculum extending over 4 semesters. |
| Form of Education | Didactic courses are taught online and predominately asynchronously. Capstone project has the option to be remote or in-person. | Courses are predominately taught online. Three courses require in-person attendance. |
| Admission Available | Fall OR Spring.
Note: Fall Admission offers full- and part-time option. Spring Admission ONLY offers part-time. |
Fall ONLY. |
Admission Criteria
Students may choose either a 2-year plan or a 3-year plan for Clinical Research Management and Drug Safety and Pharmacovigilance, or a 16 month plan for the Academic Clinical Research track.
- Bachelor’s degree or higher with a minimum GPA of 3.0. The Clinical Research Management Track is designed for the clinical researcher who has some experience working in the pharmaceutical industry or academic medical center, while the Academic Clinical Research Track is designed for individuals with no previous clinical research experience. For the Drug Safety Track, a clinical background in medicine, nursing, pharmacy, or allied health, is suggested but not require
- Complete application form online and select either Clinical Research Management, Clinical Research Management- Drug Safety and Pharmacovigilance or Academic Clinical Research Management
- Two letters of recommendation from individuals who can assess your professional ability and potential for successful graduate studies. Enter email address of individual you are requesting the recommendation from in the online application to request recommendations from either a professional or academic source. If a formal letter is submitted, it should be on letterhead representing the recommender, dated and signed by the individuals submitting the recommendation letter.
- A 300-400-word statement about your short-term and long-term career goals.
- $70.00 application fee (non-refundable)
- Official transcript from highest degree attained. Mail directly to: Rutgers School of Health Professions Office of Enrollment Services, 65 Bergen Street, Room 149, Newark, NJ 07101
- Resume indicating employment and educational background should be attached as supporting document to your online application.
- Credential Evaluation: Applicants who have attended an educational institution in a foreign country are required to have their transcript(s) evaluated by a transcript evaluation service. WES is preferred but please visit http://www.naces.org/members.htmfor other acceptable agencies. Official reports are to be mailed directly to Rutgers School of Health Professions Office of Enrollment Services, 65 Bergen Street, Room 149, Newark, NJ 07101.
- A passing TOEFL test score (min. of 79 Internet based) is required for individuals who have a foreign degree from countries where English is not an official language. Official electronic TOEFL reports should be sent from vendor directly to Rutgers School of Health Professions Office of Enrollment Services, 65 Bergen Street, Room 149, Newark, NJ 07101
The Graduate Records Examination (GRE) is not required.
We recommend that you contact the Program at crmprogram@shp.rutgers.edu prior to applying to our program so we can answer any questions you may have.
SHP Tuition and Fees
Our tuition is credit based at a rate of $1009 for NJ residents and $1050 for non-NJ residents. There is an initial general service administrative fee of
$50. In addition, the school fees are a program fee, technology fee, and distance/hybrid program fee. For ACRM track, there is also a criminal
background check application fee.
For Tuition and Fees, please see the Graduate Tuition and Fees.
(Scroll down to 2023-2024 Rutgers Health Tuition and Fee Rates and click on School of Health Professions)
A small scholarship (Award of Excellence) is available for a select number of students attending the full-time Academic Clinical Research Management track.
FAQs
It is a 36-credit curriculum which offers a broad and well-rounded foundation for the clinical research professional to assist with clinical drug and device studies. The program offers three areas of specialization: Clinical Research Management; Drug Safety and Pharmacovigilance; and Academic Clinical Research
This program educates individuals to become Clinical Research Professionals who possess a thorough understanding of drug development.
The CRM program will prepare you to work in various settings, including private practice; cooperative research groups; public and private academic institutions; pharmaceutical, device, and biotechnology companies; Clinical Research Organizations (CROs); Site Management Organizations (SMOs); independent research and development organizations; and organizations otherwise involved in the management of clinical trials.
- Bachelor’s degree or higher with a minimum GPA of 3.0
- Two letters of recommendation.
- Application including a 300-400-word statement acknowledging your short-term and long-term career goals
- Official transcript from highest degree attained
- Resume indicating employment and educational background
- Credential evaluation if attended a university outside the US
- TOEFL exam for individuals who have a foreign degree from countries where English is not the official language
You may apply online through the MS application .
We recommend you contact the program director prior to starting the application process at CRMProgram@shp.rutgers.edu.
Overall, the CRM program is considered hybrid, however, the Clinical Research Management (CRM) and CRM-Drug Safety and Pharmacovigilance tracks are didactic courses taught predominately on-line and asynchronously. The Capstone project (field mentorship) has the option to be remote or in-person. The Academic Clinical Research Management courses are predominately taught online. Two courses require in-person attendance at a clinical research site.
$50. In addition, the school fees are a program fee, technology fee, and distance/hybrid program fee. For ACRM track, there is also a criminal
background check application fee.
For Tuition and Fees, please see the Graduate Tuition and Fees table.
(Scroll down to RBHS Tuition and Fee Rates and click on School of Health Professions)
A small scholarship (Award of Excellence) is available for a select number of students attending the full-time Academic Clinical Research Management track.
Yes, it is available for Master’s Degree student. Contact the Rutgers Student Financial Aid Office at 973-972-4376 or click here.
Yes, scholarships are available for master’s degree Students. Contact the Rutgers Student Financial Aid Office or call 973-972-4376 or Rutgers SHP scholarships can be found here.
A small scholarship (Award of Excellence) is available for a select number of students attending the full-time Academic Clinical Research Management track.
Our didactic courses are supported through a learning management system. Courses require ongoing participation and interaction with the instructor and other students in the class in a synchronous and asynchronous manner.
This active participation is achieved in many different ways depending on the course. In general these courses require readings from a textbook, journal articles, or visits to websites. Online discussions (Discussion Forums) with the instructor and students assist in the interpretation, synthesis, and analysis of the readings, while the written assignments are generally structured to assist in applying the information to one’s practice. Our courses include video clips, lecture handouts, and video-streaming. Emphasis is placed on developing a conceptual framework supported by the evidence in the literature.
In general, participation in each course entails approximately 10-12 hours of work per week. This includes time spent reviewing lecture content, participation in discussions, written assignments and assigned readings. Time spent writing papers and/or studying and taking exams are included in this estimate.
No. Even though this program is considered hybrid, there are no on-campus classroom courses. The majority of the courses are remote. The few courses that require/may have face-to-face time are at the field mentorship location. Therefore, this program is not able to provide any student Visa or (Green Card) support/sponsorship.
