Master of Science in Regulatory and Clinical Research Management (RCRM)
The health care field is fast-paced and changing. Regulatory professionals work in companies and agencies to ensure products are safe and effective, and the design, manufacturing, and testing of products comply with regulations and standards. Regis College’s Master of Science Degree in Regulatory and Clinical Research Management is designed to help students navigate the increasingly complex areas of drug, device and biologics regulatory affairs, health economics and reimbursement, health policy and development, and clinical trial management.
Master of Science in Regulatory and Clinical Research Management
The Master of Science Degree in Regulatory and Clinical Research Management is designed for candidates with baccalaureate degrees in the sciences or who are currently working in the regulatory or clinical field. Candidates for this program are those men and women who wish to advance in professional training or seek a career in the biotechnology, device, and pharmaceutical industries or academic research environment.
This program allows the student to focus on one of two specialty tracks, product regulation or clinical research management. Electives allow the student to take the courses for both tracks or to pursue other areas of interest, such as health economics, health policy, or quality systems and risk management.
Our students acquire skills, knowledge, and field experience that provide the necessary credentials to enhance or enter careers in regulatory affairs, clinical affairs, and health policy.
Graduate Certificates in Product Regulation or Clinical Research may be obtained with the completion of four courses within the subject area.
Candidates with a bachelor's degree in science who seek the MS degree in Regulatory & Clinical Research Management complete 11 courses of study (33 credits), which include six core courses including a field experience project, three additional courses for the candidate’s specialty track, and two elective courses. The program is flexible to fit the schedule of working professionals. Evening and weekend courses are offered. Virtual classroom technology allows even more flexibility. The program can be completed in fifteen months by candidates who choose to take three courses during most terms. Most students choose to take fewer courses, earning their degree in two to three years.
Two non-Regis College graduate courses, relevant to the program, may be transferred from other accredited graduate schools with the approval of the program director.
- RA 601 Overview of the Health Product Industry
- RA 602A Overview of Health Product Regulation
- HP 600 Biostatistics
- HP 601 Health Ethics and Law
- HP 603 advanced Writing for the Health Professions
- RA 605 Field Experience (usually taken after completion of the track requirements)
Completion of a Specialty Track
Product Regulation Specialty Track Requirements
- RA 603A Pharmaceutical Product Regulation
- RA 604A Medical Device Regulation
- RA 615 Risk Management and Quality Systems
Clinical Research Specialty Track Requirements
- RA 608 Clinical Research Methods
- RA 609 Clinical Trial Management
- RA 616 Project Management
A student can take as electives courses from the specialty track not selected.
Other electives include
- HP 622 Economics of Health Care
- NU 618 Health Policy
- NU 620 Clinical Pharmacology
- Other graduate Communications courses (CO 6xx)
- Other graduate Health Profession courses (HP 6xx)
One credit courses
- RA 630 Combination Products
- RA 631 Personalized Medicine
- RA 633 Chinese Medical Device Regulation
(Students currently enrolled in the RCRM program will be charged program tuition for 1 credit. Non-degree seeking students enrolled in the one credit courses will be charged $1000/credit. The one credit courses do not satisfy the special student option of taking two courses prior to enrolling in a program).
Other graduate courses may be taken as electives with the consent of the Regulatory & Clinical Research Management program director, Dr. Joel Feinblatt, email@example.com.