Graduate Certificate Program in Research Management and Compliance

Overview

The one-year Graduate Certificate Program in Research Management and Compliance (ReMC) is designed to provide students with focused training on central issues related to an effective research enterprise. Principal investigators are busy with mentoring trainees, writing and reviewing grants and writing papers as well as tending to other issues that require the attention of people with their expertise. Being able to hire professional research assistants who are familiar with the composition and requirements of writing IRB and IACUUC applications (BSBT 6802 The Regulatory Environment of Life Science Innovation), basic components of tech transfer and innovation (BSBT 6801 Biomedical Entrepreneurship), responsible conduct of research (BSBT 6065), as well as professional project management (BSBT 6061), should be very helpful for their research enterprise. Knowledge in statistics for biomedical sciences (BSBT 6067) should be valuable for data analyses. Depending on the students’ prior training, they will also have to enroll in either training in scientific writing or in R programming. These knowledge areas and skills should aid certificate holders to obtain positions as professional research assistants inside and outside academia.

Required Courses:

Course Number	Course Title	Credits	Semester
BSBT 6065	Case Studies in Responsible Conduct of Research (RCR)	1	Spring
BSBT 6802	Legal and Regulatory Environment of Life Science Innovation - Drug Discovery	1.5	Summer and Fall
BSBT 6803	Legal and Regulatory Environment of Life Science Innovation - Medical Devices	1.5	Fall
BSBT 6061	Project Management	2	Fall or Spring
BSBT 6067	Statistics for Biomedical Sciences	2	Spring
BSBT 6071	R Programming or BSBT 6113 Data Science with R or BSBT 6064 Scientific Writing (prior discussion with program director required)	1	Spring
BSBT 6801	Biomedical Entrepreneurship	3	Spring

Students who can demonstrate proficiency in any of the subject areas of the required courses can propose a course replacement.

Learning Objectives:

1. Employ basic tools of R programming.
2. Classify data and use statistical tools to test hypotheses.
3. Explain the central components of successful business strategies in biotechnology and create a business plan.
4. Explain the scientific implications and issues of quality control and regulatory affairs related to drug development and create a project plan.
5. Recognize challenges in biomedical sciences and biotechnology in real-world settings and contribute to their solutions and advancements.
6. Understand and apply appropriate forms of management that are central for the successful completion of a project.