Saturdays, February 17 to March 16, 2024
9:00 AM – 3:30 PM
A great course for people new to the field of clinical research. Gain a thorough understanding of the drug development process, clinical research conduct, compliance, regulation, data, budgets, and key roles in the industry.
Each session is taught by an instructor currently working in that topic area.
They work at organizations including:
Boston Children’s Hospital • Centrexion Therapeutics • Deciphera Pharmaceuticals • EMD Serono, Inc. • EndPointe Clinical Resources, Inc • Epizyme • Harvard T.H. Chan School of Public Health • ImmunoGen, Inc., • Johnson & Johnson (Janssen Oncology) • Medidata • Merck • Propel Careers • QurAlis • Takeda Pharmaceuticals International Co.
This course meets for 10, three hour sessions:
Session 1: Overview of the Clinical Research Process
Session 2: Clinical Research Personnel, Service Providers, and the Site Selection Process
Session 3: Human Subject Protections and Regulatory Oversight
Session 4: Clinical Trial Conduct, Monitoring and Record Keeping
Session 5: Components of Ethical Evaluation of Human Research and Privacy Considerations
Session 6: Recruitment and Retention, Drug Compliance and Accountability, and Study Close-Out Procedures
Session 7: Pharmacovigilance in Drug/Device Development
Session 8: Audits & Inspections: Ensuring Clinical Research Quality
Session 9: The Role of Data Management in Clinical Research
Session 10: Study Budgets and Contracts: Evaluation and Negotiation
Feedback from recent students
“I just want to thank you again for providing this amazing content! Every teacher was outstanding. I feel so lucky I was able to do this from the West Coast, thanks to the video platform.”
“This program was very informative and I believe it is definitely most effective when taking all 3 parts. Each section built up on the section before it and it all came together with the last section delivered by Judson and Lauren. The third section really pulled it all together for me and was definitely when I had my “ah ha moment”. Until then I was still quite concerned that I was struggling to narrow down what area I would like to pursue and if I was going to be able to find an area that would be a good fit without having a college degree.”