Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
M.Sc. Clinical Research or Master of Science in Clinical Research is very detailed course with all clinical research overview and also including pharmaceutical, drug development and regulatory aspects of clinical trials. In this course we studies in depth the safety and effectiveness of medications which are meant for human use and this course should be opted if an individual wants to be a part of this research-based industry.
M.Sc in clinical research is a 2 years full time course with all subjects of clinical research overview including project management.
Job Profiles after M.Sc. Clinical Research –
- Clinical Research Associate
- Clinical Research Coordinator
- Clinical Analyst
- Clinical Research Investigator
- Study Coordinator Manager
- Associate Study Coordinator Manager
- Data Manager/Biostatistician
- Clinical Trials Auditor
- Clinical Project Manager
- Clinical Research Manager
- Clinical Data Coordinator
- Clinical Data Associate
- Clinical Data Validator
- Clinical Data Reviewer
- SAS Programmer
- Business Development
- Clinical Development
- Drug Safety Associate
- Product Safety Monitor
- Regulatory Affairs Associate
- Scientific Medical Writer
- Medical Writer
- QA/QC Associate
One can apply in the following fields, depending upon their area of interest:
- CRO(Contract Research Organizations)
- Medical Device Companies
- PRO (Patient Recruitment Organizations)
- Medical writing
- Central lab
- Logistics and courier services
- Auditing of clinical trials
- Pharmaceutical Industries
- Clinical data management
- Regulatory affairs
- Research sites
- Government Agencies
The scope of work of Clinical Research Professionals:
- Clinical Research professionals supervise designing and writing of protocols, case report forms, and informed consent forms for clinical trials. They make sure that case report forms are reviewed timely and submitted to the data management group.
- Understand evolving regulatory processes, standards and practices of ICH GCP in the conduct of different therapeutic trials and Ensure that the trial progress is recorded, conducted and reported in accordance with Standard Operating Procedures (SOPs), ICH GCP & Protocol Specified guidelines, Good Clinical Practice (GCP), and the relevant Regulatory Requirements.
- Perform Ethics Committee Submission & Approval, coordinating Audit visits and Regulatory submissions.
- Perform Site management; Management of site staff & patients, patient recruitment & retention.
- Carrying out clinical study feasibility, handling trial documentation and trial logistics at site.
When you have completed your course, you can expect an MSc clinical research starting salary of close to 5 lakhs per annum. Based on your years of experience, the salary offer can go even higher. For students who have completed the master’s degree in clinical research administration and are pursuing careers in clinical research a Doctor of Philosophy (Ph.D.) in Clinical Research is also available.