Job Description
Key Responsibilities:
- Learn to draft protocols, amendments, and study schedules based on client or study outline requirements.
- Assist in reviewing study compliance with protocols, SOPs, and regulatory guidelines.
- Prepare study schedules in coordination with the Study Director (SD) or Principal Investigator (PI) and communicate work plans to lab teams.
- Participate in pre-initiation meetings and other study-related discussions.
- Track study progress and update Clinical Management Systems (CMS) with accurate schedules.
- Serve as a primary contact for internal teams and clients (as applicable).
- Maintain well-organized study files, including protocols, schedules, and correspondence.
- Assist in monitoring in-life and analytical phases of studies, ensuring adherence to guidelines.
- Support report preparation, including data compilation, tables, and figures.
- Participate in peer reviews of scientific reports and assist in data interpretation.
- Review QAU audit reports and submit responses after SD/PI approval.
- Manage client feedback and ensure report/data clarifications are completed.
- Learn to handle complex projects and study designs.
- Assist in report finalization and data archiving.
- Engage in client visits and communications under SD/PI guidance.
- Monitor financial status of ongoing studies, including scope changes.
About the Company
A leading organization in clinical research and pharmaceutical studies, this company is committed to advancing scientific research while maintaining compliance with global regulatory standards. With a strong presence in Bangalore, it offers a dynamic work environment for professionals looking to grow in clinical trial management, regulatory affairs, and study coordination.
