About the role
Key Responsibilities1. Study Coordination
- Assist in planning, initiation, and coordination of clinical trials under the supervision of the Principal Investigator.
- Ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.
- Perform and manage CTRI registrations accurately and within timelines.
- Prepare, review, and submit Ethics Committee (EC) submissions on a weekly basis.
- Maintain all regulatory documentation and ensure timely updates and approvals.
- Identify and screen eligible study participants.
- Maintain accurate screening and enrollment logs.
- Facilitate and document the informed consent process in compliance with regulatory standards.
- Accurately collect, record, and maintain study data.
- Perform routine data quality checks and validations.
- Coordinate with investigative sites and internal teams for smooth study execution.
- Assist in regulatory document preparation and submissions.
- Monitor, document, and report adverse events as per regulatory guidelines.
- Support participant safety oversight in collaboration with the study team.
- Participate in ongoing training programs.
- Stay updated with clinical research regulations and industry trends.
- Bachelor’s degree in Life Sciences or a related field.
- 0–3 years of experience in BA/BE studies (mandatory).
- Strong organizational and multitasking abilities.
- Excellent communication and interpersonal skills.
- High attention to detail and accuracy.
- Good understanding of GCP and regulatory requirements.