This role involves coordinating clinical trials, ensuring compliance with ICH-GCP guidelines, and working closely with investigators, sponsors, and regulatory bodies to conduct high-quality research.
Key Responsibilities
- Coordinate with Principal Investigators (PIs), Institutional Review Boards (IRB), Sponsors/CROs, and research teams to execute clinical trials.
- Recruit and follow up with trial participants to ensure their well-being throughout the study.
- Maintain trial databases, logs, and documentation for regulatory compliance.
- Ensure adherence to Good Clinical Practice (GCP) guidelines and applicable regulatory requirements.
- Train staff on trial-related duties and ethical considerations in clinical research.
- Protect the rights and confidentiality of all trial participants.
- Ensure timely and accurate reporting of trial data, including adverse events and protocol deviations.
- Manage documentation, including informed consent forms, Case Report Forms (CRFs), and other regulatory submissions.
- Archive trial-related documents for the required retention period.
- Identify potential research opportunities and liaise with sponsors.
Requirements
- Bachelors/Masters in Life Sciences w/ Certificate course in Clinical Research, OR
- Bachelors/Masters in Clinical Research
- Excellent written and oral communication skills.
- Preference for ICH-GCP trained qualified.
📌 Clinical Research Executive (Mumbai)
🏢 Asian Heart Institute
📍 Mumbai
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