job title: clinical research executive(asian heart institute)

Clinical Research Executive

Mumbai, Maharashtra, India

Full Time

Position
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 professional.