Clinical Research Executive

Asian Heart Institute; Mumbai; On-site; INR 600,000 - 900,000; Full time

Job summary

Asian Heart Institute is seeking a Clinical Trials Coordinator to oversee trial conduct in line with ICH-GCP guidelines. You will work closely with investigators, sponsors, IRBs, and regulatory bodies to ensure high-quality research.

The role involves maintaining trial documentation, training staff, safeguarding participant rights, and timely reporting of adverse events and deviations, while identifying new research opportunities for collaboration.

Qualifications

• Bachelor’s or Master’s in Life Sciences with a Certificate in Clinical Research or a related clinical research degree.
• Excellent written and oral communication skills.
• Preference for ICH-GCP trained professionals.

Responsibilities

• Coordinate with Principal Investigators (PIs), IRBs, Sponsors/CROs and research teams to execute clinical trials.
• Recruit and follow up with trial participants to ensure their well-being.
• Maintain trial databases, logs and documentation for regulatory compliance.
• Ensure adherence to Good Clinical Practice (GCP) guidelines and 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 and Case Report Forms (CRFs).
• Archive trial documents for retention as required.
• Identify potential research opportunities and liaise with sponsors.

Skills

Communication skills

ICH-GCP trained

Education

Bachelors/Masters in Life Sciences with Certificate in Clinical Research

Bachelors/Masters in Clinical Research

Job description

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/MastersinClinical Research
• Excellent written and oral communication skills.
• Preference for ICH-GCP trained professional.

About Asian Heart Institute

Asian Heart Institute is India's #1 cardiac hospital dedicated to incorporating the latest technological advances and ethical practices to provide quality heart care at reasonable costs. As a JCI, NABH, and ISO-accredited hospital with a staggering success rate of 99.83% in bypass surgeries and an overall 99.4% in cardiac surgeries, we are considered among the best globally.

Our foundation rests firmly on four core pillars: Ethics, Experience, Excellence, and Expertise. At the heart of our approach is a steadfast commitment to integrity and ethical practices, ensuring that every patient is treated with the highest level of respect and care. We take pride in our team of renowned experts, each contributing years of specialized experience and skill, which is pivotal in driving our pursuit of excellence. Our focus on expertise is not just about having the best professionals on board, but and fostering continuous learning and staying ahead in our field.