Clinical Trial Coordinator

About the Role

The Clinical Trial Coordinator (CTC) plays a key role in supporting the planning, initiation, execution, and close-out of clinical trials. This role involves coordinating between investigators, clinical research staff, sponsors, and ethics committees to ensure smooth trial operations and compliance with regulatory and ethical guidelines.

Key Responsibilities

Study Coordination & Site Management

• Assist in setting up and initiating clinical trials at the site

• Ensure all study supplies, documents, and equipment are available

• Maintain Investigator Site File (ISF) and Essential Documents

• Coordinate participant recruitment, screening, informed consent, and follow-up

• Support investigators in scheduling study visits and managing study calendars

Data Management & Documentation

• Perform accurate and timely data entry in EDC/eCRF systems

• Review source documents and ensure data accuracy & query resolution

• Maintain study logs: screening, enrollment, adverse events, delegations, etc.

• Assist in preparing regulatory documents and submissions for IEC/IRB

Regulatory & Compliance Support

• Ensure trial conduct complies with ICH-GCP, SOPs, and protocol requirements

• Assist with SAE reporting, protocol deviations, and adherence monitoring

• Prepare for site audits/monitoring visits and support response to findings

Participant Coordination

• Manage patient flow for study visits and ensure protocol-specified procedures

• Educate participants about study requirements and follow-up schedules

• Assist in sample collection, processing, and shipment as per guidelines

Stakeholder Collaboration

• Work closely with CRAs, sponsors, investigators, and hospital departments

• Support communication and coordination between clinical and research teams

Required Qualifications & Skills

Education

B.Pharm / M.Pharm / B.Sc / M.Sc (Life Sciences, Biotechnology, Nursing, or related field)

Experience

• 0–3 years of experience in clinical research, site coordination, or related domain

• Freshers with strong interest in clinical research may also be considered (optional based on employer)

Technical Skills

• Knowledge of ICH-GCP guidelines

• Familiarity with eCRF/EDC systems

• Understanding of regulatory documentation

• Knowledge of clinical trial phases and site workflows

Soft Skills

• Excellent communication & interpersonal skills

• Strong organizational and multitasking ability

• Attention to detail and documentation accuracy

• Ability to work in a hospital/clinical research environment

What the Role Offers

• Hands-on experience in clinical trial operations

• Exposure to regulatory and ethical processes

• Collaboration with experienced investigators and CRAs

• Career growth in clinical research, site management, & pharmacovigilance