Clinical Trial Coordinator

Job Description – Clinical Trial Coordinator (CTC) | Hyderabad 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 1️⃣

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

2️⃣

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

3️⃣

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

4️⃣

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

5️⃣

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, Pharm D, D Pharm, BDS, MD, MBBS, BAMS, BUMS, BYNS, BPT, DMLT, Microbiology, Biochemistry, Biotechnology, (Life Sciences, Biotechnology, Nursing, or related field)

Experience

0–1 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