📌 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 systemsReview source documents and ensure data accuracy & query resolutionMaintain study logs : screening, enrollment, adverse events, delegations, etc.Assist in preparing regulatory documents and submissions for IEC / IRB3️⃣ Regulatory & Compliance Support
Ensure trial conduct complies with ICH-GCP, SOPs, and protocol requirementsAssist with SAE reporting, protocol deviations, and adherence monitoringPrepare for site audits / monitoring visits and support response to findings4️⃣ Participant Coordination
Manage patient flow for study visits and ensure protocol-specified proceduresEducate participants about study requirements and follow-up schedulesAssist in sample collection, processing, and shipment as per guidelines5️⃣ Stakeholder Collaboration
Work closely with CRAs, sponsors, investigators, and hospital departmentsSupport 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 domainFreshers with strong interest in clinical research may also be considered (optional based on employer)Technical Skills
Knowledge of ICH-GCP guidelinesFamiliarity with eCRF / EDC systemsUnderstanding of regulatory documentationKnowledge of clinical trial phases and site workflowsSoft Skills
Excellent communication & interpersonal skillsStrong organizational and multitasking abilityAttention to detail and documentation accuracyAbility to work in a hospital / clinical research environment🔹 What the Role Offers
Hands-on experience in clinical trial operationsExposure to regulatory and ethical processesCollaboration with experienced investigators and CRAsCareer growth in clinical research, site management, & pharmacovigilance