Clinical Trial Coordinator

4 weeks ago

New Delhi, India ClinoGenesis Research Institute Full time

Job Description – Clinical Trial Coordinator (CTC) | HyderabadAbout the RoleThe 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 1️⃣Study Coordination & Site ManagementAssist in setting up and initiating clinical trials at the siteEnsure all study supplies, documents, and equipment are availableMaintain Investigator Site File (ISF) and Essential DocumentsCoordinate participant recruitment, screening, informed consent, and follow-upSupport investigators in scheduling study visits and managing study calendars2️⃣Data Management & DocumentationPerform 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/IRB3️⃣Regulatory & Compliance SupportEnsure 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 findings4️⃣Participant CoordinationManage 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 guidelines5️⃣Stakeholder CollaborationWork closely with CRAs, sponsors, investigators, and hospital departmentsSupport communication and coordination between clinical and research teamsRequired Qualifications & Skills EducationB.Pharm / M.Pharm / B.Sc / M.Sc (Life Sciences, Biotechnology, Nursing, or related field)Experience0–3 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 SkillsKnowledge of ICH-GCP guidelinesFamiliarity with eCRF/EDC systemsUnderstanding of regulatory documentationKnowledge of clinical trial phases and site workflowsSoft SkillsExcellent communication & interpersonal skillsStrong organizational and multitasking abilityAttention to detail and documentation accuracyAbility to work in a hospital/clinical research environmentWhat the Role OffersHands-on experience in clinical trial operationsExposure to regulatory and ethical processesCollaboration with experienced investigators and CRAsCareer growth in clinical research, site management, & pharmacovigilance

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