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Clinical Trial Coordinator

Clinical Trial Coordinator

ClinoGenesis Research InstituteBangalore (division)
24 days ago
Job description

📌 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 (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
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    Clinical Clinical • Bangalore (division)

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