About the Role
We are seeking a detail-oriented and motivated Clinical Research Coordinator (CRC) to manage and coordinate clinical research studies in accordance with study protocols, regulatory guidelines, and Good Clinical Practice (GCP). The ideal candidate will ensure smooth execution of clinical trials while maintaining participant safety, data quality, and regulatory compliance.
Key Responsibilities
- Coordinate and manage clinical research studies from initiation to completion.
- Screen, recruit, and enroll eligible study participants.
- Obtain informed consent in compliance with ethical and regulatory requirements.
- Schedule participant visits and coordinate study-related procedures.
- Collect, review, and maintain accurate clinical research data and source documentation.
- Ensure compliance with study protocols, GCP, ICH guidelines, and applicable regulatory requirements.
- Prepare and maintain regulatory documents, investigator site files, and essential study records.
- Coordinate with Principal Investigators (PI), sponsors, Contract Research Organizations (CROs), and ethics committees.
- Report adverse events (AEs), serious adverse events (SAEs), and protocol deviations promptly.
- Assist in monitoring visits, site audits, and regulatory inspections.
- Maintain inventory and accountability of investigational products and study supplies.
- Ensure timely data entry into Electronic Data Capture (EDC) systems and resolve data queries.
- Prepare periodic study progress reports and maintain confidentiality of participant information.
Required Qualifications
- Bachelor's or Master's degree in Pharmacy (B.Pharm/M.Pharm), Life Sciences, Nursing, Biotechnology, Biochemistry, Microbiology, or a related field.
- 1–3 years of experience in clinical research or clinical trial coordination (Freshers with relevant internship experience may also apply).
- Knowledge of ICH-GCP guidelines, clinical trial regulations, and ethical standards.
- Familiarity with EDC systems and Microsoft Office applications.
- Strong organizational, communication, and documentation skills.
Preferred Skills
- Clinical trial coordination experience.
- Regulatory documentation and site management.
- Participant recruitment and retention.
- Medical terminology and clinical documentation.
- Problem-solving and multitasking abilities.
- Ability to work independently and collaboratively with multidisciplinary teams.
Pay: ₹15,000.00 - ₹40,000.00 per month
Benefits:
Work Location: Hybrid remote in Bhawanipur, Kolkata, West Bengal
