Website:
clinogenesis.com
Job details:
Clinical Research Coordinator (CRC)
Job Title: Clinical Research Coordinator (CRC)
Employment Type: Full-Time
Experience: 0–3 Years (Freshers with relevant internships/training may apply)
Work Location: On-site
Job Summary
We are seeking a detail-oriented and motivated Clinical Research Coordinator (CRC) to support the successful execution of clinical trials in accordance with ICH-GCP, study protocols, and regulatory guidelines. The Clinical Research Coordinator will work closely with Principal Investigators, sponsors, and study participants to ensure smooth conduct of clinical research activities while maintaining participant safety, data quality, and regulatory compliance.
Key Responsibilities
* Coordinate and manage clinical trial activities from study initiation to close-out.
* Screen, recruit, and schedule eligible study participants.
* Obtain and document informed consent according to study protocols.
* Coordinate study visits and follow-up appointments.
* Collect, verify, and maintain accurate clinical research data and source documents.
* Ensure compliance with ICH-GCP, SOPs, protocol requirements, and regulatory guidelines.
* Maintain Investigator Site Files (ISF), Trial Master Files (TMF), and essential study documents.
* Report adverse events (AEs) and serious adverse events (SAEs) as per protocol.
* Coordinate with Principal Investigators, sponsors, CROs, monitors, and ethics committees.
* Prepare for monitoring visits, audits, and regulatory inspections.
* Maintain study records, logs, and documentation with high accuracy.
Required Qualifications
* Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Biochemistry, Microbiology, Clinical Research, or related disciplines.
* Knowledge of ICH-GCP, clinical trial processes, and regulatory requirements.
* Good documentation and organizational skills.
* Excellent communication and interpersonal skills.
* Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Preferred Skills
* Clinical Trial Coordination
* ICH-GCP Guidelines
* Good Clinical Practice (GCP)
* Informed Consent Process
* Patient Recruitment
* Clinical Documentation
* Source Data Verification (SDV)
* Adverse Event (AE) Reporting
* Serious Adverse Event (SAE) Reporting
* Regulatory Compliance
* Ethics Committee Coordination
* Data Management
* Medical Terminology
* Attention to Detail
* Time Management
* Team Collaboration
This role offers an excellent opportunity to gain hands-on experience in clinical research while contributing to the successful execution of clinical trials and ensuring the highest standards of participant safety and data integrity.
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