Clinical Research Associate I
Job Description:
- Monitor and perform quality checks on all study activities from check-in to checkout.
- Coordinate with the Project Management Group (PMG) to ensure compliance with sponsor requirements and timelines.
- Provide periodic reviews on the status of study files up to their archival.
- Coordinate with the Report Writing Group for the movement and timely management of files.
- Compile study data and review clinical reports.
- Submit protocols and other study-related documents to the Ethics Committee.
- Perform QC of Informed Consent Forms (ICF), compensation charts, and other documents prior to Ethics Committee submission.
- Ensure compliance with EC-approved protocols, GCP, SOPs, and regulatory requirements.
- Handle monitor visits, maintain site visit logs, and resolve queries raised by monitors/sponsors.
- Participate in internal and external audits.
- Review SDTM and clinical tables data with the source documents.
- Verify calibration and verification of instruments/equipment.
- Prepare and review SOPs.
- Review study documents to ensure adherence to SOPs, protocols, and regulatory requirements.
- Coordinate with the user department and medical writing department for clinical study reports.
Candidate Profile:
- Qualifications: B.Pharm, M.Pharm, M.Sc.
- Experience: 2-4 years in QC, Clinical Research Coordinator (CRC), or Nursing department in Clinical Research.
Additional Information:
- Location: Bangalore, India.
- Industry: Pharma/Healthcare/Clinical Research.
- Job ID: 55425.
- Application End Date: 30th July 2024.
Application Process:
To apply, ensure you have an updated resume that highlights your relevant experience and qualifications. You can usually apply through the company’s career page or through job portals that list this opening.
