Clinical Research Associate
17 hours ago
The Clinical Research Monitor / CRA / Site Monitor will coordinate clinical studies and shall be responsible for study execution, monitoring, site-training and close-out.
- Coordinating site selection, contract negotiation, IRB/EC submissions, study initiation, monitoring, and site close-out.
- Liaising and maintaining relationships with investigators, site staff & ethics committees.
- Maintain & monitoring the TMF.
- Managing operational interface with sponsors.
- Perform (remote & on-site) monitoring of sites operations & CRO operations.
- Training project teammates & site staff on regulations, protocol procedures & general SOPs.
- Periodic review of project KPIs for ensuring and securing compliance with regulations, budgets and timelines.
- Compiling & presenting project progress to sponsors and senior Management.
- Maintaining audit readiness at sites & of CRO operations.
- Providing operational insights for compliance with Protocol, SOPs, policies and practices.
- Coordinating logistics for study supplies & biospecimen.
- Coordinate with internal stakeholders, vendors & partners to ensure smooth conduct of the study.
- 3+ years of experience in clinical research operations and project management, preferably in global clinical trials.
- A degree in medicine, pharmacy, or life sciences.
- Willingness to travel to sites across countries/cities.
- In-depth understanding of clinical research regulations, industry standards and GCP.
- Excellent verbal and written communication skills.
- Proficiency in using MS Word & MS Excel.
Schedule:
- Day shift
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