Clinical Trials Management Associate
Salary undisclosed
Checking job availability...
Original
Simplified
Overview:
- Provides support in clinical study site coordination, monitoring, and data management, either directly or through CROs.
- Contributes to study implementation, site selection, and ensures compliance with regulatory guidelines, protocols, and SOPs.
- Requires travel and strong interpersonal, written, and presentation skills.
Key Responsibilities:
- Assist with site selection, study initiation, and ongoing site coordination.
- Monitor study sites, verifying data and regulatory documents for compliance with protocol and Monitoring Plan.
- Support protocol reviews, case report forms, informed consent forms, and clinical reports under supervision.
- Compile investigator brochures and assist in resolving routine monitoring issues.
- Prepare safety, interim, and final study reports, resolving any data discrepancies.
- Participate in departmental or cross-departmental strategic initiatives and SOP development.
Education and Skills Requirements:
- Proficiency in Microsoft Word, PowerPoint, and Excel.
- Familiarity with medical/scientific terminology.
- Knowledge of FDA/EMEA regulations, ICH guidelines, and GCPs governing clinical trials (preferred).
- Excellent verbal, written, and presentation skills.
- Must meet all qualifications for the Clinical Project Assistant role.