Job Description
Job Description
Job Description
The Clinical Operations Associate will support the day-to-day management of outsourced clinical trials, ensuring studies are conducted in compliance with protocols, ICH-GCP, regulatory requirements, and SOPs.
Key Responsibilities:
- Assist with study start-up, including preparation and review of study documents, site contracts, and vendor budgets.
- Track subject recruitment, monitoring visits, protocol deviations, and site performance.
- Maintain essential documents and the Trial Master File (TMF).
- Coordinate with CROs, vendors, and investigator sites to support study execution.
- Participate in audits, inspections, and risk assessments.
- Prepare agendas, minutes, and status reports for project updates.
Qualifications:
- Experience supporting clinical trial operations.
- Working knowledge of clinical protocols and ICH-GCP guidelines.
- Strong organizational, time management, and communication skills.
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