We are seeking a dynamic and experienced Clinical Research Associate to join our team. The ideal candidate will manage clinical investigational sites, ensuring accurate and timely data collection and compliance with regulatory standards.
Roles & Responsibilities:
- Study Start-Up:
- Facilitate study start-up activities at clinical investigational sites.
- Conduct feasibility assessments and site qualification visits.
- Collect essential documents for regulatory and EC submissions.
- Identify training needs and ensure supply of clinical trial material to sites.
- Site Management:
- Initiate studies at clinical investigational sites.
- Provide study protocol and related training.
- Review informed consent forms, source records, and perform SDV.
- Oversee CRF data entry and resolution of data queries.
- Ensure timely completion of site visit reports and IP accountability.
- Site Contracts and Payments:
- Coordinate clinical trial agreements and amendments.
- Review and approve site invoices and manage payment processes.
- Perform reconciliation of payments against site activities.
- Compliance and Documentation:
- Ensure compliance with protocol, SOPs, GCP, and regulatory requirements.
- Identify significant deviations and propose mitigation plans.
- Support audits, inspections, and QC visits.
- Maintain trial master file for inspection readiness
