About The Position
The Clinical Research Associate II is the primary site contact throughout all phases of clinical research studies. The role ensures compliance with regulations and supports successful clinical trials by building and maintaining strong relationships with study sites, facilitating communication, and ensuring research protocols are executed effectively. The position also contributes to continuous improvement of clinical research processes.
Requirements
- Bachelor's degree.
- Experience independently conducting on-site monitoring visits at hospitals and research centers.
- Experience managing sites throughout the clinical trial lifecycle.
- Experience preparing monitoring visit reports and maintaining clinical trial documentation.
- Strong knowledge of ICH-GCP, clinical trial processes, and regulatory requirements.
- Advanced English proficiency, written and spoken.
- Strong communication, organization, and stakeholder management skills.
Nice To Haves
- Experience in CROs and/or pharmaceutical companies.
- Experience supporting audits and inspections.
- Experience across multiple therapeutic areas and clinical trial phases.
Responsibilities
- Independently manage clinical trial sites from initiation through close-out.
- Conduct on-site monitoring visits, including SQV, SIV, routine monitoring, and close-out visits.
- Ensure compliance with protocols, ICH-GCP, sponsor requirements, and local regulations.
- Review source documents and study data to ensure quality and patient safety.
- Identify, escalate, and resolve site-related issues and risks.
- Prepare monitoring visit reports and maintain accurate study documentation.
- Maintain inspection-ready records in CTMS, eTMF, and other clinical systems.
- Build effective relationships with investigators and site personnel.
- Partner with cross-functional teams to support study delivery and site performance.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
