Our client, a well-established pharmaceutical company is looking for a motivated and experienced Clinical Research Associate III to join their team.
The candidate will be responsible for assisting in monitoring the operational implementation of Phase 1-3 infectious disease vaccine trials for a small biotechnology company in San Diego, reporting to the VP.
Clinical Vaccines. Responsibilities include:
• Achieving U.S. Food and Drug Administration (FDA) standards for subject safety and data integrity.
• Assist in the managing a Contract Research Organization (CRO) in the conduct of clinical trial(s).
• Fostering effective and collaborative interactions among Clinical and Company employees and with the staff of multiple U.S. trial sites.
• Striving to meet, if not exceed, company timelines.
• Participating in project teams to ensure smooth trial enrollment and expeditious troubleshooting when operational issues arise.
• Working very closely with a small clinical team, apprising senior clinical management on trial status on a daily basis.
• Providing training and oversight to comply with Good Clinical Practice (GCP) guidelines.
In addition to the responsibilities described above, the candidate will:
• Remain current in the latest standards of clinical trial conduct.
• Track issues of clinical operations importance.
• Assist in overseeing multiple contracts and contractors, including a contract research organization (CRO).
• Demonstrate strong organizational and problem-solving abilities in addressing and rectifying operational issues.
• Display firm approach in interacting with CRO, vendors and contractors.