Job Description: 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. Knowledge/Experience Required: The successful candidate must have:
A Bachelor's or Master's degree in a relevant scientific or health-related field.
A minimum of six (6) years of clinical monitoring, with preference to those with clinical project management and CRO management experience within the biotech/pharmaceutical industry.
Experience in contributing to the design of trial documents including but not limited to clinical protocols, consent forms, case report forms, site study manuals, and project/tracking tools.
Ability to perform effectively in a team environment, collaborating effectively with other departments such as Regulatory Affairs, and Quality Assurance.
Strong working knowledge of Good Clinical Practices (GCP), U.S. Food and Drug Administration (FDA) regulations, and International Committee on Harmonisation (ICH) guidelines.
Excellent oral and written communication skills.
Proficiency in basic computer programs (e.g. MS Word, Excel, PowerPoint). Internal Number: 201402