Clinical Research Associate III
Association of Clinical Research Professionals - San Diego, CA

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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