Sponsor Clinical Research Associate – Vaccine Study

Category: CRA
Job #: 10920
Utilization: 25%
Location: Remote but Commute Distance to Baltimore MD
Job Type: 1099
Therapeutics: Vaccine

Join a small, collaborative vaccine research team pushing the boundaries of leading-edge innovation in the vaccine space. This short-term contract role requires 25% utilization, offering flexibility for experienced CRAs seeking impactful work without full commitment.

The awarded CRA gains entry to future projects within this dynamic team, building long-term opportunities in high-demand vaccine research. Perfect for flexible, accountable professionals with strong communication skills and vaccine or relevant therapeutic experience.

Job Responsibilities:
  • Act as the "Site Manager," ensuring relationships with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
  • Assist with the development of study manuals, CRFs, monitoring standards, site study tools, and other study materials as required.
  • Develop and implement site recruitment, selection, and initiation plan.
  • Manage and drive patient recruitment and enrollment tracking.
  • Provide training to sites on the study protocol, study conduct, CRF completion, and data management expectations.
  • Ensure essential document collection for completeness per regulatory requirements.
  • Serve as a liaison with Investigators, Institutions, and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedures.
  • Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs.
  • Manage one or multiple studies.
  • Monitor product supplies/accountability, including proper storage, dispensation, and disposal.
  • Manage study completion activities, including CRF collection, query resolution, record archiving, and site closeout activities.
  • Review in-house data and study tables.
  • Mentor, coach, and provide guidance to clinical staff as appropriate.
  • Supervise and train other employees as appropriate.
Job Qualifications:

Must have:

  • A minimum of 5 years’ experience as a fully dedicated regional, home-based, field monitor, having gained that experience working directly for a CRO or pharma.
  • At least two years of experience monitoring Vaccine studies (1 year of experience may be considered based on overall experience).
  • At least 25% utilization available.
  • Previous experience monitoring projects using the Risk-Based Monitoring Methodology.
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