Contract Clinical Research Associates

Category: CRA
Job #: 10850
Utilization: 25%-50%
Location: Mid-Atlantic or Northeast US (Washington DC area is a plus)
Job Type: 1099
Therapeutics: Rare Disease

We have a great partner with a need of contract CRAs in the to monitor a rare disease study at a site in the Washington DC area (commuting distance preferred). At least 25-50% utilization required at first, but could ramp up in the next couple of months. Must have a minimum 5 years' recent experience as a fully dedicated Regional, Home-Based, Field Monitor for a CRO or Pharma.

Job Responsibilities:
  • Act as the "Site Manager" ensuring relationship 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 5 years' recent experience as a fully dedicated Regional, Home-Based, Field Monitor for a CRO or Pharma.
  • Must be located in the Mid-Atlantic or Northeast US (commute distance to Washington DC area is a plus)
  • At least 1 year of experience monitoring Rare Disease is required
  • Experience monitoring Hematology, Hepatology, or OTC (Ornithine Transcarbamylase Deficiency) is a plus
  • At least 25-50% utilization required at first, but could ramp up in the next couple of months
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