Sponsor Clinical Research Associates – Rare/Orphan Disease

Category: CRA
Job #: 10812
Utilization: 50%↑
Location: Anywhere US
Job Type: 1099 or Perm
Therapeutics: Rare/Orphan Disease

We have Sponsor clients who are launching Rare/Orphan Disease studies and are seeking Contract or Perm CRAs with at least 50% utilization. Must have a minimum of 3 years’ 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 of 3 years’ experience as a fully dedicated regional, home based, field monitor for a CRO or pharma.
  • Must have at least one year of experience monitoring Rare/Orphan Disease
  • Must have at least 50% utilization available
  • A Nursing or Medical background is a plus
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