Contract Clinical Research Associate (~50%)


Category: CRA
Job #: 10706
Location: US East of the Mississippi
Job Type: 1099
Therapeutics: Metabolic / Endocrinology

One of our partner organizations is seeking 1 or 2 Contract CRAs anywhere US East of the Mississippi to monitor Metabolic / Endocrinology studies at about 50% utilization.

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 3 years' recent experience as a fully dedicated Regional, Home-Based, Field Monitor for a CRO or Pharma
  • Must be located in the US East of the Mississippi
  • Must have at least one year of experience monitoring Metabolic / Endocrinology studies
  • Experience monitoring Rare / Orphan Disease or Genetic Diseases a plus
  • About 50% Utilization required

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