Clinical Research Associate (Northeast US)


Category: CRA
Job #: 10583
Location: Northeast US
Job Type: 1099
Rate / Salary Range: Competitive Fixed Unit Rates

One of our Partners who specializes in rare disease is looking for a CRA to monitor sites in the Northeast US.  This is a 50% contract with Competitive Fixed Unit Rates and doesn't require any specific therapeutic experience.

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:
  • 4+ years experience as a fully dedicated, regional, home based, field monitor for a CRO or Pharma
  • 50% available utilization
  • Rare and/or Orphan disease monitoring experience is a plus

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