Sponsor Remote Contract Clinical Research Associates


Category: CRA
Job #: 10766
Utilization: 50%↑
Location: Anywhere US (but must support East Coast hours)
Job Type: 1099
Therapeutics: Device (monitoring) and Psychiatry, Neurology, or CNS (any role)

One of our Sponsors is looking for Remote Contract CRAs in the US with at least 50% utilization available for a Device study. Can be located anywhere in the US but must be able/willing to work East Coast (US) business hours (though the position is mostly remote, there may be some travel)

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.
  • Can be located anywhere in the US but must be able/willing to work East Coast (US) business hours (though the position is mostly remote, there may be some travel)
  • Must have at least 50% utilization
  • Minimum of 1 year of experience monitoring Device studies is required
  • Must have experience working Psychiatry, Neurology, or CNS (in any role)Must have experience writing, or assisting in writing, monitoring plans, SOPs, and other manuals while working for a CRO or Sponsor
  • Experience monitoring Alzheimer's or with studies conducting memory assessments is a plus
  • Experience monitoring or working in Diagnostic studies, as well as experience experience participating in CRF and ICF reviews is a plus

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