Sponsor Clinical Research Associate

Category: CRA
Job #: 10877
Utilization: 10-30%
Location: Anywhere US
Job Type: 1099
Therapeutics: Medical Device and Metabolic/Endocrinology

We have a unique opportunity for a CRA in the US with 10-30% utilization to monitor a mock trial for a Device company that's getting ready to launch several regular trials. Must have experience with Medical Device and Metabolic/Endocrinology studies. Must have a minimum 5 years experience as a fully dedicated regional, home-based, field monitor for a CRO or Sponsor.

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 experience as a fully dedicated regional, home-based, field monitor for a CRO or Sponsor
  • Must be located in the US close to a major airport
  • Must have 10-30% utilization available
  • Experience with Medical Device and Metabolic/Endocrinology studies is required
  • Experience with Study Start-up and Study Design is a plus
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