Contract Clinical Research Associates (30-50%)

Category: CRA
Job #: 10730
Location: Anywhere US
Job Type: 1099
Therapeutics: Device

One of our Sponsors is looking for a contract CRAs in the US with 30%-50% utilization available to work on a Medical Device / Neuromodulation study. Can be located anywhere in the US.

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:
  • Can be located anywhere in the US
  • 30%-50% Utilization required
  • Experience monitoring Device studies is required
  • Experience working directly with small/mid-sized sponsors is required
  • Experience in Neuromodulation or working with Urology clinical research projects is a plus

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