Sponsor Contract Clinical Research Associates

Category: CRA
Job #: 10881
Utilization: 50%↑
Location: Midwest US
Job Type: 1099
Therapeutics: Solid Tumor Oncology and Phase I (any TA)

One of our long-time Sponsors is in need of contract CRAs in the Midwest US with at least 50% utilization for Phase I Oncology studies. Must have a minimum 5 years' recent experience as a fully dedicated Regional, Home-Based, Field Monitor for a CRO or Pharma with Phase 1 and Solid Tumor Oncology monitoring 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:
  • Must have a minimum 5 years' recent experience as a fully dedicated Regional, Home-Based, Field Monitor for a CRO or Pharma
  • Must be located in the Midwest US
  • Must have at least 50% utilization available
  • At least 2 years' experience monitoring Solid Tumor Oncology is required (experience with Hema-Oncology is a plus)
  • Phase 1 monitoring experience is required (Phase I Oncology is a plus)
  • Must have strong site management skills
  • Must be vaccinated for COVID-19
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