Coming Soon: Sponsor Contract Clinical Research Associates

Category: CRA
Job #: Coming Soon
Utilization: 50%
Location: East Coast/Midwest US
Job Type: 1099
Therapeutics: MS and Hema/Oncology

A Sponsor Client is looking for contract CRAs located on the East Coast or in the Midwest US to monitor a Hema/Oncology Study. This long term contract requires a minimum of 50% utilization but more is available.

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 be flexible with travel and close to a major airport
  • Hema Oncology experience is required
  • Multiple Sclerosis (MS) experience is a plus
  • 50% utilization is required but more is available

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