Device Sponsor Contract Clinical Research Associates

Category: CRA
Job #: 10917
Utilization: 100%
Location: Detroit, Minneapolis, Chicago, Washington DC, Philadelphia, New York City, Boston, Memphis or Los Angeles
Job Type: 1099
Therapeutics: Device and Endoscopy, Cardiology, or Electrophysiology

One of our leading Sponsors is experiencing impressive growth and they have an immediate need for several contract CRAs to support their Device studies in Endoscopy, Cardiology, and Electrophysiology.​

This contract guarantees you 40 hours per week on a minimum 18-month contract, with good potential to extend longer. This is a wonderfully supportive team in a stable environment, working on some of the most innovative therapeutic areas out there.​

If you want to become part of this team then apply today!

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:
  • A minimum of 2+ years’ experience as a fully dedicated regional, home based, field monitor for a CRO or pharma (Hourly rate commensurate with experience)
  • BS or BA degree, or RN is a requirement
  • Must have at least 1 year experience monitoring Device trials
  • Must have medical or CRA experience in one of these indications: Endoscopy, Interventional Cardiology, or Electrophysiology. It is a plus if you also have experience working on Neuromodulation trials
  • Experience with VeevaVault (CTMS) or MediData RAVE (EDC) is a plus
  • Must be located within an hour drive of a major airport in Detroit, Minneapolis, Chicago, Washington DC , Philadelphia, New York City, Boston, Memphis or Los Angeles
  • Have 100% utilization for the next 18 months
  • Competitive Hourly Rate
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