Sponsor Contract Clinical Research Associates

Category: CRA
Job #: 10902
Utilization: 100%
Location: Great Lakes and Northeast US
Job Type: 1099
Therapeutics: Device and Endoscopy, Cardiology, or Electrophysiology

One of our mid-to-large sized Sponsors is experiencing significant growth and has an urgent need for multiple contract CRAs near the airports in Detroit, Minneapolis, Chicago, Washington DC , Philadelphia, or New York City. They need the CRAs to have 100% utilization available, (40 hours a week) for an 18 month contract. They do need their contractors to have at least one year of experience monitoring device trials, as well as medical or CRA experience in one of these indications: Endoscopy, Cardiology, or Electrophysiology. There is also a chance to go perm after the 18 month initial contract term. Apply below if you are interested in being considered.

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 5 years’ experience as a fully dedicated regional, home based, field monitor for a CRO or pharma
  • BS or BA degree 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 the airports in Detroit, Minneapolis, Chicago, Washington DC , Philadelphia, or New York City
  • Have 100% utilization for the next 18 months
  • Competitive Hourly Rate
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