Contract Clinical Research Associate, Cardiac Device preferred

Category: CRA
Job #: 10940
Utilization: 50%↑
Location: In US, in Northeast, Southeast, Midwest, or Southwest regions, or in Colorado or Utah
Job Type: 1099
Therapeutics: No Specific TA Required

One of our favorite long-term clients, a mid-sized Sponsor known for their positive, collaborative culture, is looking to add a contract Clinical Research Associate to their team to cover sites throughout the US.

This is a great opportunity for a CRA with Risk-Based Monitoring experience, which is required. Device trial monitoring experience, cardiovascular study experience (in any clinical research capacity), and familiarity with inpatient or surgical study settings are all a plus, though not required.

If this sounds like your background and you're ready for your next contract with a company that genuinely values its people, apply now!

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:
  • Minimum 5 years' recent experience as a CRA while working for a CRO or Sponsor
  • Must be located in the US, in the Northeast, Southeast, Midwest, or Southwest regions, or in Colorado or Utah, with no travel restrictions and close proximity to a major airport
  • At least 50% utilization required
  • Must have experience in Risk-Based Monitoring
  • Bachelor's degree in a science or technical related field required
  • It is preferred that you have experience monitoring Device studies
  • It is preferred that you have experience working within Surgical/In-Patient studies, either as a CRA or at the site level
  • It is preferred that you have experience within the Cardiovascular therapeutic, either as a CRA or at the site level
  • It is preferred that you speak/write in French
  • If interested, may offer CRA a conversion to Perm
  • Competitive Pay Rate
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