Junior Cardiac Device Sponsor CRA (Major Airport US)

Category: CRA
Location: US (close to major airport)
Job Type: Perm (Home-Based)
Rate / Salary Range: 75-100k Salary

One of our Sponsor Partners needs a Clinical Research Associate (CRA) to join their team to monitor a Cardiac Device study. This is a terrific opportunity to work directly for a Sponsor company!

Qualified candidates will live anywhere in the US close to a major airport. Must be flexible in travel.

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 1 years’ experience as a fully dedicated Regional, Home Based, Field Monitor for a CRO or Pharma; this experience should be recent (i.e. - no longer than 2 years ago).
  • At least 1 year experience monitoring Device studies required.
  • Cardiovascular experience (any role).
  • Hospital or In-Patient Surgical experience (any role).
  • Willing to travel as required to conduct monitoring visits.

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