Overactive Bladder Contract CRAs (Anywhere US)

Category: CRA
Location: Anywhere US
Job Type: 1099 / Regional Homebased
Rate / Salary Range: Per Unit / Per Visit

One of our Partners is launching a huge Overactive Bladder study and therefore is looking for several high quality CRAs to join their team. This is a long term project, expecting to last through 2020.

Contract CRAs who desire both full and partial utilization will be 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:
  • Minimum 4 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)
  • RN, BA or BS Degree in Scientific Field Preferred (equivalent experience will be considered)
  • Experience Monitoring OAB studies a plus (relevant experience will be considered)
  • Must have GCP certification or be willing to obtain it
  • Proficient with EDC systems
  • Submission of writing samples (redacted study report, follow-up letter, confirmation letter) required
  • Willing to travel as required to conduct monitoring visits / be on site 3-4 days a week if fully utilized

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