Sponsor BE/HV Contract CRA in South Florida

Category: CRA
Job #: 10911
Utilization: 10%↑
Location: Miramar FL
Job Type: 1099
Therapeutics: Bioequivalence Experience

One of our sponsors is seeking experienced contract CRAs in Southern Florida to monitor Phase I Bioequivalence studies. These are partial contracts requiring 2-4 days of dedication per project. The need will be ongoing; therefore, continued engagement can be expected.

The sponsor will coordinate with your schedule; therefore, there is significant flexibility and a perfect project to dovetail into another assignment!

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:
  • Senior CRAs only - must have at least 5 years' experience as a fully dedicated, home-based, Clinical Research Associate/Site Manager/Field Monitor.
    • This experience must have been gained by working directly for a CRO or Pharma.
    • Only recent monitoring experience will be accepted (i.e., must have monitored within the last 2 years).
  • Must have at least 10% utilization available and be able to coordinate 2-4 day onsite visits with this sponsor.
  • Experience in monitoring Phase I Bioequivalence projects, which enroll Healthy Volunteers, is a firm requirement.
  • A bachelor's degree is strongly preferred, but equivalent experience will be considered.
  • Must be COVID vaccinated.
  • Only candidates within commuting distance of Miramar, FL, will be considered (CRAs within Florida with a direct flight to Miami will also be considered).
Apply for this job:

  • This field is for validation purposes and should be left unchanged.
  • Max. file size: 32 MB.