Sponsor Contract Clinical Research Associates


Category: CRA
Job #: 10788
Utilization: 40%↑
Location: Texas
Job Type: 1099
Therapeutics: Ophthalmology

One of our Sponsors is looking for contract CRAs in Texas with at least 40% utilization available to work on a Phase I Ophthalmology study. Qualified candidates will have a minimum 5 years' recent experience as a fully dedicated Regional, Home-Based, Field Monitor for a CRO or Pharma.

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:
  • Must have a minimum 5 years' recent experience as a fully dedicated Regional, Home-Based, Field Monitor for a CRO or Pharma
  • At least 2 years' experience monitoring Ophthalmology is required (with Retina experience a plus)
  • Experience monitoring Phase I studies is required
  • Experience working with cell-based gene therapy (with specific interest in CAR T-cell therapy) is a plus
  • At least 40% Utilization required

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