Sponsor Contract Clinical Research Associates
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.
- 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.
- 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