Contract Clinical Research Associate (25%+)
One of our Partners is seeking Contract CRAs to monitor an Osteoarthritis project. We need CRAs who have at least 25% utilization available who are flexible on travel restrictions and are located in the West, Southwest and Midwest. This position doesn't require any specific therapeutic though experience monitoring Osteoarthritis studies is a plus.
- 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.
- A minimum of 4 years' recent experience as a fully dedicated, Regional, Home-Based Field monitor for a CRO or Pharma
- No specific therapeutic experience is required although having Osteoarthritis experience is a plus
- Utilization: Commitment of at least 25%