Clinical Research Associate (Cleveland, OH)
One of our Sponsor Clients is looking for someone to monitor a Device Study. This is a great contract and might offer an opportunity to grow with this mid sized Sponsor. Because of COVID related travel restrictions, qualified candidates must be willing to drive to the office in Cleveland, OH.
- 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.
- At least one years' experience monitoring Device Studies is preferred
- 2+ years' experience monitoring studies for a small to mid sized CRO or Sponsor
- At least 25% available utilization
- A Bachelor' Degree in a Life Science or Medical discipline is required