Sponsor Contract Clinical Research Associates
One of our Sponsor Clients is in need of contract CRAs for monitoring a Cardiac Device study at 50% utilization. This is a long term contract with a growing, dynamic company. Must have a minimum of 3 years’ 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 of 3 years’ experience as a fully dedicated regional, home based, field monitor for a CRO or pharma.
- Must have at least one year of experience monitoring Cardiology and Device
- Must have at least 50% utilization available
- A Nursing or Medical background is a plus