Women’s Health Sponsor Oversight CRAs (East and MW US Regions)
One of our favorite Sponsors is looking for an Oversight CRA to join their team. This Oversight CRA will be responsible for the assessment of the CRO's CRAs who are monitoring the study.
This Oversight CRA will need to be able and willing to be on site 4 days a week. This is a 100% utilization contract and expected to be long term.
- 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.
- Minimum 3 years’ experience as a fully dedicated Regional, Home Based, Field Monitor for a CRO or Pharma; this experience should be recent (i.e. - no longer than 2 years ago.)
- Experience assessing other CRAs required
- Experience in Women's Health is a Plus
- Experience with Diaries is a Plus
- Experience working with small/med sponsors is a Plus
- Proficient with EDC systems
- Willing to travel as required to conduct Oversight / Assessment visits as needed