Contract Clinical Research Associate (50%)
Job #: 10594
Location: West Coast
Job Type: 1099
A Sponsor Client is looking for multiple cCRAs with at least 50% utilization available to monitor a hema oncology study on the West Coast. This is a long term contract with a growing, dynamic pharma company.
- 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 50% utilization / availability required; additional utilization is available if desired
- Minimum 3 years' experience as a fully dedicated regional, home-based, field monitor for a CRO or pharma
- 2 years' experience monitoring Oncology studies is required
- Previous experience monitoring Hema Oncology is a plus
- Minimum Bachelor's Degree required; obtained in a life science or medical field preferred
- A nursing or medical background is a plus
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