Contract Clinical Research Associates for Federal Projects (U.S.)
One of our partners has an immediate need for several Long-Term Contract Clinical Research Associates with 100% utilization to work on Federal projects. Our client is looking for someone with diverse therapeutic experience. Experience with Allergy & Asthma, Transplant, or Infectious Disease 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.
- 5 years’ monitoring experience
- Must have at least 100% utilization available
- Diverse therapeutic experience, preferred
- Travel as appropriate, required
- Strength in EDC/CTMS systems, preferred
- RN, BA, or BS degree in scientific field, preferred (equivalent experience will be considered)