Sponsor Contract Clinical Research Associates West US
We have an exciting Sponsor in need of experienced Clinical Research Associates to support an ongoing Phase III pain management study to cover sites in Colorado, Oregon, San Diego, and Sacramento. This is a remote, home-based role with typical CRA travel. Ideal candidates will have a minimum of 5 years of experience as a fully dedicated regional field monitor for a CRO or pharmaceutical company (with this experience being no more than two years old), at least 2 years of prior experience as a Clinical Research Coordinator, and at least 1 year of experience monitoring Phase III studies in any therapeutic area. Strong organizational, communication, and medical terminology familiarity skills are essential, along with a demonstrated ability to ensure data integrity, protocol compliance, and effective site management.
- 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.
- A minimum of 5 years’ experience as a fully dedicated regional, home-based, field monitor for a CRO or pharma, with this experience being no longer than 2 years ago
- At least 2 years' experience as a Clinical Research Coordinator
- At least one year of experience monitoring Phase III studies, in any therapeutic area
- Bachelor’s degree in a Life Sciences is a requirement
- Medical Terminology familiarity required
- Working directly for a small to medium sized sponsor as a CRA is required
- Must be located in the West US
- Must have at least 50% utilization available (if you have more, there is additional work)
- Typical CRA Travel
- It is a plus if you have experience in Mediro EDC and/or Florence
- It is a plus if you have experience monitoring Pain Management studies
- Bigger plus if you have experience monitoring Osteoarthritic Knee Pain (OA) studies