Contract Clinical Research Associate, Ulcerative Colitis
We are actively seeking multiple contract Clinical Research Associates (CRAs) for an exciting opportunity supporting a global Partner known for consistent, on-time delivery and a strong track record across major therapeutic areas. The study is a Phase II-III Ulcerative Colitis trial, and our Partner has not yet finalized a site listing, so this role is open nationwide to CRAs who are genuinely flexible with coast to coast travel. This is a fully onsite monitoring role requiring approximately 8 days on site per month, and our client is looking to fill these two spots soon. We are seeking CRAs who have a minimum 5 years of recent experience as a fully dedicated regional/home-based field monitor for a CRO or pharma, at least 1 year of Ulcerative Colitis monitoring experience (strong preference within the last 2 years), no degree requirement, located anywhere in the US with proximity to a major airport, and full availability at 100% utilization. Apply below if this is you!
- 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 5 years of recent experience as a fully dedicated regional/home-based field monitor for a CRO or pharma, within the last 2 years
- At least 1 year of Ulcerative Colitis monitoring experience, with a strong preference that it has been within the last 2 years
- Located anywhere in the US, with no travel restrictions and proximity to a major airport
- Must be available for 100% utilization / 40 hours a week
- Long-term contract
- Competitive pay rate