Contract Clinical Research Associate – Urology
We’re partnering with a wonderful client to identify multiple experienced Contract Clinical Research Associates (cCRAs) for a Urology-based clinical trial spanning 10 sites across the U.S. Ideal candidates will have at least 5 years of recent, independent CRA experience, while working directly for a CRO or Sponsor, 2+ years' experience monitoring Urology studies, and 1 year experience monitoring Endocrinology studies. Experience with PK sampling oversight, TMF maintenance, and sponsor-attended visits is highly valued. Based on site locations, the client would like to see CRAs in the West, Southwest, or East Coast regions in the U.S.
Flexibility is key - this role requires coast-to-coast travel and may involve supporting additional clinical and operational tasks beyond traditional CRA responsibilities. Candidates with prior experience in hypogonadism or endocrinology studies are especially encouraged to apply.
- Act as the "Site Manager," ensuring relationships 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.
- At least 5 years of experience working as a CRA for a CRO or Sponsor within the past 2 years
- Must be located in the West, Southwest, or East Coast US Region
- At least 2 years of experience monitoring Urology studies
- At least 1 year of experience monitoring Endocrinology studies
- Any experience with monitoring pK sampling
- Must have a Bachelor’s degree, preferably in a life science or related field of study
- Able to travel, as needed
- Able to contribute with additional support that might not be strictly CRA-type activities (CTA support), etc.
- Clear understanding of TMF Maintenance and able to support TMF activities
- Previous experience with sponsor joining monitoring visits
- It is a plus if you have experience in any role working on hypogonadism clinical research studies