Sponsor Contract Clinical Research Associate II
One of our Sponsors has a need for multiple contract CRA IIs at 100% utilization who are located in MN, ND, or SD. Qualified candidates will have between 3-5 years of recent experience working as a CRA for a Sponsor or CRO.The CRA II will either need experience monitoring medical device studies or monitoring experience in on of the following therapeutics: Cardiology, Oncology, Neuromodulation, Urology, Rhythm management, Peripheral Interventions or Endoscopy.
- 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.
- Must have a minimum of 3 years' recent experience as a fully dedicated regional, home based, field monitor for a CRO or pharma
- Must be located in MN, ND, or SD
- 100% Utilization required
- Experience monitoring Device studies or experience monitoring one (or more) of the following therapeutics: Cardiology, Oncology, Neuromodulation, Urology, Rhythm management, Peripheral Interventions or Endoscopy
- While there isn't much travel, the CRA must be flexible on travel as it continues to open up
- BS / BA in the US or an RN is a firm requirement