High Acuity Device Sponsor CRA (Contract – US)
This will be one of the coolest studies you will ever work! One of our Device Sponsor partners is launching a new Phase III Device study and therefore looking for several CRAs across the US.
Previous experience in Device is *NOT* a requirement, although having experience in High-Acuity settings such as monitoring in-patient surgical trials or previous experience as a high-acuity nurse is.
This project will keep you busy, therefore we are looking for CRAs who are able/willing to commit to 100% utilization.
- 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.
- BS or BA in relevant field with RN, Nursing degree or relevant medical background preferred
- Minimum 3 years’ experience as a fully dedicated Regional, Home Based, Field Monitor for a CRO, Medical Device company or Pharma; this experience should be recent (i.e. - no longer than 2 years ago.)
- At least 1 year's experience monitoring in-patient / surgical studies. Previous experience as a Critical Care or High-Acuity nurse will be considered.
- Willing to travel as required to conduct monitoring visits as needed