Ophthalmology Contract CRA (Anywhere in US)
One of our partners has several long term partial contract CRA positions available to conduct a large Ophthalmology project. Qualified candidates can be located anywhere in the US and will have additional opportunities to work with this sponsor on upcoming studies.
- 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 3 years’ experience as a fully dedicated Regional, Home Based, Field Monitor for a CRO or Pharma; this experience should be recent (i.e. - no longer than 2 years ago)
- At least 1 year experience monitoring ophthalmology studies required
- Bachelor's Degree required / Nursing degree preferred
- Proficient with EDC systems
- Willing to travel as required to conduct monitoring visits