Clinical Research Associate (Maryland / Pennsylvania)
One of our Sponsor Partners is looking for a contract CRA with a medical background and 3-5 years experience as a Sr CRA. This monitor should have at least 1-year Ophthalmology experience, and at least 25% utilization to monitor an Ophthalmology study. This device study will be for the treatment of patients with dry AMD. Qualified candidates will need to be located in the MD/PA area and willing to travel when sites open.
- 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 at least 1 year's experience monitoring Ophthalmology studies
- Must have at least 25% availability
- Must be willing to travel when sites are opened (currently remote monitoring due to Covid-19
- Must be located in the MD/PA area
- A medical background is a huge plus
- Dry AMD experience is a plus
- A bachelor's degree is strongly preferred