Clinical Research Associate (Southeast)
One of our Small Sponsors is looking for an experienced CRA to monitor a Pulmonary Arterial Hypertension study. The main site is in Jacksonville, FL, and this CRA will need to be within driving distance of Jacksonville and willing to fly to other sites when they re-open. Qualified candidates will have a minimum 3 years' recent experience as a fully dedicated Regional, Home-Based, Field Monitor for a CRO or Pharma.
- 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.
- Utilization estimated to be 50-75%
- Previous experience monitoring early phase studies is required
- At least 2 years' experience monitoring Respiratory / Pulmonary studies is required
- Experience performing site management is required
- Hourly rate (1099) between 75-85 (covered door to door)