Clinical Research Associate (Anywhere US)
Our client is looking for multiple CRAs to monitor studies throughout the United States. They are asking us to help build a team in different states across the US for a more regional approach. This is a fantastic opportunity for motivated individuals to join a growing team sensitive to new travel issues caused by COVID 19.
- 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 is required
- Bachelor's of Science is required
- Experience monitoring Oncology studies is required
- Required at least 50% utilization
- Must be able and willing to travel as required