Clinical Research Associate (East, MidWest, and SouthWest US)
One of our favorite Sponsor Partners is looking for several contract Clinical Research Associates to monitor a large Hema/Oncology study throughout the East, Midwest, and Southwest US. This is a long term contract and might be the perfect contract for you if you have experience monitoring Oncology or Hema Oncology studies, 50% availability, and are able and willing to travel.
- 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.
- Flexible with travel and near a major airport
- Oncology experience
- 50% availability
- Hema Oncology experience is a plus
- Autoimmune / MS experience is a plus