Clinical Research Associate – Bone Marrow Transplant (US)
One of our partners has an immediate need for multiple CRAs to monitor sites located throughout the US, (site assignments will be based off your location however travel flexibility is needed). Qualified candidates will have a minimum of 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.
- Recent experience monitoring at least one of the following therapeutics: Neurology, Infectious disease/vaccine, Oncology with Bone marrow transplant as a treatment, Ophthalmology, Rare diseases, or Diabetes
- Utilization: Commitment of at least 50%
- Long term contract as our client is looking for a long-term relationship with you
- Must be able and willing to travel as required for monitoring visits
- Experience in a Site Management role preferred
- Experience monitoring federally funded studies preferred, (especially for site retraining for sponsor studies)
- Comfortable with Risk-Based Monitoring