Description
Roles and Responsibilities:- Daily activities will vary depending on the clinical phase of the program. Will have responsibilities for managing one or more projects. Determine methods and procedures for performing new assignments. Oversee the activities of CTAs and CRAs.
- Manage contract research organization (CRO) personnel and study sites to ensure studies are completed on time, within budget and in compliance with the protocol, GCPs, FDA regulations and ICH/GCP guidelines, and overall clinical objectives.
- Manage all study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out.
- Supervise on-site monitoring visits, including site qualification, initiation, interim, co-monitoring with CRO, and close-out visits. Review site visit reports.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
Requirements:
- BA/BS in a scientific or healthcare discipline
- TRAVEL: 50-60 % required with sites all over North America (US and Canada)
- 3+ years of clinical monitoring in areas with complicated implications
- Experience running clinical trials with oncology and/or neurology/cardiovascular
- Strong verbal and oral communication skills
Currently working on TWO projects:
1. spinal cord injury
2. macular degeneration
To find out more about Real please visit www.realstaffing.com