Description
Overview:SR CRA will participate as a clinical team member in the management and execution of investigational trials to fulfill program/corporate goals, and oversee monitoring activities for investigational trialsResponsibilities:
- Provide guidance, clinical trial management expertise, and direction to contract and/or CRO CRAs including trip report review, telephone contact report review, co-monitoring, and mentoring
- Develop strong relationships with clinical trial sites
- Perform site monitoring visits (pre-study, initiation, interim, and close-out) and provide visit reports in a timely manner
- Contribute to SOP and TMF development
- Monitor safety surveillance and reporting activities
- Assist with the oversight and management of central labs and other vendors as applicable
Requirements:
- BA/BS degree in scientific discipline, RN or BSN degree
- 6+ years experience in the clinical research industry
- 2+ years as a clinical monitor
- Knowledge of ICH-GCPs and 21 CFR is required
- Experience with EDC is required
- Experience with international trials preferred
To find out more about Real please visit www.realstaffing.com