Description
Roles and Responsibilities:- Assist in managing all aspects of clinical trials to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
- Assist with the management of key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, site feasibility, database lock, etc.) and proactively identify solutions within the clinical team when issues arise
- Develop and review informed consent forms, case report forms, study manuals, and other clinical trial materials
- Review and provide input on regulatory documents and Clinical Trial Application documents
- Perform site qualification, initiation, interim monitoring and close-out visits as needed
- Perform co-monitoring visits/Sponsor Oversight Visits as required/requested
Requirements:
- Bachelor's degree in a scientific discipline or health-related field
- Minimum of 5 years clinical research experience and at least 3 years experience as a CRA in a biopharmaceutical company or CRO
- Previous experience with Global oncology clinical trials is strongly preferred (Ovarian experience helpful)
- Demonstrated proficiency in implementing, monitoring and management of clinical trials, from start-up to close-out. Experience with working on global trials a plus
- Strong Knowledge of FDA regulatory requirements and ICH/GCP guidelines
To find out more about Real please visit www.realstaffing.com