Senior Clinical Research Associate

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
* Develop and review informed consent forms, case report forms, study anuals, and other clinical trial materials
* Assist in the evaluation and management of CROs and other vendors and systems. Negotiate and manage contracts/budgets with CROs and other vendors
* Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality
* 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
* Plan, coordinate and present at Investigator Meetings and CRA Training meetings as requested
* Support internal and regulatory audits of clinical trial sites and vendors and assist with resolution of audit findings

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
* Strong Knowledge of FDA regulatory requirements and ICH/GCP guidelines
* Demonstrated proficiency in implementing, monitoring and management of clinical trials, from start-up to close-out. Experience with working on global trials a plus
* Previous experience with Global oncology clinical trials is strongly preferred (Ovarian experience helpful)
* Willingness to travel as necessary, consistent with project needs ***
To find out more about Real please visit www.realstaffing.com