Description
Roles and Responsibilities:- Facilitates all operational activities pertaining to the execution of clinical trials
- Maintains regular internal contact with relevant departments such as Clinical Development, Clinical Science, Clinical Supplies, Regulatory Affairs, Drug Safety and others as necessary
- May manage the overall activities of CROs, central laboratory, and drug distribution center
- Responsible for the day-to-day interaction with multiple CROs in the execution of ongoing clinical trials
- Reviews monitoring reports, study invoices (Vendor, Site), tracks study progress, provides updates to Managers, Clinical Operations and maintains study files
- In conjunction with CRO monitors, mayconduct study initiation, routine site visits, and close-out visits
- Establishes study milestones and ensures accurate tracking and reporting if study metrics
Requirements:
- At least three years experience as a Clinical Research Associate (or a combination of one year experience as a Clinical Research Associate and two years in a comparable role) with increasing responsibilities in study management are preferred.
- Experience in management of multiple sites as a Clinical Research Associate is preferred.
- Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
- Oncology therapeutic area knowledge strongly preferred
- Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States.
- Travel may be required in the United States up to 20% in support of CRO activities
To find out more about Real please visit www.realstaffing.com