Description
My client is a medical device company in the Bay Area and the product has CE Mark and is commercialized in Europe. The FDA has approved an IDE clinical pivotal study in the United States. They are seeking a Sr. CRA to become a member of their organization.Main Responsibilities:
- Plan and execute on clinical study start-up, including site qualification, IRB/Ethics Committee applications, site contracts, site initiation and training
- Ensure compliance with regulations, SOPs, and protocols by training and guidance of clinical site personnel, and conducting periodic on-site evaluations and follow-up of corrective actions
- Participate in developing and writing clinical protocols, case report forms, and site training materials
- Monitoring and tracking clinical study data (CRFs, source documents, etc.) to identify and resolve discrepancies, and ensure compliance with regulations and protocols.
- Assist in the development and management of clinical databases. This may include data entry.
- Maintain and control all necessary study documentation according to procedures and regulations.
- Identify, report and ensure adequate follow-up of adverse events
- Ensure proper investigational product supply, accountability and storage during assigned clinical studies
- Assist with the management of CROs and vendors with respect to scope of work and project timelines.
- Act as clinical cross-functional team member to assist R&D, quality and regulatory to meet company timelines and objectives
Education / Experience required:
Bachelors Degree, Life Sciences preferred. Minimum of 4 years relevant clinical research experience, preferrably in spine or orthopaedics medical devices. Excellent organizational, interpersonal and communication skills. Must be able to manage multiple tasks and work with limited direction while generating quality project deliverables. Must be able to travel up to 50%, including international travel.
To find out more about Real please visit www.realstaffing.com