Sr. Clinical Research Associate
San Francisco Bay Area
Urgently looking for a Sr. Clinical Research Associate with experience working on Medical Device trial. The client is a seeking a professional who can participate in clinical research programs by assisting with the development of study protocols, case report forms, clinical reports; performing clinical on-site case support, site monitoring visits; and interfacing with site coordinators, Clinical Research Organizations (CRO), and other company representatives.
- Ensure that documentation from investigators and investigational sites meets FDA/ ICH GCP/ISO 14155 requirements.
- Assist in designing, planning, and implementing clinical research projects
- Assist in the design of study protocol, case report forms, informed consent for sound and thorough data to support the device through the approval process.
- Review study records including case report forms, consent forms, and other materials.
- Assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements.
- Organize data in systematic manner to allow for efficient and accurate clinical reports.
- Perform site visits to ensure regulatory and study requirements are being fulfilled.
- Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols; including surgical case coverage.
- Assist in writing the clinical portion of Regulatory submissions.
- Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities.
- May oversee the work of Clinical Research Associate I, II and Clinical Trials Assistant.
- Perform other clinical duties when requested.
- Computer proficiency in Microsoft Office required.
- Maintains trained status for, and complies with, all relevant aspects of the clients Quality Management System to ensure product quality and support regulatory compliance.
- Understands and adheres to the clients Quality Policy.
- Must be willing to travel up to 35 to 50% of time
Education & Experience:
- Bachelor's degree in a scientific or health care discipline preferred and /or training
- 5+ years' recent experience in the role of Clinical Research Associate
- Four to six years' experience in the medical device industry with involvement in clinical research activities preferred.
- Effective clinical monitoring skills
- Excellent understanding and demonstrated application of GCP and applicable SOPs
- Prior experience managing CRO's and study sites