工作內(nèi)容：
1.Provide study management at site level for regulated and/or post-market studies to ensure successful conduct of clinical programs in accordance with Zimmer Biomet policies, standard operating procedures and related regulations. Maintain clinical trial files to ensure compliance with internal standard operating procedures and local regulations.
2.Perform site qualification, initiation, monitoring, closeout and site audits. Conducts or oversees clinical site visits including site selection to ascertain potential investigator interest and feasibility to participate in a study, site initiation and training as well as general oversight to evaluate the performance/compliance levels of site and take appropriate action necessary to resolve any issues of noncompliance. Review and manage study payments and reimbursements. Coordinates and facilitates development of peer-reviewed manuscripts and reports on data received. Follow up with clinical sites to ensure all required actions, follow-up items and requests for additional information are completed in a timely manner. Review study case report forms (CRFs) completed by the investigative sites and verify entries by validating accurate source documentation to support CRF entries.
3.Review and provide input to improve clinical operations efficiency. Implement and track relevant key performance indicators to assess the performance of clinical operations and ensure the deliverables from the clinical projects are met in accordance with the agreed plan. Ensures adherence to study timeline and budget. Maintain internal records of site budgets, payments, and device accountability.
4.Identify, build and leverage effective working relationships with external physician advisors and clinical investigators and applicable research staff. Serve as technical and scientific resource to study site staff, investigators, sales representatives, and other staff members regarding investigational products and study protocol.
5.Participate in the design and development of key clinical study documents (e.g. study protocol, informed consent forms and monitoring plans) ensuring that the study will produce sound and relevant clinical data to support the business needs; seek input as needed from cross-functional team members. Serve as Super User/Administrator responsibilities for systems (e.g. Clinical Trial Management System, SharePoint, Project Master Folder).
職位要求:
?A bachelor’s degree or higher in the clinical medicine, life sciences, engineering or related disciplines.
?Minimum of 1 year experience in clinical research (preferably as a CRA in device trials/studies) in China.
?Thorough knowledge of international guidelines and local regulations in the conduct of clinical research especially in medical devices.
?Good knowledge in clinical research methodology and processes from the set up to completion phase of clinical research projects.
?Good technical knowledge in the field of orthopedics and orthopedic implants is advantageous.