The Clinical Research Coordination Team Lead oversees and manages the day-to-day operations of clinical research activities for studies conducted at the OHSU Knight Cancer Institute. The Team Lead is the first point of contact for the study team members regarding operational aspects of clinical research, to resolve issues and remove obstacles for study team members, set priorities for workload, and identify opportunities for process improvement. The Team Lead will also manage coverage issues related to sick calls, vacation time, and may fill in to assist with responsibilities following a position vacancy. The Team Lead does not maintain direct reporting responsibility for team members.
In addition to leadership responsibilities, this individual maintains direct clinical research study management duties. Study management responsibilities include the coordination of all aspects of a study as specifically outlined in the protocol and compliance with applicable regulations, including Good Clinical Practice.
The Team Lead will also:
Work collaboratively with physician, nursing, and ancillary staff in the scheduling and management of subject research activities
Maintain accurate, complete, and timely records on research subjects which may include preparation of source documentation and clinical research data/case report forms
Represent the investigator during monitor visits and on-site audits conducted by the sponsor or sponsor representative
Assist the Regulatory Project Manager with the IRB submission, to include preparation of consent forms and other documents required for IRB review
Have and maintain a working knowledge of FDA, DHHS and other agency guidelines that govern clinical research
Assist in process improvement efforts
Train and provide oversight of junior staff
Assist leadership in the implementation of research program goals
As the state's only health and research university, OHSU brings together patient care, research, education of the next generation of health care providers and scientists and community service to improve the health and well-being of all Oregonians.The university is a conduit for learning for more than 2,800 students, providing training to interns, residents and fellows in postgraduate medical and research. It is the only place in Oregon that grants doctoral degrees in medicine, dentistry and nursing. OHSU cares for more than 251,000 patients each year from around the region and takes a leadership role in contributing to solutions involving the health of the state and the nation, such as health care access and transparency, ethics and workforce shortage. Beyond providing critical health care services, quality education and cutting-edge research, OHSU also is a key economic and social force in the Northwest. With an annual operating budget of $2.06 billion and more than 14,000 employees, OHSU is Portland?s largest employer. Its size contributes to its ability to provide... many services and community support activities not found anywhere else in Oregon. For more information visit http://www.ohsu.edu/xd/about/index.cfm