The mission of the Knight Clinical Research Management organization is to support the conduct of translational clinical research aimed at improving the lives of people and families with cancer by applying innovative strategies for cancer prevention, screening diagnosis and treatment. The support is provided through proactive, high quality and efficient study management in compliance with federal regulations and local policies and procedures. This fast-paced and highly intense research environment require management of complex clinical research studies involving a very vulnerable and sick population.
The Knight Clinical Research Management organization is hiring a Clinical Research Coordination Team Lead in the area of Phase 1 clinical trials.
Key leadership responsibilities:
Oversees and manages the day to day operations of clinical research activities for studies conducted at the OHSU Knight Cancer Institute.
Oncology disease site knowledge expert for the teams that they lead.
Must have a strong understanding of how clinical and research operations work within the clinics/hospitals that their team works in and departments they collaborate with.
Must have the ability to cover all roles that they oversee.
Participates, with close collaboration of the disease site manager, in the strategic planning and financial management of the disease team they lead.
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, sets priorities for workload, and identifies opportunities for process improvement.
Manages coverage issues related to sick calls, vacation time, and may fill in to assist with responsibilities following a position vacancy. Does not maintain direct reporting responsibility for team members.
In addition to leadership responsibilities, the Team Lead maintains direct clinical research study management duties. Study management responsibilities include:
Coordination of all aspects of a study as specifically outlined in the protocol and compliance with applicable regulations, including Good Clinical Practice.
Works collaboratively with physician, nursing, and ancillary staff in the scheduling and management of subject research activities.
Maintains accurate, complete and timely records on research subjects which may include preparation of source documentation and clinical research data/case report forms.
Represents the investigator during monitor visits and on-site audits conducted by the sponsor or sponsor representative.
Assists the Regulatory Project Manager with the IRB submission, to include preparation of consent forms and other documents required for IRB review.
Maintain a working knowledge of FDA, DHHS and other agency guidelines that govern clinical research.
Requires only occasional supervision; Prior study management and clinical research coordination skills plus exercises sound judgment in taking independent action and seeks to advise as appropriate; assists in process improvement efforts; demonstrates strong problem-solving skills; responsible for training and providing oversight of junior staff; assists leadership in the implementation of research program goals.
Masters degree with major courses in the relevant field and three years of relevant experience -OR-
Bachelor's Degree (4 yr) with major courses in the field of research and five years of relevant experience. (per attached Knight PDM)
Strong understanding of research regulations and best practices
Strong data abstraction skills
Strong project management skills
Ability to prioritize multiple tasks at one time
Excellent communication, both written and verbal
Strong analytical and organizational skills
Ability to work independently and as part of a team while being collaborative in resolving problems
Proficiency with computers running Windows, PC applications, and the Microsoft Office suite, e.g., MS Excel, Outlook, Access, Word, and PowerPoint
Excellent customer service skills both on the phone and in person
Energy and drive to coordinate multiple projects simultaneously
Ability to use tact and diplomacy to maintain effective working relationships
Bachelors or Masters degree with coursework in science. Prior experience with Knight Clinical Research Management department. Some clinical research knowledge with a minimum of 5-years of research experience. Experience working in an office environment. Familiarity with medical terminology. High level of organization, attention to detail, troubleshooting, and prioritizing skills is preferred. Prior experience supervising direct reports OR mentoring junior staff
Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or firstname.lastname@example.org.
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