The OHSU Knight Cancer Institute, known as one of the pioneers in personalized cancer medicine, is an international leader in research and cancer treatment. Driven by its mission to end cancer as we know it, the institute is building upon its expertise in targeted treatments to advance the early detection of cancer when the disease is most treatable. Cancer Early Detection Advanced Research Center (CEDAR) is a highly collaborative institution within the OHSU Knight Cancer Institute. At CEDAR our mission is to detect and stop lethal cancers at the earliest stage because early detection saves lives. This is an ambitious goal, one that requires novelty, creativity, and innovation. We conduct groundbreaking translational cancer research to help people maintain a high quality of life and reduce cancer mortality, to create a global early detection community, and to have a positive impact on the Oregon economy. Our clinical trials are cutting edge and laser focus on the exciting and rapidly evolving area of cancer early detection.
CEDAR is committed to increasing the diversity of the campus community. We are dedicated to promoting inclusion and multiculturalism to build a successful organization by having outstanding researchers of diverse backgrounds work together.
Every Knight Cancer employee is expected to embody our guiding principles:
We act BOLDLYBreakthroughs require pushing the boundaries of science, exploring new frontiers, and thinking differently
We SUPPORT each otherRespect leads to trust, which leads to excellence
We work as a CONNECTED team We must leverage our collective brain power to conquer cancer because no one individual can do it alone
The CEDAR Clinical Research Coordinator is responsible for the overall management of early detection clinical trials. This includes working with the regulatory management team to complete all regulatory documentation required by the OHSU IRB and sponsor, creation of study calendars and flow charts, assisting in the verification of patient eligibility, development of data collection instruments and consent forms, data entry, assurance of conduct of protocol in accordance with applicable NCI and FDA guidelines, maintenance of study patient records and source documentation, coordinating orders and study drug with the clinical team, ensuring that patient billing is accurate and assisting manager and financial team in verifying appropriate clinical trial billing. The study coordinator may have direct patient contact, process biological samples and may perform other non invasive testing such as ECGs. The study coordinator will also assist in the continuing education of physicians, residents, interns, nurses and other related personnel with regards to knowledge of clinical trials and activities.
Clinical Trial coordination
Strong understanding of research regulations and best practices. Responsible for coordinating many aspects of clinical trials from startup to closeout and assuring conduct of trials in accordance with NCI and FDA guidelines.
Ensure compliance with FDA and regulatory reporting agencies. Report any non-compliance to study investigator / departmental staff. Prepare any necessary materials for required internal and external (sponsor, FDA) regulatory and quality control audits and sponsor monitoring visits.
Work with regulatory management team to adhere to regulations at OHSU for initial and continuing regulatory approval of clinical protocols such as annual re-approval/continuing review, amendment approval; and submission of reportable information.
Be knowledgeable about clinical research protocols and protocol requirements.
Distribute clinical research related information to appropriate research team / affiliated institutional personnel as applicable. Notify research team and those individuals directly involved in in pertinent areas of clinical research of protocol amendments, revisions, activations, closures and announcements.
Keep local Principal Investigator up to date on key information as related to the clinical research. Schedule and maintain records on appropriate trainings/meetings as needed.
Review patient data to determine appropriate eligibility and deficiencies regarding enrollment into clinical trials.
Confirm with investigator that subject meets appropriate inclusion criteria for clinical trial. Communicate all pre-treatment requirements to investigator/clinical staff.
Procure and process human biological specimens (to include blood, urine, etc) in adherence with protocol parameters and appropriate training. Obtain and submit imaging studies, pathology samples as required by sponsor to appropriate reviewers as required by protocol. Obtain and submit Review and report adverse events or Unanticipated Problems to IRB/study sponsor.
Perform data entry and chart review/abstraction to verify that key data has been reported to the clinical research database or reported to the sponsor in the required format. Review follow up data clarifications or data queries and report within study timeline. Maintain and update subject data for study analysis and survival. Assist investigators with any special requests for data retrieval and/or evaluation and analysis of clinical data for ongoing research studies.
Participate in continuing education activities within the research program and other areas to maintain current knowledge of disease process, research regulatory requirements, and process improvements for clinical trials.
Assistance and training for more junior staff.
Additional duties- Additional duties as assigned by Clinical Research Manager
Bachelors Degree (4 yr) with major courses in field of research and 1 to 3 years of relevant experience
Experience conducting different phases of projects, including data collection and 1+ years of clinical trial experience
Ability to prioritize multiple tasks at one time
Excellent communication, analytical and organizational skills: both written and verbal
Ability to work independently and as part of a team while being collaborative in resolving problems
Excellent customer service, 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
Keen attention to detail
Strong trouble shooting skills
Experience with Microsoft Office, Access, and other networking and database system
Experience with medical terminology
Apply online. Please be sure to upload a Cover Letter and Resume/CV.
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 email@example.com.
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