This position is a collaboration between OHSU Knight Cancer Institutes’ Cancer Early Detection Advanced Research Center (CEDAR) and OHSU’s Department of Urology. The Department of Urology will support the research goals of the collaboration. We are seeking a highly motivated, detail oriented Clinical Research Assistant (CRA) to aid in the collection, transport, and storage of biological samples and data. This position will support projects directed by urologic oncology providers across OHSU and the Portland VA Medical Center. This position requires someone who is trained in or willing to be trained in phlebotomy, and become certified within the first 6 months.

 

The CRA is responsible for the overall management of CEDAR and OHSU Urology’s early detection clinical trial alongside the PI and repository leadership. This includes working with the regulatory management team to complete 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. The CRA may have direct patient contact, collect and process biological samples. The CRA 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.

 

The CRA will operate under supervision of the Urology research manager. The CRA will work closely with urologic oncology providers and laboratory staff at OHSU and the Portland VA Medical Center as well as research staff within CEDAR.

 

CEDAR and the Department of Urology are 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 Urology Research employee partnering with Knight Cancer is expected to embody Knight Cancer’s guiding principles:

• We act BOLDLY—Breakthroughs require pushing the boundaries of science, exploring new frontiers, and thinking differently.
• We SUPPORT each other—Respect 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.

Clinical Trial coordination

• 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.

Participant Coordination

• 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.
• Perform study recruitment and enrollment, including telephone contact with participants and obtaining consent for research studies.
• Procure and process human biological specimens (to including blood, urine, tissue, 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.

• Bachelor's in relevant field OR
  • Associate's AND
  • 2 years of relevant experience OR
  • 3 years of relevant experience OR
  • Equivalent combination of training and experience
• Some clinical trial knowledge with 1 year of research 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
• Ability to become phlebotomy certified within the first 6 months
• Keen attention to detail
• Strong trouble shooting skills

• Compliance with Code of Conduct, Respect in the workplace and Applicable policies, procedures and agreements related to position, department or OHSU as a whole

• Must be able to perform the essential functions of the position with or without accommodation

• Experience with Microsoft Office, Access, and other networking and database systems
• Experience with medical terminology
• CCRP or ACRP Certified
• Phlebotomy certification

Pay Range: $18.91 - $28.37 per hour (Commensurate with qualifications, experience and internal equity)

• Mon-Fri (Hybrid) 8:30-5
• Must be able to travel to multiple worksite locations on campus, including using the tram
• Coordinator will work with human biological samples, including samples which may contain infectious disease
• Coordinator will be expected to travel to conferences, new study meetings, and may travel for study monitoring at other sites
• Position will require occasional weekend work and ability to focus in a busy cubicle environment with multiple distractions
• Candidate must be able to tolerate a busy environment where multi-tasking is necessary; handle human specimens; work in an environment with constant interruptions; lift and carry up to 20lbs; tolerate extended periods of sitting, standing, and walking.

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 aaeo@ohsu.edu.