Oregon Health & Science University 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. Therapeutic Intervential Senior Clinical Research Assistant US-OR-Portland Job ID: 2024-31497 Type: Regular Full-Time # of Openings: 1 Category: Research Portland, OR (Waterfront) Overview
Every Urology Research employee 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.
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.
Education
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.
Additional duties
Additional duties as assigned by OHSU Urology Research Manager
Responsibilities
Bachelor's Degree in relevant field AND 1 year of relevant experience OR
Associate's AND 3 years of relevant experience OR
4 years of relevant experience OR
Equivalent combination of training and 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 Excellent customer service, both on the phone and in person collaborative in resolving problems
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
Qualifications
Some clinical trial knowledge with 1 year of research experience
Experience with Microsoft Office, Access, and other networking and database systems