The OHSU Knight Cancer Institute is a pioneer in personalized cancer treatment and research, led by Dr. Brian Druker, whose development of Gleevec transformed Chronic Myeloid Leukemia from a fatal disease to a manageable one and proved that targeted therapies can work. The institute focuses on precision oncology, the early detection, prevention, and treatment of cancer, and creating a welcoming and supportive environment for its caregivers, researchers, and support personnel. Knight affiliates subscribe to three guiding principles: we are bold, we are supportive, and we work as a connected team in our fight to end cancer as we know it.  We’d love for you to join us!

 

The mission of Knight Clinical Research Quality & Administration (CRQA) is to foster a supportive environment conducive to achieving the Knight’s clinical research mission. CRQA provides a central location for policies, procedures, and systems to aid investigators and research groups with respect to trial development, execution, and oversight.

The Clinical Trials Auditor, utilizing deep regulatory knowledge and clinical research expertise, conducts audits to evaluate clinical research conduct to ensure research integrity and compliance with institutional policies, state and federal regulations, and Good Clinical Practice (GCP).  The Clinical Trials Auditor, utilizing clearly defined expectations and effective communication skills, provides direction and support to investigators to strengthen their research and ensure regulatory and protocol compliance. The Clinical Trials Auditor maintains a tracking system to ensure compliance with Knight Cancer Institute Data & Safety Monitoring Committee (DSMC) auditing requirements as outlined it the Knight Data & Safety Monitoring Plan (DSMP). The Clinical Trials Auditor oversees and helps implement other Quality Assurance (QA) initiatives of the Knight Cancer Institute and also provides guidance/mentorship to other quality assurance and clinical research staff.

 

As part of CRQA, this individual participates in formal and informal training relative to the position responsibilities described herein.  Through the course of fulfilling the responsibilities of this position, this individual will also identify and actively propose revisions to educational materials, toolkits and SOPs to ensure consistency in messaging related to processes, regulatory compliance and research integrity. This individual independently manages workload within Knight/CRQA service level understanding timelines and job description expectations.

Education & experience:

• Master's degree AND 3 years of relevant experience, OR
• Equivalent combination of Bachelor's degree in conjunction with training and experience.
• Relevant experience must include clinical trials coordination and/or clinical trials management.

Knowledge, Skills, and Abilities:

• Deep knowledge and experience with OHRP and FDA regulations governing clinical research and ICH GCP guidelines
• Excellent time management skills and ability to prioritize multiple tasks at one time
• Excellent communication, analytical and organizational skills: both written and verbal
• Detail-oriented while still seeing the “big picture”
• Solution-oriented approach to issues
• Self-starter with ability to work independently and as part of a team while being collaborative in resolving problems
• Proficient with computers running Windows and PC applications, e.g., Microsoft Office (Excel, Outlook, Access, Word, and PowerPoint) and Teams
• Ability to accurately type at least 60 wpm
• Demonstrated excellent customer service skills
• Possessing the energy and drive to coordinate multiple projects simultaneously
• Ability to use tact and diplomacy to maintain effective working relationships

• Degree in physical science and/or nursing
• Oncology-specific experience
• Investigator-initiated trial-specific experience
• Medical terminology
• ACRP or SOCRA certification
• RN license

For your application to be considered, please submit a cover letter specific to this position (Req 2023-22541).

 

 #knightcancerjobs #knightclinicalresearchjobs #knightresearchandlabjobs #knightresearchprojectjobs 

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.