Regulatory Project Coordinator - Military veterans preferred

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.


Regulatory Project Coordinator

US-OR-Portland

Job ID: 2025-34756
Type: Regular Full-Time
# of Openings: 1
Category: Research
Portland, OR (Waterfront)

Overview

This position is responsible for overseeing  regulatory components of oncology clinical research studies in support of the mission of the Knight Cancer Institute. The position has ownership of the  study maintenance processes and working with the associated teams. Over time the opportunity to learn the start-up process may become available.    The study start up process would include the tracking of clinical trials start-up metrics, communicating with all start-up process owners and participants, consent form development, CRRC and IRB submissions. 

  This position requires general supervision; innovation and problem solving required; facilitates the conduct of clinical research studies with good understanding and communication of study protocol requirements; above average time management skills.

Key Responsibilities:

• Expeditiously evaluate study modifications and other changes to the conduct of oncology studies to identify feasibility and all downstream impacts to systems in place to support oncology study conduct. Communicate applicable changes to responsible parties.
• Direct responsibility for preparation of all documentation required by the Knight CRRC and OHSU IRB, as appropriate for the study modification, in collaboration with the principal investigator. Maintain records on each study to ensure regulatory compliance with institutional policies and ICH/GCP guidelines.
• Actively manage all other regulatory obligations including preparing continuing review questionnaires (CRQs), unanticipated problem (UP) reports, protocol deviation (PD) reports, and reportable new information (RNI) reports in accordance with institutional policies, sponsor requirements and other regulatory requirements.
• Coordinate regulatory aspects of monitoring and auditing visits

Education & experience:

• Master's degree in relevant field and 1 year of relevant experience OR
• Equivalent combination of training and experience.

For the purposes of this position, a bachelor’s degree in any field will be considered relevant.

Knowledge, skills, and abilities:

• Working knowledge of FDA, DHHS and other agency guidelines that govern clinical research
• Ability to prioritize multiple tasks at a time.
• Must have 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.
• High level of organization, attention to detail, troubleshooting, and prioritizing skills
• Must be proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint. Typing 60wpm
• Must have demonstrated excellent customer service skills both on the phone and in person.
• Must possess the energy and drive to coordinate multiple projects simultaneously.
• Ability to use tact and diplomacy to maintain effective working relationships

• Master’s degree
• Bachelor's degree with coursework in science
• Project management training
• Two years clinical trials/research experience
• One-year regulatory experience
• Project management experience
• Experience using project management software (eg, MS Project)

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