Regulatory Project Coordinator
Regulatory Project Coordinator
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Job Description
Department Overview
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.
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 teamWe must leverage our collective brain power to conquer cancer because no one individual can do it alone
Function/Duties of Position
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
Required Qualifications
Education & experience:
- Masters degree in relevant field and 1 year of relevant experience OR
- Equivalent combination of training and experience.
For the purposes of this position a bachelors 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
Preferred Qualifications
- Masters degree
- Bachelors 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)
Additional Details
Apply online. Please be sure to upload a Cover Letter and Resume/CV.
We offer a variety of benefits on top of joining a thriving organization:
- Medical dental and vision coverage at no or low cost to employees
- Covered 100% for full-time employees and 88% for dependents
- Several retirement plans to choose from with contributions from OHSU
- 25 days a year of paid time off
- 8 days of sick time off
- Commuter subsidies
- Tuition reimbursement
- Access to group life insurance disability insurance and other supplemental benefits
- Annual Merit Increase
- Growth/Development Opportunities
- Employee discounts to local and major businesses
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All are welcome
Required Experience:
IC
Employment Type
Full-Time
