Research Project Coordinator - Oregon Health & Science University
Portland, OR
About the Job
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 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
This position is responsible for assisting in all regulatory components of cancer early detection clinical research studies in support of the mission of the Knight Cancer Institute and CEDAR. Along with the senior Regulatory Project Coordinator, the position has ownership of the oncology early detection study start-up process, including the tracking of oncology early detection clinical trials start-up metrics, communicating with all start-up process owners and participants, consent form development, CRRC and IRB submissions and all communications/ responses, CTRP registration workflows, Florence eRegulatory and eConsent build and maintenance, clincard setup and flowsheet updates. In addition, the position also input the feasibility assessments, has oversight on essential regulatory document completion, eCRIS, subsite regulatory coordination, and coordination of monitoring visits along with assigned primary coordinator. The position also has ownership of all regulatory tasks that must be completed over the lifetime of the oncology early detection clinical research studies they support, including the processing of protocol amendments, investigator brochures and safety reports, consent form updates, and applications for continuing approvals.
Additionally, this position will oversee the implementation and evaluation of our non-interventional trials portfolio, to include research protocols recruiting newly diagnosed cancer patients, and patients who are involved in cancer screenings. This role is essential in establishing networks and connections with other OHSU departments to ensure effective recruitment efforts by gaining access to patient cohorts and encouraging referrals, organizing the clinical trial team in efforts to maximize recruitment through improvement and development of infrastructure, electronic tools, and resources available to the team.
The successful candidate will have and maintain a working knowledge of FDA, DHHS and other agency guidelines that govern clinical research. Strong organizational, interpersonal and writing skills are required. Ability to clearly organize and/or adapt to multiple priorities and tight deadlines at one time is necessary. Attention to detail, strong understanding of the scientific method, project management, customer service, and critical judgment skills are essential. Requires limited supervision; innovation and problem solving required; facilitates the conduct of clinical research studies with excellent understanding and communication of study protocol requirements.
Key Responsibilities
- Promotes the mission of the Knight Cancer Institute and CEDAR through Professional Standards of Customer Service, Reliability, Productivity, Professionalism, Accuracy, Timeliness, and Problem-Solving.
- Active regulatory management of oncology early detection clinical research study from activation to close out.
- Drive the oncology early detection study activation process in alignment with Knight Start-up Initiative timelines. Effectively manage expectations, timelines and deliverables. Use clear and consistent communication with progress and target timelines to facilitate completion of all required steps in an efficient and timely manner. Proactively anticipate, identify and address obstacles/issues, escalating to disease study team, manager, and PI as appropriate.
- Direct responsibility for preparation of all documentation required by the Knight CRRC and OHSU IRB, in collaboration with the principal investigator, including creation of the informed consent. Active management of oncology early detection submissions throughout the review process. This role is responsible for prompt responses and coordination of all communications with the review boards, sponsor and other involved parties (e.g., IND/IDE Associate). Updates study tools (trackers, flowsheets, VIA Oncology) as needed. Maintain records on each study to ensure regulatory compliance with institutional policies and ICH/GCP guidelines.
- Oversight of the processes required for oncology early detection study activation by coordinating with parties directly responsible for deliverables including but not limited to feasibility evaluation, eCRIS study build, clincard startup, regulatory document collection, protocol analysis to inform budget negotiations, contracts clarifications as requested, subsite regulation and compliance, and training of junior staff.
- Expeditiously evaluate study modifications and other changes to the conduct of oncology early detection studies to identify feasibility and all downstream impacts to systems in place to support oncology early detection study conduct.
- Non-Interventional Study Oversite. Oversee Cancer recruitment team facilitating biweekly meetings to review processes and ensure that all studies have stated recruitment goals we are actively working toward.
- Maintain a list of referral sources and identify gaps in recruitment from disease groups. Connect with PI, and various disease groups within OHSU to generate lasting patient referral systems.
- Creation and implementation of SOP’s and training materials, hosting group trainings and one on one’s as necessary.
- Implement new cancer recruitment screening and tracking systems.
- Fax and obtain records from outside institutions for regulatory source documentation.
- Study Lead for Adela CAMPERR study
- Conduct Bi-weekly sponsor meetings regarding enrollment goals, cohort status, recruitment barriers, and study updates.
- Update study specific EPIC smart phrases and screening criteria.
- Coordinate and attend monthly coordinator calls.
- Organize remote monitoring visits every 6 weeks, including scheduling, providing access for CRA, resolving queries, and following up on findings.
- Communicate study updates and changes to the team.
- Improve recruitment advertising and techniques.
- Efficiently track and schedule Tier 1 and Tier 2 participant follow-up draws.
- Serve as the primary contact for Columbia Memorial Clinic draws.
- Screen all newly diagnosed cancer patients referred or identified for study eligibility using advanced oncological and medical terminology to assess patient eligibility.
- Upload and track patients in Redcap participant tracker on weekly basis.
- Conduct initial recruitment calls, educating patients on the study and participation requirements.
- Schedule patients for virtual or in-person visits when available.
- Coordinate all necessary follow-up with the team and patients.
- Information Technology, responsible for creating databases to organize studies for efficiency and to display information to study team and investigator using a range of software available at OHSU, (i.e Qualtrics, Smartsheets, Redcap)
- Research coordinator duties: Oversight and conducting Virtual research studies across the greater Portland metro area and additional areas as study presence grows.
- Assist with training of junior Regulatory Project coordinators, Study coordinators and Student Workers.
- Additional duties as assigned by Clinical Research Manager or Program Director.
Education & experience:
- Bachelor's in relevant field AND 1 year of relevant experience OR equivalent combination of training and experience
Knowledge, skills, and abilities:
- Ability to prioritize multiple tasks at one 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 energy and drive to coordinate multiple projects simultaneously
- Ability to use tact and diplomacy to maintain effective working relationships
- Master’s degree
- Project management training or certification
- 1 year regulatory experience
- Project management experience or certification
- Oncology experience
- Experience using project management software (eg, MS Project)
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: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.