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.
The Oncology Clinical Research Supervisor will lead clinical research activities within their designated OHSU Knight Cancer Institute clinical research program(s). Their responsibilities may include supervising employees in the clinical research organization. They may assist the Manager with clinical research finance duties, and may participate in program development activities. In support of these activities, the Clinical Research Supervisor is involved in continual process improvement to further the efficiency and effectiveness of the clinical research organization.
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.
Function/Duties of Position:
The Clinical Research Supervisor is responsible for facilitating a caring and compassionate patient-focused experience and serves as a liaison between investigators and industry partners as well as other stakeholders within the institution.
Supervisor Responsibilities:
- First point of contact for the study team members regarding day to day operational aspects of clinical research to resolve issues and remove obstacles for study team members.
- Provide clinical research management coverage for study staff and vacant positions, as needed. This includes, but is not limited to, facilitating coverage for staff that is out of the office for planned time off, securing coverage for sick calls, serving as backup coverage when there are gaps, and escalating coverage gaps to the Clinical Research Manager.
- Meet with team members on a regular basis to monitor and assess workload and escalate identified issues to the Clinical Research Manager as needed.
- Facilitate and actively participate in new personnel training in collaboration with the Clinical Research Manager and Knight Trainer.
- Identify need for retraining of personnel or other needs for additional training in collaboration with Clinical Research Manager and Knight Trainer.
- Participate in process improvement and strategic initiatives.
- Keeps Clinical Research Manager appraised of overall project performance (i.e., staffing or resource needs, completion dates, changes/delays in scheduling, etc.) and study portfolio management.
- Identify process improvement opportunities, assess needs, implement solutions and evaluate effectiveness, in collaboration with Clinical Research Manager.
- Develop transition plans for on-boarding or off-boarding of staff, in collaboration with the Team Lead and/or Clinical Research Manager.
- Provide general input and recommendations on team resource needs (i.e., supplies, OHSU system access requests, equipment, etc) to Clinical Research Manager.
- Participate in the hiring and on-boarding of high-quality candidates who are committed to furthering the mission of the Knight Cancer Institute clinical research organization.
- Provide performance insight to the Oncology Clinical Research Manager, as appropriate.
- Evaluate workload allocation for staff members and groups in collaboration with the Oncology Clinical Research Manager, as appropriate.
Disease Group Program Development:
- Assist Clinical Research Manager with program development through evaluation of study portfolio, projecting resourcing needs, providing appropriate information/metrics and other support as needed.
- Communicate organizational information to the Clinical Research Manager and/or Program Director and team investigators in a timely manner.
- Assist in evaluation of proposed studies to determine feasibility.
- Attend and lead team meetings on a regular basis.
Fiscal Management:
May assist, participate or facilitate the following tasks:
- Regularly review program accounts and make projections for long-term planning.
- Collaborate with the Knight Clinical Research Finance Group in the development of appropriate budgets.
- Assist with trouble-shooting pre-award and post-award activities (invoicing, payments, and any problem situations etc.).
- Collaborate with investigators and the Finance Team to create accurate and complete study billing schedules.
Conduct and/or facilitate billing review for appropriate charges.
Clinical Research Coordinating Responsibilities:
- Assure appropriate conduct of protocol according to applicable regulations.
- Enroll patients in clinical trials.
- Obtain Informed Consent.
- Explain trial logistics.
- Review medical records for eligibility criteria.
- Schedule study required assessments.
- Process of human specimens for research.
- Obtain vital sign measurements for study patients.
- Document interactions with study subjects and vital signs as appropriate.
Data Management Responsibilities:
- Documentation: Complete case report forms/data entry.
- Create study calendars and shadow charts.
- Review medical record and extract relevant data.
Required Qualifications:
Education & experience:
- Bachelor's and 4 years of relevant experience OR 8 years of relevant experience, which must include at least 2 years of clinical research experience.
Knowledge, skills, and abilities:
- Strong understanding of clinical research requirements with regard to staffing, systems and processes.
- Ability to lead a group, serve as a mentor and/or facilitator, and create a positive work environment.
- Ability to ensure and deliver a customer service orientation that translates into timely and reliable support to staff, investigators, sponsor partners and other customers.
- Ability to set appropriate priorities and manage time.
- Excellent communication skills; ability to express and document ideas clearly and concisely in written communications; able to champion personal perspective while maintaining the ability to listen, comprehend, and adjust, when required, to other points of view.
- Self-starter with ability to work independently but collaboratively as part of a team.
- Strong critical thinking skills, problem-solving abilities, organizational skills and multi-tasking capabilities.
- Energy and drive to coordinate multiple projects simultaneously.
- Solution-oriented approach to issues.
- Ability to use tact and diplomacy to maintain effective working relationships.
- Proficiency in Microsoft Office programs (Word, Excel, and PowerPoint).
Preferred Qualifications:
- Deep knowledge and experience with FDA, ICH GCP and other regulatory guidelines that govern clinical research.
- Working knowledge of Access, EPIC, and/or Oracle.
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.
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.
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