The mission of the Knight Clinical Research Management organization is to support the conduct of translational clinical research aimed at improving the lives of people and families with cancer by applying innovative strategies for cancer prevention, screening diagnosis and treatment.  The support is provided through proactive, high quality and efficient study management in compliance with federal regulations and local policies and procedures. This fast-paced and highly intense research environment require management of complex clinical research studies involving a very vulnerable and sick population. This position is responsible for managing the research team in the overall conduct of clinical trials using Good Clinical Practice and for tracking and complying with clinical trial performance benchmarks, patient safety, staff development and training, and financial goals.

The Lymphoma Program of the Knight Cancer Institute is seeking a Clinical Research Manager.  This program is driven by the work of 5 medical oncologists whose work seeks to improve the lives of patients with any type of lymphoma. This program is well-established and busy with trials ranging from First-in-human treatments to translational studies to gain a better understanding of cancer processes.

 

Position Summary:

The Clinical Research Manager is responsible for direct oversight of all clinical research activities within their designated OHSU Knight Cancer Institute clinical research disease program. The responsibilities for this role include personnel management for 8-20 employees in the clinical research organization, management of finances associated with clinical research accounts and overall organization budget, and disease group program development in collaboration with disease site leaders and investigators. In support of these activities, the Clinical Research Manager is involved in continual process improvement to further the efficiency and effectiveness of the clinical research organization. 

 

The Clinical Research Manager is responsible for creating 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.

 

Key responsibilities: 

Personnel Management

• Identify, hire and on-board high quality candidates who are committed to furthering the mission of the Knight Cancer Institute clinical research organization.
• Collaborate with the Knight Clinical Trials Office Trainer and assigned preceptor/mentor in training of new staff members and staff members who are undergoing re-training, as appropriate.
• Assess for and provide individualized professional development opportunities as appropriate and available for staff members.
• Assess equity and appropriateness of compensation as appropriate.
• Provide performance feedback to staff members on a regular basis that is timely, clear and actionable with documentation of that feedback captured when necessary.
• Evaluate workload allocation for staff members and groups and redistribute, as appropriate.  Provide back-up support for study management activities when necessary.

Disease Group Program Development

• Collaborate with key stakeholders in the development of structure and resource allocations for new programs.
• Attend disease group team meetings on a regular basis.
• Collaborate with disease group leader in defining strategy of disease group development through evaluation of study portfolio, projecting resourcing needs, providing appropriate information/metrics and other support as requested by the disease site leader. Hold regular meetings with the disease site leader for strategic discussions.
• Communicate organizational information to the disease site leaders and team investigators in a timely manner.
• Evaluate proposed studies to determine feasibility of conduct and ability to adequately resource in collaboration with disease site leader, study team and finance team.

Continuous Process Improvement

• Ongoing evaluation of processes and procedures for opportunities to improve through efficiency, quality checks or other improvement methods. Information that might be consider includes audit/monitor findings, observed process gaps and other mechanisms.
• Effectively communicate process improvement opportunities, engage key stakeholders, and solicit feedback/engagement.
• Ensure appropriate documentation of procedures and training of staff members to new/revised requirements.
• Assess outcomes of process changes to ensure the highest quality deliverables and most efficient approach.

Fiscal Management

• Collaborate on the development of and oversight of the group operating budget. Manage expenditures and revenue to budget. Regularly review budget reports for variances.
• Collaborate with the Knight Clinical Research Finance Group in the development of appropriate budgets, and assist with trouble-shooting pre-award and post-award activities (invoicing, payments, and any problem situations etc.), as appropriate.
• Collaborate with disease groups, investigators and the Finance Team to create accurate and complete study billing schedules.

Willingness to assume responsibility for tasks that may be outside of the formal job description, including those perceived as belonging to “lower pay grades” to get the job done. Completes other duties as assigned to fulfill the Knight mission.

 

Contributes to positive work environment and provides leadership in encouraging such an environment by personal example; maintains the highest ethical standards according to OHSU Policy, including the

 

Code of Conduct; maintains strict confidentiality of all sensitive, confidential, and/or proprietary documents and information.

Education and experience: 

• Bachelor’s degree -and- 5 years of relevant experience, including 1 year of personnel management experience.

Required competencies: 

• 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)

• Master’s Degree
• Clinical research experience
• Oncology clinical research experience
• Clinical research certification (SoCRA, ACRP)
• Deep knowledge and experience with FDA, ICH GCP and other regulatory guidelines that govern clinical research
• Working knowledge of Access, EPIC, and/or Oracle

Please be sure submit a cover letter and resume with your application. 

 

All OHSU employees are required to be fully vaccinated against COVID-19. Fully vaccinated means you have received both doses of a two-dose, or one dose of a single-dose, FDA- or WHO-authorized COVID-19 vaccine and at least 14 days have passed since your final dose of COVID-19 vaccine. If you apply for and are offered a position, you must be fully vaccinated prior to starting work. 

 

If the position you are offered does not require direct, in-person patient care contact, you may request an exception to the vaccine policy for medical or religious reasons. OHSU uses very narrow criteria under the law to allow an exception and very few requests are being approved. 

 

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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.


As an organization devoted to the health and well-being of people in Oregon and beyond, OHSU requires its employees to be fully vaccinated against COVID-19.