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 intense research environment requires complex clinical research studies involving a very vulnerable and sick population. This position is responsible for managing key components of the 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.

 

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. 

The Oncology Clinical Research Manager 1 is responsible for direct oversight of clinical research activities within their designated OHSU Knight Cancer Institute clinical research program(s). Their responsibilities may include personnel management for employees in the clinical research organization, and/or management of finances associated with clinical research accounts and overall program budget, and/or program development in collaboration with program directors and investigators. In support of these activities, the Oncology Clinical Research Manager 1 is involved in continual process improvement to further the efficiency and effectiveness of the clinical research organization. 

 

The Oncology Clinical Research Manager 1 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.

 

Key responsibilities include: 

 

Personnel Management

• • Identify, hire, and onboard high-quality candidates who are committed to furthering the mission of the Knight Cancer Institute clinical research organization;

  • Collaborate with the Knight Clinical Trials 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.

• Program Development

  • Collaborate with Program Director in defining strategy of program development through evaluation of study portfolio, projecting resourcing needs, providing appropriate information/metrics and other support as needed.  Hold regular meetings with the Program Director for strategic discussions;

  • Communicate organizational information to the Program Director and team investigators in a timely manner;

  • Evaluate proposed studies to determine feasibility of conduct and ability to adequately resource in collaboration with Program Director, study team and finance team;

  • Collaborate with key stakeholders in the development of structure and resource allocations for new programs and initiatives;

  • Attend and lead (or delegate leadership) team meetings on a regular basis;

  • Represent the program with academic partners and industry collaborators;

  • Assess trial portfolio strategically to ensure continuity of research options across disease states.

• Fiscal Management

  • Collaborate on the development of and oversight of the group operating budget. Manage expenditures and revenue to budget.  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, and assist with trouble-shooting pre-award and post-award activities (invoicing, payments, and any problem situations etc.), as appropriate.

  • Collaborate with investigators and the Finance Team to create accurate and complete study billing schedules.

  • Conduct and/or facilitate billing review for appropriate charges.

• 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.

Education and experience:

Bachelor's and 5 years of relevant experience -or-

9 years of relevant experience, which must include at least 3 years clinical research experience.

 

Relevant experience must include at least 1 year supervisory or lead worker experience.

 

Knowledge, Skills and Abilities (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)

• Bachelor’s Degree or Master’s Degree

• Deep knowledge and experience with FDA, ICH GCP and other regulatory guidelines that govern clinical research

• Working knowledge of Access, EPIC, and/or Oracle

• Clinical research certification (SoCRA, ACRP)

Please be sure to include a resume or CV and cover letter with your application. 

 

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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.