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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 mission of the Knight Cancer Clinical Research (KCCR) 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.

The Clinical Research Monitoring Program is one of several investigator-initiated trial (IIT) specific support programs within KCCR.

Function/Duties of Position

OHSU Research classification: Research Project Manager, represented by the Research Workers United (RWU), subject to the active collective bargaining agreement between OHSU and RWU. Internally referred to as Clinical Research Monitor.

Position Summary:

The Clinical Research Monitor, as a member of the Clinical Research Monitoring Program, is considered a centralized resource, reporting directly to a KCCR Assistant Director, and as assigned, working in support of OHSU investigators conducting cancer-related research under an IND or IDE. When an individual holds a regulatory application (i.e. IND or IDE) with the Food and Drug Administration (FDA), they are considered the regulatory 'sponsor' and are responsible for adherence to all federal regulations applicable to the sponsor, one of which is regular quality control (QC) monitoring of the investigation.

The Clinical Research Monitor, utilizing clearly defined expectations and effective communication skills, contributes to the development and maintenance of Trial-Specific Monitoring Plans (TSMPs) and evaluates the conduct of clinical trials accordingly on behalf of the sponsor to ensure research integrity and compliance with the protocol, institutional policies, state and federal regulations, and Good Clinical Practice (GCP) guidelines.

This individual participates in formal and informal training relative to the position responsibilities described herein. Through the course of fulfilling the responsibilities of this position, this individual will also identify and actively propose revisions to educational materials, toolkits and SOPs to ensure consistency in messaging related to processes, regulatory compliance and research integrity. This individual independently manages workload within KCCR/Monitoring Program service level understanding timelines and job description expectations.

 Duties & Responsibilities:

MONITORING AND TSMP SUPPORT

For studies utilizing the monitoring support program, as assigned and under direction from the trial sponsors:

• Contributes to the development and maintenance of trial-specific monitoring plans (TSMPs).
• Independently organizes monitoring activities within KCCR service level understanding, regulatory timelines and approved TSMPs.
• Collaborates with sponsors and research teams to ensure transparency in the monitoring process and a respectful and efficient review from initiation to final confirmation that resolutions have been implemented.
• Conducts monitoring visits to ensure compliance with the IRB approved protocol as well as compliance with all regulatory requirements, institutional policies, and NCI policies relating to human subject research according to the approved TSMP. This entails visit preparation, scheduling, communications, review of regulatory documentation, review of subject source documentation, and review of investigational product accountability records, and involves the use of critical thinking and clinical judgment (if applicable) to assess findings and serve as a resource to the sponsor and team. Visits may involve one or more meetings with the sponsor, investigator (if different), and research staff. Ultimately, each visit culminates in the compilation of a clear and concise monitoring report documenting all relevant findings.
• Serves as a resource for sponsors and research teams regarding monitoring program findings or other quality/compliance issues, providing recommendations for resolution or future prevention.

QC PROGRAM ADMINISTRATION:

The Clinical Research Monitor contributes to the management of the QC Program through the following administrative and strategic functions:

• Develops and maintains a detailed tracking mechanism [e.g. spreadsheet or database] to document all aspects of monitoring program data; i.e. monitoring dates, activities, findings, action items, due dates, etc.
• Develops processes, policies, materials, and documentation for this position and continuously updates as appropriate.
• Collaborates on development of both internal and external guidance documents, policies, and practices to improve compliance by sponsor, investigators and research teams.
• Serves as a resource to provide guidance/training to research team members as questions/issues arise relative to the monitor role.
• Participates as a member on additional committees, as assigned and as time allows (e.g., Knight Data & Safety Monitoring Committee, etc.)
• Collaborates and contributes to the success of the Knight Cancer Clinical Research Strategic Plan, as appropriate.

OTHER RESPONSIBILITIES:

• As a member of OHSU and the KCCR group, this individual participates in and contributes to team meetings and huddles, Knight-wide meetings, inter-departmental collaborations, process improvement initiatives, mentorship, and professional development activities as applicable to the role.
• This individual also remains current on OHSU-wide updates, fulfills all OHSU requirements necessary for ongoing employment, and is otherwise welcome to engage in OHSU-wide initiatives, within reasonable limits.
• This individual may also provide back-up support to other KCCR positions/activities as needed for coverage purposes, understanding this may mean a temporary shift in FTE distribution of duties.

Working Conditions:

• Typical schedule: M-F, with occasional nights and weekends to meet project-specific deadlines.
• Work schedule may vary depending on job/study requirements and flexibility can generally be accommodated.
• Work unit is located on OHSU South Waterfront. Position is remote work eligible, though must be available to work on campus as needed (for example, when study records are only available in hard copy format).
• When on campus, some travel between meeting locations on OHSU's main campus may be necessary, including use of the Portland Aerial Tram.
• As assigned, conducts monitoring visits at external locations, which may include travel within the continental United States. Extent of travel may be as much as 50%. Use of an institution-issued procurement card and management of expenses within travel policies is expected.

Required Qualifications

Education & Experience:

• Master's degree AND 3 years of relevant experience, OR
• Equivalent combination of Bachelor's degree in conjunction with training and experience

Relevant experience must include:

• Experience coordinating and/or managing clinical trials

Knowledge, Skills & Abilities:

• Strong knowledge of GCP, FDA and other agency guidelines that govern clinical research. Ability to translate knowledge into policies and practices
• Experience in regulatory management of clinical trials (planning, amendments, annual reviews, etc.)
• Proficiency with computers running Windows and PC applications (e.g., Word, Excel, Oracle, Access, and PowerPoint).
• Excellent record of time management and setting appropriate priorities
• Excellent communication skills; ability to express and document ideas clearly and concisely in written communications; able to champion personal convictions while maintaining the ability to listen, comprehend, and adjust, when required, to other points of view.
• Self-starter with ability to work independently and collaboratively as part of a team
• Demonstrated ability to establish and maintain effective working relationships with a range of individuals in different roles and from a variety of departments, institutions and organizations. Ability to lead a group, serve as a mentor and/or facilitator, and create a positive work environment.
• Strong critical thinking and problem-solving skills with a solution-oriented approach to issues
• Strong multi-tasking capabilities
• Detail oriented while still seeing the "big picture"
• Demonstrated ability to manage QC plan and execute projects, organize and track data/metrics.
• Demonstrated ability to provide leadership and flexibility through a consultative role in a changing/evolving work environment.
• Demonstrated excellent customer service skills; ability to ensure and deliver a customer service orientation that translates into timely and reliable guidance / service to investigators and staff.
• Energy and drive to coordinate multiple projects simultaneously.
• Ability to use tact and diplomacy to maintain effective working relationships.

Physical Demands & Equipment Usage:

• Ability to sit, stand, reach, lift, bend and stoop
• Frequent sitting, standing, reaching, typing, and lifting up to 3 lbs.  Occasionally lifting up to 20 lbs.
• Heavy use of computers, web conferencing and long periods of sitting
• Ability to compose and prepare materials, memoranda and reports
• Regularly required to talk, hear, and/or communicate with others by phone, in person and through electronic means
• Ability to handle a fast-paced work environment with multiple time sensitive competing demands
• Requires ability to respond quickly and appropriately to urgent situations that may arise

Preferred Qualifications

• Degree in physical science and/or nursing
• Oncology-specific experience
• Investigator-initiated trial-specific experience
• Medical terminology
• ACRP or SOCRA certification
• RN license

Additional Details

Apply online via OHSU Careers site. Please be sure to upload a Cover Letter and Resume/CV.

Why apply to OHSU?We are Oregon's only public academic health center. In addition to caring for patients, we lead groundbreaking research. We also train the next generation of health care professionals. As Portland's largest employer, we give you opportunities to learn and advance in a system of hospitals and clinics across Oregon and Southwest Washington. All are welcome. OHSU welcomes people of all ages, ethnicities, genders, national origins, religions and sexual orientations. We are striving to build an anti-racist, multicultural institution and encourage people with diverse backgrounds to apply. To request reasonable accommodation, contact askhr@ohsu.eduEmployment Type: FULL_TIME