Clinical Research Monitor (Research Project Manager)

Oregon Health & Science University•Portland, OR

17h•Hybrid

About The Position

The OHSU Knight Cancer Institute is a leader in personalized cancer medicine and research. The Knight Cancer Clinical Research (KCCR) organization supports translational clinical research to improve the lives of people with cancer through innovative strategies for prevention, screening, diagnosis, and treatment. This is achieved through proactive, high-quality, and efficient study management that complies with federal regulations and institutional policies. The Clinical Research Monitoring Program is part of KCCR and supports investigators conducting cancer-related research under an IND or IDE. The Clinical Research Monitor is responsible for ensuring research integrity and compliance with protocols, institutional policies, state and federal regulations, and Good Clinical Practice (GCP) guidelines by developing and maintaining Trial-Specific Monitoring Plans (TSMPs) and evaluating clinical trial conduct. The role involves identifying and proposing revisions to educational materials, toolkits, and SOPs to ensure consistent messaging regarding processes, regulatory compliance, and research integrity. The individual manages their workload independently within the KCCR/Monitoring Program service level, understanding timelines and job expectations.

Requirements

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.
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.
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.

Nice To Haves

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

Responsibilities

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, regulatory requirements, institutional policies, and NCI policies relating to human subject research according to the approved TSMP.
Prepares for and schedules monitoring visits, communicates with relevant parties, reviews regulatory documentation, subject source documentation, and investigational product accountability records.
Uses critical thinking and clinical judgment to assess findings and serves as a resource to the sponsor and team.
Compiles clear and concise monitoring reports 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.
Develops and maintains a detailed tracking mechanism (e.g., spreadsheet or database) to document all aspects of monitoring program data, including monitoring dates, activities, findings, action items, and due dates.
Develops processes, policies, materials, and documentation for this position and continuously updates as appropriate.
Collaborates on the development of both internal and external guidance documents, policies, and practices to improve compliance by sponsors, 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).
Collaborates and contributes to the success of the Knight Cancer Clinical Research Strategic Plan, as appropriate.
Participates in and contributes to team meetings and huddles, Knight-wide meetings, inter-departmental collaborations, process improvement initiatives, mentorship, and professional development activities.
Remains current on OHSU-wide updates and fulfills all OHSU requirements necessary for ongoing employment.
May provide back-up support to other KCCR positions/activities as needed for coverage purposes.