Clinical Research Monitor; Research Project Manager

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.

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.
  
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