Research Project Coordinator, Entry

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.

 

Cancer Early Detection Advanced Research Center (CEDAR) is a highly collaborative institution within the OHSU Knight Cancer Institute. At CEDAR our mission is to detect and stop lethal cancers at the earliest stage because early detection saves lives. This is an ambitious goal, one that requires novelty, creativity, and innovation. We conduct groundbreaking translational cancer research to help people maintain a high quality of life and reduce cancer mortality, to create a global early detection community, and to have a positive impact on the Oregon economy. Our clinical trials are cutting edge and laser focus on the exciting and rapidly evolving area of cancer early detection

 

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

Function/Duties of Position

The Clinical Research Project Coordinator oversees and manages the day-to-day operations of clinical research activities for studies conducted at CEDAR. The Project Coordinator must understand how clinical and research operations work within the clinics/hospitals their team works in and the departments they collaborate with. They must have the ability to cover all roles that are part of the project and be the main point of contact for the study team members regarding operational aspects of clinical research, resolve issues and remove obstacles for study team members, assist in managing priorities, and identifies opportunities for process improvement.  The Project Coordinator will also manage coverage issues related to sick calls and vacation time and may fill in to assist with responsibilities following a position vacancy.   The Project Coordinator may  mentor junior coordinators

 

In addition to leadership responsibilities, this individual maintains direct clinical research study management duties. Study management responsibilities include coordinating all aspects of a study as specifically outlined in the protocol and compliance with applicable regulations, including Good Clinical Practice. The candidate will work collaboratively with the investigator, study sponsors, clinical trials team, and other OHSU departments in the execution and management of subject research activities. The candidate will maintain accurate, complete, and timely records on research subjects that may include the preparation of source documentation and clinical research data/case report forms.   The candidate can represent the investigator during monitor visits and on-site audits conducted by the sponsor or sponsor representative. The candidate may assist the Regulatory coordinator(s) with the IRB submission, to include preparation of consent forms and other documents required for IRB review.

 

Key Responsibilities:

• Study Lead Responsibilities
  • Act as a resource for study coordination team members
  • Act as a go between with the trial manager to synthesize the state and needs of the team
  • Meet with team members on a regular basis to monitor and assess workload, establish study priorities, and help escalate identified issues to the manager as needed
  • Facilitate and actively participate in new personnel training in collaboration with the Clinical Trials Manager and other staff members
  • Identify need for retraining of personnel as issues are identified and ptovide training on study procedures
  • Participate in clinical trials plan and act as lead on projects.
  • Keeps Clinical Trials Manager appraised of overall project performance (i.e., staffing or resource needs, completion dates, changes/delays in scheduling, etc.) and study portfolio management
  • Identify study process improvement opportunities, assess needs, implement solutions and evaluate effectiveness, in collaboration with Clinical Research Manager
  • Develop study transition plans for on-boarding new staff or off-boarding of staff leaving their positions, in collaboration with the Clinical Trials Manager
  • Provide general input and recommendations on personnel performance, workload, and team resource needs (i.e., supplies, OHSU system access requests, equipment, etc) to Clinical Trials