Job Description: Oregon Health & Science University
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.
Cancer Trial Network (CTN) Project Coordinator
US-OR-Portland
Job ID: 2024-31969 Type: Regular Full-Time # of Openings: 1 Category: Research Portland, OR (Waterfront)
Overview
This Research Project Coordinator (Cancer Trial Network (CTN) Project Coordinator) is responsible for the completing, facilitating, managing, and/or overseeing activities related to research operations of Cancer Trial Network (CTN) studies, including trial coordination, regulatory, quality assurance, membership, data activities, and more. The NCTN Project Manager works with Knight Cancer Institute clinical research teams responsible for the initiation, planning, coordination, and execution of clinical trial projects. This role involves establishing and updating formal processes that support all CTN clinical research. The CTN Project Manager functions as a liaison for NCI, NCTN, ETCTN, OHSU, KCI, investigators, and staff. The role will guide the initiation, planning, coordination, and execution of clinical trial projects and ensure adherence to regulatory policies, procedures, practices, and laws. The CTN Project Manager will be accountable for representing KCI and will promote CTN roles, responsibilities, and standards while embodying the guiding principles within all interactions.
Key Responsiblities:
CTN Project Coordination
Act as liaison between NCI CIRB, OHSU IRB, and disease teams to ensure all stakeholder needs and requirements are met.
Deliver updates, training, and information during regular CTN meetings with participating PIs and staff.
Review, track, process, and disseminate all pertinent information received via CTN alerts, broadcasts, announcements, and newsletters, and/or delegate as appropriate.
Assist with the coordination, completion, and tracking of activities for CTN studies to ensure compliance with NCTN, ETCTN, federal, and local rules/regulations.
Prepare, distribute, and/or lead study training for assigned CTN protocols; track attendance and completion by all delegated research individuals.
Communicate and distribute IRB approvals and updates to research teams promptly, per policies.
Create, update, and share tracker(s) to provide updates and offer transparency regarding regulatory and protocol compliance.
Review, prepare, educate, guide, and facilitate LPO audits for all CTN-supported teams.
Help develop and maintain user-friendly tracking mechanisms that document all aspects of monitoring and compliance
Ensure all regulatory and patient records are audit-ready per FDA, NCTN, ETCTN, and local rules/regulations.
Communicate, escalate, and/or delegate all tasks as needed; provide support and training as needed to ensure task completion.
Coordinate and aid in the development and maintenance of CTN training materials and resources to encompass CTN/KCI policies and procedures, meet CTN training requirements, and provide necessary CTN updates.
llaborate with Clinical Research Quality & Administration (CRQA) trainers to ensure the incorporation of new CTN requirements into the KCI education program/materials.
Evaluate logistics and processes continuously to identify and participate in process improvement projects within the CTN program to ensure CTN responsibilities are effective and efficient.
Assist with tracking requirements, develop tracking reports, and prepare documents to submit the LAPS grant application successfully.
Provide support to KCI staff and within meetings to support the CTN program, projects, tasks, and staff.
Assist with the creation, distribution, resolution, and escalation of CTN data reports, queries, delinquencies, specimens, and compliance.
External CTN Involvement
May participate as an acting member on external CTN committees, as assigned and as time allows, such as NCTN/ETCTN LPO bi-annual meetings.
As applicable, review new clinical research protocols for site-specific implications and make change recommendations to encourage and ease site participation.
Represent OHSU KCI, the CTN Program, and CTN ideals when providing clinical research and public relations support.
Membership and Rostering
Aid with the creation and management of CTEP, RCR, and CTN memberships for all OHSU staff and research programs (disease teams); delegate as appropriate.
Communicate membership status to Research Pharmacy Services (RPS) to ensure only NCI-designated physicians participate in the Investigational Product (IP) ordering process.
Assist in maintaining institutional, CTN membership rosters and ensure adherence to NCI/NCTN/ETCTN policies and procedures.
Coordination of Network Sites
Assist CTN Project Managers with facilitation of CTN research at affiliate sites. May include assisting with:
affiliate roster needs
education to promote affiliate and network site understanding, as applicable
affiliate audit needs, as applicable
facilitation of trials at affiliate sites and participate in routine protocol teleconferences to discuss regulatory oversight and updates
creation, distribution, and routine maintenance of Clinical Research Handbook for affiliate sites
meetings with sites as needed
timely distribution of protocol updates to sites as needed, including but not limited to protocol amendments, safety reports, and investigator brochures
maintaining audit-ready files for sites
maintenance of CTN training materials and resources and provide necessary updates for sites
Responsibilities
Education & experience:
Master's in relevant field AND 1 year of relevant experience OR Equivalent combination of training and experience.
At least 3 years of clinical research specific experience
Knowledge, skills, and abilities:
Proficiency with MS Office Suite, Visio, and MS Project
Strong program management skills
Proven ability to collaborate with scientific and/or medical staff
Excellent oral and written communication skills
Excellent documentation and organizational skills; detail-oriented
Qualifications
Master’s degree or Clinical Research Certificate
Experience in oncology clinical research is strongly preferred
