NCTN Program Coordinator

NCTN Program Coordinator-38217University Staff

Description

University of Colorado Anschutz Medical Campus

Department :  Cancer Center

Working Title :  NCTN Program Coordinator

Position # : 00703383 – Requisition # : 38217

Job Summary :

The National Clinical Trial Network (NCTN) Coordinator will serve as a member of the NCTN program housed within the Oncology Clinical Research Support Team (OCRST).This position will support the needs of the NCTN and Lead Academic Participating Site (LAPS) Program at the CU Cancer Center and at affiliated performance sites located throughout Colorado. In collaboration with the NCTN Program Manager,thispositionwillcoordinate activities related to new site performance site set up, and act as a resource to affiliate sites to ensure all aspects of trials being conducted at sites follow regulatory as well as clinicalcompliance. In addition, this position will be responsible for compiling and reportingstudyandaccrualmetrics in order tomeetgrant requirements, coordinate onboarding activities for investigators and staff involved in the conduct of NCTN trials, ensure sites and investigators remain in good standing for continued participation in NCI sponsored clinical research studies,and coordinate agenda and gather necessary data for the LAPS Executive Committee meeting and other program meetings.

Key Responsibilities :

Assist in coordination of activities of the LAPS Executive Committee including compiling protocol and site-specific information on new study activations to be reviewed, gather accrual data to be presented, and distribute agenda and meeting materials including minutes to attendees.

Coordinate necessary activities for new performance site set up in accordance with NCTN / NCI Cancer Therapy Evaluation Program (CTEP) requirements. Activities may include obtaining CTEP institution codes and Radiation Therapy Facility (RTF) numbers, managing appropriate LAPS site roster, and ensuring all standards for new sites are met and relayed to the appropriate parties.

Manage activities related to performance site pharmacies including appropriate set up with PMB (Pharmaceutical Medical Branch of the NCI), submission of pharmacy worksheets to CTEP and ensuring that the pharmacy worksheet accurately reflects pharmacy staff at each site.

Manage Clinical Trial Support Unit (CTSU) database and roster new staff and investigators as they are onboarded to performance sites.

Act as Administrator of the NCI Registration and Credentialing Repository (RCR) database of Investigators, Co-Investigators and research pharmacists. This includes creating and submitting NCI profiles for the above as well as updating renewals on an annual basis.

Nominates new investigators to national groups as needed.

Nominates new investigators to national groups as needed.

Ensures that the NCTN website remains up to date with relevant changes and updated education materials.

Participate in planning, conduct and follow up activities related to the Annual NCTN Educational Retreat. Records annual retreat or other educational sessions and adds them to the NCTN website for further distribution, education and training.

Assist with the annual LAPS reporting needs, accrual data, new protocol activation data, and progress in regards to the program growth and development; , including but not limited to new site activation, manuscript submissions, and investigator leadership and engagement.

Monitors monthly Institutional Progress Reports to ensure UCCC remains in good standing with the National groups by coordinating the distribution of the Institutional Progress Reportstoclinicalresearchstaffandfollowingupondelinquentdata(>

90day past due).

Submit monthly clinical trial pipeline reports for the project management teams to monitor activity on new clinical trials.

Assist with collection of materials needed for audits (DSMC, National groups)

Develop, implement, and maintain tracking and reporting tools to meet program goals, improve transparency of processes.

Participate with the Oncology Clinical Research Support Team (OCRST) and other Cancer Center departments to identify and implement ways to improve procedures and workflows.

Willingly accepts additional responsibilities and duties as assigned by management

Program Coordinator Level II Duties (Senior)

Adheres to and conducts all duties related to Program Coordinator Level I

Independently manages and provides support to more complex tasks and assignments

Travel to LAPS participating sites to assist with training, conduct compliance monitoring, provide general assistance, and guide audit preparation as needed.

Coordinate and manage activities related to new investigator and staff onboarding, credentialing, and rostering in accordance with UCCC and NCI requirements

Recommends and drafts enhancements to SOP’s, guidance documents or other tools / templates pertinent to NCTN / LAPS Program

Work Location :

Hybrid – this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.

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