Research Nurse Manager at Hollings Cancer Center

Job Description

The Hollings Cancer Center (HCC) Nurse Manager II is responsible for the provision of nursing education and mentorship to the non-nursing staff HCC Clinical Trials Office (CTO) and serves as a liaison to other clinical services and providers within HCC outpatient and inpatient clinics, the HCC infusion center, and other ancillary departments.

The Hollings Cancer Center (HCC) Nurse Manager II is responsible for the provision of nursing education and mentorship to the non-nursing staff HCC Clinical Trials Office (CTO) and serves as a liaison to other clinical services and providers within HCC outpatient and inpatient clinics, the HCC infusion center, and other ancillary departments. This position will be part of the CTO Clinical Operations Unit and will report to the Deputy Director of the Clinical Trials Office.

This individual must work collaboratively with CTO managers and ancillary services in program development and strategic planning- which includes participating in the organization and management of the new 3rd Floor HCC Research Infusion Suite and expansion of research services to satellite sites. This individual will participate in the feasibility review process by reviewing protocols and determining the study patient flow and provision of center resources to promote protocol compliance and study participant retention.

Additionally, this nurse manager II will collaborate closely with other clinical operation program managers and the EPIC/Beacon build team members to ensure that study treatment plans are built in accordance with the protocol for newly activated and amended therapeutic protocols. The Nurse Manager II will have a key role in helping train and mentor new study coordinators and data managers in understanding oncology terminology and concepts.

This individual must be knowledgeable of Food and Drug Administration federal regulations, local regulatory agency policies, and international Good Clinical Practice Guidelines to ensure that the conduct of clinical research activities remain in good standing and research performance excels in quality and efficiency. Responsible for the establishment of clinical operation standard operating procedures and proper training and quality assurance initiatives.

Nursing experience in Oncology or Hematology is strongly preferred.

(35%) Protocol Implementation and Support:
Participates within the HCC CTO Research Allocation and Feasibility Team (RAFT) to read protocols and develop the best method for protocol implementation. Responsible for facilitating the interaction between HCC’s clinical research program and the clinical service line components. When complex trials are identified by the RAFT and the HCC clinical research groups (CRG) that require additional nursing resources greater that what is provided as standard of care, this individual may be assigned to the study and provide study specific nursing services such as ECOG performance status assessments, vitals, EKGs, etc.

Additionally, the nurse manager will collaborate closely with other clinical operation program managers. They will participate as a member of the CTO EPIC/Beacon build team and ensure that study treatment plans are built in accordance with the protocol for newly activated and amended therapeutic protocols. This individual will review study specific roadmaps to ensure that roadmaps are developed per the protocol and operational assessment determined by the CRG.

Will lead the Beacon build validation meetings. Will review protocol amendments and make changes to the roadmap as needed and per standard operating procedures. Utilizes CTO systems such as SharePoint and OnCore to mark milestone updates. As new protocol amendments are released, re-evaluates the protocol for feasibility and works with the clinical operations group to make adjustment to study operations, allocation of resources and modification of study source documents as needed.

If protocol deviations are identified due to Treatment Plan deficiencies, works with the CTO EPIC Beacon team to correct roadmaps, and update treatment plans and re-educate study coordinator and investigators as needed.

(35%) Protocol Specific Clinical Operations Support:
Reviews new protocols and new amendments with the study coordinators to ensure proper understanding of the investigational interventions and protocol requirements. Assists with protocol-specific training of all clinic, ancillary and program staff. May develop and conduct educational in-services to interdisciplinary care teams to foster protocol compliance. May work with the HCC nurse navigators to market trials and assist them and the study coordinators in the best method and timeframe to identify potential study patients.

Helps develop eligibility criteria source document tools and other study specific source documents to improve protocol compliance and adherence to the FDA Code of Federal regulations and Good Clinical Practice…