UNIV - Research Nurse Manager (Hollings)

Apply now Job no: 504297
Entity: MUSC University
Department: ACADEMIC AFFAIRS - Hollings Cancer Center
Sub Department: UNIV-2101020-HCC Clinical Trials Office
Work type: Full-Time
Employee Type: UNIV - Classified
Location: Charleston, SC
Categories: Nursing Management
Pay scale: UNIV-Band 7: $48,622.00 - $69,289.00 - $89,956.00 (min - mid - max)

Job Duties:
25Quality Assurance and Education. Provide mentorship and education for study coordinators who help oversee study patient participation and help ensure protocol compliance. As part of the CTO quality assurance team, this position will conduct the patient eligibility reviews required prior to patient registration to the study to ensure that all source documents are present per protocol and federal regulations. Will utilize the patient eligibility reviews as a means for additional one-on-one training with the study coordinator and clinical staff or development of specific educational programs and trainings to support greater clinical trial education and compliance. Will provide general medical terminology training to study coordinators and data managers and serves as a day-to-day clinical resource to the clinical operations study coordinators and data managers for assistance with understanding and interpreting clinical documents, language, and patient process. Will develop education materials and conduct new employee and advanced employee clinical operations trainings. Will assist with conducting patient case reviews as part of the CTO internal quarterly audits and help review and respond to audit reports.Essential
35Protocol Implementation and Support: Participates within the HCC CTO Research Allocation and Feasibility Team (RAFT) to read protocol 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 disease focus group (DFG) 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 managers, EPIC and Beacon build managers to ensure that study treatment plans are built in accordance to the protocol for newly activated and amended therapeutic protocols. Will review study specific roadmaps to ensure that roadmaps are developed per the protocol and operational assessment determined by the DFG. Will participate in the Beacon build validations. Will review protocol amendments and make changes to the roadmap as needed and per standard operating procedures. Utilizes CTO systems such as SharePoint and RAPID 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 unit to correct roadmaps and update treatment plans and re-educate study coordinator and investigators as neededEssential
35Protocol 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 for protocol compliance. Works closely 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 Guidelines. When studies are activated and patients are enrolled, works with the study coordinator and care team to ensure tests and/or procedures are completed as required, results are reviewed, correctly interpreted and communicated with regard to protocol guidelines and appropriate interventions occur based on test results. In collaboration with the clinical operations manager, conducts weekly meetings with the study coordinators to ensure patients are appropriately linked to validated treatment plans. Will help study coordinators with general patient screening and protocol treatment questions. Will help study coordinator with questions related to grading toxicities and communicating dose modifications requirements to study coordinator and investigators.Essential
5Special Projects and Additional Duties. Provide project management of special activities.Essential


Job summary: 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 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. When complex trials are identified that require additional nursing resources, this individual will be assigned to the study and provide study specific nursing services such as observation, neurocognitive assessments, etc. Additionally, the nurse manager will collaborate closely with other clinical operation managers, EPIC and Beacon build managers to ensure that study treatment plans are built in accordance to the protocol for newly activated and amended therapeutic protocols. This position will be part of the CTO quality assurance and education unit and will report to the HCC CTO Director. 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. Must work collaboratively with CTO managers and ancillary services in program development and strategic planning. Responsible for the establishment of clinical operation standard operating procedures and proper training and quality assurance initiatives. 

 


Payscale Salary Range: UNIV-Band 7: $48,622.00 - $69,289.00 - $89,956.00 (min - mid - max)


FLSA: Salaried


Minimum Experience and Training Requirements: Graduation from an accredited school of nursing and five years related nursing experience. A bachelor's degree in nursing may be substituted for two years of the required work experience. Licensure as a Registered Nurse by the South Carolina Board of Nursing. Some positions require certification as a generalist in a related specialty area by the American Nurses Association (ANA). Requires certification in Basic Life Support.


Physical Requirements: Ability to perform job functions in an upright position. (Continuous) Ability to perform job functions in a seated position. (Infrequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to climb stairs. (Infrequent) Ability to climb ladders. (Infrequent) Ability to work indoors. (Continuous) Ability to work from elevated areas. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to bend at the waist. (Frequent) Ability to twist at the waist. (Frequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Continuous) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to fully use both legs. (Continuous) Ability to reach in all directions. (Continuous) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to maintain good olfactory sensory function. (Continuous) Ability to lift and carry 50 lbs., unassisted. (Frequent) Ability to lift objects, up to 50 lbs., from floor level to height of 36 inches, unassisted. (Frequent) Ability to lower objects, up to 50 lbs., from height of 36 inches to floor level, unassisted. (Frequent) Ability to lift and carry patients weighing up to 350 lbs., assisted. (Frequent) Ability to push/pull objects, up to 350 lbs., unassisted. (Frequent) Ability to maintain 20/40 vision, corrected. (Continuous) Ability to see and recognize objects close at hand. (Continuous) Ability to see and recognize objects at a distance. (Continuous) Ability to match or discriminate between colors. (Continuous) Ability to determine distance/relationship between objects; depth perception. (Continuous) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to hear and understand whispered conversations at a distance of 3 feet. Must be ambidextrous. Ability to perform gross motor functions with frequent fine motor movements. (Continuous) Ability to be qualified physically (by medical personnel) for respirator use, initially and annually


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Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.