Clinical Research Nurse Manager - Endocrinology

Position Summary:

This is a key leadership position in the Clinical Trials Office (CTO). The Clinical Research Nurse Manager will provide consistent leadership and oversight of the endocrine clinical research staff within the CTO; ensure competent and standardized staff practices, and coordinate strategies to enhance interdepartmental communication and collaboration among disease team physicians, inpatient staff and the Clinical Research Unit (CRU) staff.

Provides leadership to faculty (medical, surgical and basic science), is responsible for the development, implementation and coordination of the endocrine disease team and team's interventional clinical trials. Clearly delineates roles, responsibilities and accountabilities for protocol initiation. Assists in determining operational factors and acuity scores which support clinical research protocols that move forward. Responsible for initiating training programs and ensuring that endocrine clinical research nurses and staff are educated in current clinical research guidelines.

The Clinical Research Nurse Manger shall be the point person to ensure that the process flows for the EPIC and Oncore Beacon protocols represents best practice and can ensure work standardization and compliance. Integral to this job is the need to ensure that CRCs and CRNs partner effectively on each protocol and that In-service training is conducted expeditiously.

Collaborates with CTO leadership and staff to develop and participate in presentations to internal and external groups on study activation including the status of protocols, validation of the EPIC Beacon builds and other topics as needed. The Clinical Research Nurse Manager supports high quality research, customer service excellence and fiscal responsibility while serving as a direct link between the clinical research staff, research operations leadership and physician and scientific leadership.

Key Responsibilities include:

Planning and Goal Setting

•Work in conjunction with the endocrine disease team leaders, physician and scientific faculty, Cancer Center and research operations leadership to accomplish goals, projects and research initiatives for assigned disease teams.

•Build and sustain relationships with internal and external stakeholders.

•Manage and implement departmental programs and goals that support the strategic plan for the organization and for clinical research across COH.

•Support departmental implementation of new technology, including EPIC and Oncore adoptions.

•Prepare reports, presentations, action plans, and other deliverables.

•Review reports submitted by staff members to recommend approval or suggest changes.

•Effectively communicate (written & oral) across the organization.

Patient Care and Quality Research

•The person in this position will be one of the CTO primary points of contact within City of Hope's clinical research infrastructure.

•Must be able to develop and sustain positive and effective working interdisciplinary relationships across COH, including physicians, Nurse Practitioners/Mid-Level Providers (NPs/MLPs), clinical nurse managers and staff, and other research personnel (e.g., statisticians, Protocol Development Coordinators, etc.).

•Establish standards for clinical research activities to assure patient safety, protocol compliance and timely and accurate data collection.

•Provide leadership to faculty (medical, surgical and basic science) on initiating and implementing protocols for clinical trials. Clearly delineates roles, responsibilities and accountabilities for protocol initiation. Responsible for identifying operational issues to move clinical research protocols forward.

•Identify and develop processes and standard operating procedures to support quality research.

•Ensure that CTO processes and procedures for identifying potential non-compliance or unanticipated problems are consistent with IRB policies and procedures.

•Escalate any concerns regarding compliance to appropriate authorities and conduct investigations as required.

•Assure satisfaction of research subjects, investigators, physicians, disease team lead physicians and scientists, external sponsors and other customers with the conduct of clinical research.

•Develop and foster collaborative relationships with other departments to support safe and high quality patient care and services.

•Assure regulatory standards are met.

•Initiate and support quality improvement processes within the department.

•Measure performance of staff to meet research protocol, regulatory and patient care standards.

•Monitor and report results of ongoing quality metrics as appropriate.

•Support & facilitate critical thinking of staff.

•Participate in or leads committees and working groups within the institution as required or applicable.

Personnel Management

•Recruit and maintain an adequate number of competent staff to conduct clinical research in compliance with all regulatory, institutional, and departmental requirements. Assist in providing staffing projections based upon metrics and study volume including presentation to appropriate stakeholders.

•Assign or delegate responsibilities to direct reports.

•Develop, maintain and monitor staffing plan for assigned disease teams.

•Direct or coordinate efforts to increase efficiency.

•Responsible for the orientation and ongoing training and development of staff.

•Develop and implement ongoing training programs for staff.

•Responsible for the performance management of CTO endocrine staff including, Clinical Research Nurses and Clinical Research Coordinators.

•Complete annual evaluations as required by human resources and the CNA.

•Participate in the interview and selection process for research personnel.

•Monitor time and effort tracking reports on a periodic basis.

•Collaborate with human resources to provide counseling and/or implementation of performance improvement plans for staff as needed.

•Responsible for tracking the current status of all required licenses, certifications and any required competencies.

•Manage and lead staff to develop collaborative working relationships within the department and with other departments as applicable.

Fiscal and Budget

•Assist the Solid Tumor Nurse Director in the development of the annual budget and review the P/L of the endocrine disease team.

•Monitor financial reports and variances from budget on a periodic basis.

•Review staffing plans for each of the endocrine disease team and work with leadership to ensure appropriate support based on protocol acuity.

•Identify need for modifications to endocrine disease team staffing plan and submit justification for new positions or changes to staffing plan.

•Identify and communicate opportunities for improved efficiency and/or cost saving within the department.

•Monitor expenses and support cost saving programs across research operations.

•Collaborate with Clinical Research Operations Leadership in the development of new programs or services.

•Participate in operational and feasibility assessments performed within the disease programs.

Basic education, experience and skills required for consideration:

• Bachelor of Science in Nursing
• Five years of nursing experience with at least 2 years or more years of related experience in oncology or diabetes research. Experience with immunotherapy, including biologicals and cell therapy preferred but not required.
• Strong verbal and written communication skills.
• Thorough knowledge of Good Clinical Practice, Human Subject Protection, clinical trial design, regulatory processes, and clinical development process.
• Ability to collaborate with internal and external stakeholders across functions to optimize performance and drive projects to completion.
• Excellent interpersonal, leadership, decision-making and issue resolution skills.

Required Certification/Licensure:

Current California RN license (If out of state, must obtain CA RN license within 90 days of start date)

Preferred education experience and skills:

• Master of Science in Nursing
• Previous management experience preferred.

Preferred Certification/Licensure:

• Oncology Nurse Certification (OCN, AOCN, AOCNS, or AOCNP) and certification by the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

Additional Information:

• Shift: Days
• Job Status: Full-time

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.

LI - KH #Nursing

• Posting Date: May 17, 2021
• Job Field: Clinical Research
• Employee Status: Regular
• Shift: Day Job