Under the supervision of the Administrative Director of Clinical Operations for the Perlmutter Cancer Center (PCC) Clinical Trials Office (CTO), the Assistant Director for the Clinical Coordination Unit provides leadership and oversight of the daily activities of the CTO Clinical Coordination Unit (CCU) across PCC campuses ensuring compliance with institutional and research related requirements. The CCU is currently comprised of ten managers who support 65 staff across four cancer center campuses in Manhattan, one in LI and one in Brooklyn.
Assists the Administrative Director in the oversight of all PCC CTO clinical sites including supporting network expansion, clinical trial operationalization, complex trial management (solid tumor cellular therapy, inpatient trials, early phase trials) and ensuring safety and quality metrics are met. Collaborates with the AD RBMU to support clinical trials at current and new network campuses under the supervision of the Administrative Director, Clinical Operations.
Develops and maintains standard operating procedures (SOPs) for all processes and workflows supported by the CCU. Serves as a liaison between other ADs in the CTO and other managers in PCC departments. Oversees the onboarding and training of CCU staff, mentorship and development of staff and clinical managers, innovation and improvement of operations and monitors safety data related to RNIs/deviations/violations to ensure targeted training/education and ongoing excellence of research clinical care.
The AD is responsible for quarterly reporting to the Administrative Directors and CTO leadership related to clinical operations and growth, clinical staffing and retention, auditing and compliance and supporting the preparation for the Cancer Center Support Grant as it relates to the CCU.
The AD conveys a positive and professional image while representing the clinical trials office in a professional, courteous, and efficient manner.
Relocation bonus available upon department discretion.
1. Demonstrates clinical knowledge and skills in the areas of management and leadership and directs managers and their staff in its application.
2. Maintains a 10% clinical research practice in a DMG and precepts, mentors and trains managers and staff in clinical research competencies.
3. Oversees and plans for the staffing needs of the network campuses sites on a short- and long-term basis, adjusting based on workload and other staffing variables to maintain safe, efficient care in an effective manner. Oversees safe staffing and scheduling for the unit, monitors appropriate use of benefit time, and approves and tracks overtime for clinical research nurses including annual budgeting related to OT. Trains clinical managers on how to schedule staff for optimal availability of resources and cross-coverage. Evaluates the acuity of each DMG/site on a monthly basis and reports staffing needs and proposed solutions to the Administrative Director of Clinical Operations. Provides leadership for coordination of daily clinical research activity.
4. Interviews and recommends hiring of applicants for clinical research positions with the Clinical Managers and the HR Talent Acquisition Dept.
5. Counsels and coaches managers concerning their work performance and development and provides support to managers on how to counsel and coach staff; holds managers and staff accountable for safe, quality performance. Establishes work performance and clinical competency of personnel on a timely basis and approves ladder promotions and in-unit transfers prior to CTO leadership approval. Investigates incidents and occurrences and institutes corrective action as appropriate in collaboration with Human Resources.
6. Establishes a pleasant working environment conducive to teamwork, growth and recognition. Participates in leading HRO meetings and supporting the HRO leadership team. Assimilates NYU PCC and CTO core values of compassion, dignity, inclusivity, respect throughout all processes and interactions.
7. Maintains effective, ongoing and timely communication with managers and staff and maintains records of meetings. Oversees that managers maintain records on licensure, certifications and competencies of the staff. Oversees the regular staff meetings with CCU staff ensuring they receive important communications and are continuously trained on any new processes or procedures applicable to their roles. Functions as a respected member of the research team. Ensures pertinent communication with clinical research staff issues.
8. Provides clinical leadership by assessing, implementing, & evaluating the care provided to patients and families by CCU staff. Establishes a mechanism for patient feedback related to their trial experience.
9. Acts as a professional role model to all levels of research staff by incorporating expertise, critical thinking, and related experience in all research aspects in the care of patients and caregivers. Participates in the clinical and leadership development of employees in the CCU. Supports mentorship of managers and staff to maintain and improve staff retention and the internal promotion rate.
10. Establishes/maintains processes to promote a multidisciplinary team approach in developing, implementing and evaluating patient care and/or caregiver education in the context of clinical research.
11. Serves as a leadership liaison to all other departments in the PCC and NYU system and demonstrates effective teambuilding and problem solving strategies in interactions. Collaborates with managers and staff at all PCC CTO campuses to support growth and consistent operational standards.
12. Maintains awareness of research protocols, ensures knowledge of staff, protects patient rights, and participates in assessment & evaluation of outcomes. Participates in protocol feasibility process, to ensure availability of resources in order to fully execute clinical trials safely and efficiently. Participates in the identification and planning for future resource allocation for CTO network sites.
13. Collaborates with the Administrative Directors for appropriate supplies and equipment and ensures proper utilization, maintenance and accountability for supplies and equipment on unit(s). Provides input related to CTO fiscal year budgeting needs for operational planning and growth.
Education, Training and Compliance:
14. Responsible for the onboarding, training, and ongoing supervision and development of Clinical Research Nurses and Clinical Research Coordinators assisting Principal Investigators in the conduct of oncology therapeutic and non therapeutic clinical research and clinical managers. Responsible for the management of a comprehensive onboarding, orientation and ongoing training program for the CTO CCU to promote the retention of staff and collaboration with PCC and CTO leadership in identifying, addressing, & utilizing available resources to meet the learning needs of the research staff. Provides coaching and retraining as necessary and may interact with the Employee Relations department when necessary.
15. Creates and maintains standard operating procedures under supervision of CTO and PCC leadership. Participates and/or leads SOP creation and revision projects. Ensures CCU staff are trained on and adherent to current approved institutional and departmental SOP’s.
16. Guides, develops, and counsels staff regarding practice and performance standards. Participates in the implementation of staff improvement plans. Provides input to and participates in informal and formal review of performance standards of clinical research staff.
17. Ensures high quality source documentation according to ICH-GCP and federal guidelines and provides recommendations for corrective action when necessary.
18. Conducts root cause analysis when necessary to identify, correct and prevent protocol related deviations and ensure safe patient care. Collaborates with the Administrative and Medical Directors of the CTO and CTO managerial colleagues to manage and document performance and quality improvement projects and supporting departmental implementation of new technology impacting the clinical operations of the CTO.
19. Participates in study audits, in conjunction with industry or regulatory representatives, and supports internal training and education related to internal and external audit findings to improve processes, policies and workflows.
20. Demonstrates effective written and oral professional communication across the organization. Communicates and escalates unresolved issues at the appropriate time to the appropriate level of management/leadership.
21. Fosters an environment that promotes patient, family, provider, and staff satisfaction.
22. Utilizes effective conflict resolution strategies when dealing with staff, providers, investigators, patients and caregivers.
23. Manages and leads staff to develop collaborative working relationships within the cancer center and with other NYU departments as applicable. Acts as a liaison with the EPIC/MCIT team, Investigational Pharmacy, Disease Management Group faculty leaders, laboratories, and other units of the Clinical Trials Office in an effort to maintain efficient operations of the CCU and CTO.
24. Assists in facilitating a collaborative interdisciplinary approach to achieve optimal research related outcomes. Supports the mission, philosophy, standards, goals, and objectives of NYU, Ambulatory Care Center, Perlmutter Cancer Center, and the CTO.
25. Collaborates with CTO managers and directors to ensure effective and efficient intra-departmental team collaboration and communication and acts as a role model to all CTO staff by consistently demonstrating positive and professional collaboration within the CTO, PCC and NYU.
26. Serves as a role model to staff in considering needs and behaviors of specific patient & cultural groups. Demonstrates an awareness of and respect for coworker’s and patient’s cultural background. Supports and models the principles of a high-reliability organization.
27. Conducts performance management monitoring and participates in problem identification and solution finding to improve key processes/systems/patient care. Shares results in staff meetings and encourages staff participation in performance management and quality improvement initiatives. Participates on a voluntary or appointed basis in inter and intra-departmental and inter-disciplinary committees to improve patient care.
28. Considers a wide range of factors when making decisions; develops business plans to meet customer needs; adjusts actions and decisions for focus on critical strategic issues.
29. Gathers relevant information systematically to generate solutions. Adept at using statistical/financial information to problem solve and grasps complexities and perceives relationships between issues.
30. Demonstrates flexibility to shifting priorities and rapid change. Understands broad organizational and business issues, has and uses cross functional knowledge, and knows how to get things done and whom to involve at the appropriate time.
31. Provides cross coverage for clinical management colleagues within the CCU.
32. Performs other duties as assigned.
To qualify you must have a Bachelor’s Degree in Nursing, Licensure as Registered Professional Nurse in NY State with current registration and BLS Certification. Must have worked in oncology clinical research for a minimum of 5 years. Must have worked as a licensed nurse (RN or APP) for a minimum of 5 years. Must have a minimum of 3 years of management experience in a health care setting. Demonstrates competence in clinical trials nursing practice that includes the ability to execute complex research protocols and to assess and make critical decisions affecting research procedures. Demonstrates strong communication and collaboration skills to foster an effective partnership with faculty, staff and both internal and external stakeholders. Demonstrates a high level of knowledge in oncology and clinical research and utilizes advanced leadership skills to meet the Perlmutter Cancer Centers Clinical Trials Office mission. Commitment to team problem solving approach using a research and patient-focused model. Ability to multi-task and prioritize in a fast-paced environment. Organizational skills both to function independently and as a member of a professional team. Ability to read, understand, and follow written and oral instruction. Excellent written and oral communication skills that enable effective relationships with patients, faculty and staff. Excellent presentation skills. Excellent judgment skills as reflected in the making of appropriate decisions with consistency. Basic computer skills including the use of EMR and/or scheduling software. Ability to work with diverse groups of people.
Master’s degree strongly preferred; MSN in Advanced Practice Nursing with national certification preferred. OCN certification preferred and must be obtained within first year of the role. CCRP or CCRC professional certification preferred. Experience in change management, leadership and program development and quality improvement preferred.
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU Langone Health provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $108,057.46 - $163,656.49 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.