Manager-Clinical Research Unit

The Manager, Clinical Research Unit, reflects the mission, vision, and values of NM, adheres to the organization's Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards. The Clinical Research Unit (CRU) at Northwestern Medicine is administratively directed and financially supported by the NUCATS Center for Clinical Research (CCR) at Northwestern University Feinberg School of Medicine. At Northwestern Medicine, the unit is operationally and clinically directed by the Director of Operations, Stem Cell Transplantation and Cell Therapy at Northwestern Memorial Hospital.The manager holds the authority and accountability for the management of inpatient and outpatient CRU operations, staff, and facilities including the CRU Core Laboratory.In addition, the manager facilitates achievement of CRU's goals through coordinating program development and enhancement efforts in research and education. Responsible for coordinating all business services including staff modeling, quality reporting and analysis, and financial preparation and analysis as warranted. Partners effectively with multiple stakeholders in the clinical research enterprise across both NMH and Northwestern University Feinberg School of Medicine.The manager collaborates with leadership to support innovative clinical and translation research, advance quality strategies, ensure a safe, professional and supportive work environment, facilitate timeliness of services, and enhance patient satisfaction. The manager is responsible for the performance, human resource, and quality outcomes for their defined service area or unit. The manager places the safety of the clinical research subjects, patients, and other customers as the highest priority, and demonstrates the skills necessary to meet and exceed expectations. The manager motivates the team to provide high quality clinical research, safe and compassionate patient care, and excellent clinical operations. The Manager identifies and develops organizational talent and embraces continuous learning of self and others.Responsibilities:Attracts, develops, and retains exceptional research staff providing them an environment that fosters excellence through continuous learning.Collaborates with Human Resources and other managers to ensure appropriate staffingAdvances innovative retention strategies for staffCollaboratively manages the disciplinary process when appropriateFacilitates the annual performance review processEnsure application of staffing toolsFacilitates mentoring and coaching of CRU staffManages people and resources to ensure safe and efficient clinical research operations.Collaborates with the clinical coordinators to ensure optimal staffing and scheduling practices are achieved to ensure safe research study care and study protocol integrity.Embeds innovative strategies to support a healthy practice environment thatencourages break time and reduces worker fatigueWith NUCATS CCR, ensures clinical research best practices and study billing compliance are in alignment with the SOPs of the Northwestern Medicine Office of Research.Ensures compliance with all applicable federal, state, and institutional regulatory guidelines related to clinical research and affiliate operations.Reviews and updates comprehensive standard operating procedures (SOPs) for all CRU staff and study team personnel utilizing the unitPartners with the clinical and non-clinical support services departments to ensure optimal scheduling and throughput practicesSupports care coordination and response to operational issuesEnsures sustained Control phase of DMAIC for all process improvement initiativesPerforms assessments and evaluations to determine approach to implementation of new processes, protocols, and proceduresSupervises process of new study submissions, regulatory compliance review, and utilization review.Responsible for Environment of CareIdentify processes and outcomes which are important for customer satisfaction, technical quality, regulatory compliance or other institutional priorities.Customer Focus:Clearly identifies the internal and external customer(s) for their unit or service area and their respective requirements/expectations.Actively seeks methods of concurrent and retrospective feedback from customers, listens to customer feedback and implements solutions and/or interventions as appropriate.Creative Leadership:Translates organizational vision into a unit or service area vision that engages staff in contributing to and achieving that vision.Coaching and Development:Provides daily, just-in-time feedback to improve the performance and self-esteem of staff.Tracks coaching discussions and actual performance of associates to ensure accountability.Seeks ways to match staff members' talents and career interests with organizationalopportunities.Continuous Learning:Continually examines ways to improve business relationships with customers, suppliers, community, etc.Seeks and is open to new ideas from a wide range of sources; encourages others toshare knowledge and best practices. Additional FunctionsClinical Research Unit, Inpatient and Outpatient areas:Ensures all staff and shifts have appropriate training, education, supervision and monitoring to ensure effective, safe, efficient, productive and high-quality operations.Ensures a safe high quality work environment for the delivery services and clinical research support.Collaborates effectively with multiple stakeholders across institutions in a matrixedacademic environmentEnsures regulatory and policy standards are adhered to in all operationsIdentify and manage cross-project dependencies and resolve conflicting priorities.Facilitate and ensure cross-functional resource support for projects.Advocates the use of effective and proven project management, quality process improvement methodologies and budget management techniques to support defined project objectives on-time and on-budget.Coordinates the development and execution of the operational/system implementation, and communication plans for various clinical research projects.Develops and maintains relationships with all customers including staff, researchers,study coordinators, physicians, vendors, and others as needed.Implements and monitors the unit or service area's operating budget to achieve defined targets established by NUCATS.In collaboration with NUCATS, provides data for the annual operating budget and is accountable for providing NUCATS with monthly financial performance data from NM Strata.In collaboration with NUCATS, creates and implements capital requests, replacements and departmental projectsPartners with the leadership at both NM and NUCATS to advance improvement initiatives and opportunities