Research - Laboratory/Non-Laboratory, Staff/Administrative
Department: MED-Neurology Salary/Grade: EXS/8
Under the Direction of the Associate Director of Research Administration and the Neurology Clinical Research Steering Committee Chair, the Clinical Research Manager has the authority and accountability for the management of all operational, regulatory and training/continuing education activities of the Clinical Trials Unit (CTU). Specifically, the Clinical Research Manager is responsible for oversight of all administrative and operational duties of the clinical trials unit including:
Management of studies, analyzing feasibility; identifying & securing needed resources; monitoring and updating project plans and budgets; assisting with study start-up activities by determining clinical research staff effort availability; facilitating meetings with appropriate parties; monitoring & reporting progress as appropriate; ensuring resolution of problems and issues and completion of contract requirements and client specifications; human resource management; managing facilities; business development and marketing; providing direction to and ensuring integrity in data management, mining, and analysis; interfacing and ensuring compliance with granting organizations; overseeing all preparatory activities for internal and external regulatory inspections; interfacing with clinical staff to secure necessary space and resources to promote expansion of research program; on-boarding, training, and providing continuing education for clinical research staff; serving as primary Access Program liaison with the NMHC Office of Research; overseeing research program growth at CDH and LFH locations; representing Neurology on IRB and Clinical Research Advisory Council. Oversees all activities associated with clinical research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/interventions; &/or multi-million dollar budgets (examples include Investigator Initiated Trials, National Cooperative Group Trials with multiple affiliate institutions, and global Sponsored Trials.). Creates, promotes and nurtures collaborations and partnerships with other institutional departments, outside affiliates and research organizations, pharmaceutical partners, regulatory agencies, and other strategic partners.
Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).
In partnership with Principal Investigators (PIs) provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research projects ensuring that programs of investigation meet specified objectives.
Oversees management of studies including start-up, implementation, conduct, day-to-day activities, interaction with partners and sponsoring agencies, close-out; and planning, development and implementation of new processes and protocols to support research studies and maximize/extend study capabilities.
Ensures that the conduct of study protocols are in compliance with appropriate rules and regulations and reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors.
Oversees and directs the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.
Troubleshoots emergent patient care issues with clinical teams to ensure adherence to protocol guidelines, institutional reporting policies, and federal regulations.
Leads clinical teams in preparing for internal, NU IRB, Sponsor, and FDA audits.
Oversee & implement resource and allocation and necessary changes in resource utilization required for clinical trials (equipment, etc.)
Oversees the department’s Feasibility Assessment process in order to promote transparency among divisions regarding proposed clinical trials.
Determines goals, objectives, outcome measurements and metrics, and collaboration opportunities as it relates to clinical research with other internal and external organizations.
Directs actions to ensure high quality clinical research standards are maintained across all partner programs.
Provides leadership for planning, scheduling, delivering and maintaining program(s)/project(s) to sustain quality instruction in all educational activity.
Works with Northwestern Memorial Hospital (NMH) and Northwestern Medical Group (NMG) finance staff to develop strategies for tracking patient research bills and managing invoices for all research projects.
Develops and maintains Standard Operating Procedures (SOPs) for the unit’s clinical operations and continuously reviews and monitors clinical conduct and develops new, or modifies existing policy documents, SOPs, and training materials as required.
Oversees the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners. Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.
Connects study teams with the Research Administration team and NUCATS financial team for budgetary negotiations with study sponsors.
Oversees study sponsors for study tests/procedures.
Oversees the timely completion of patient specific billing requirements to ensure hospital requirements for billing compliance is met.
Reviews scientific literature and evaluates and recommends applicable techniques and procedures.
May co-author scientific papers for presentation & publication & coordinates writing, submission & administration of grants.
Liaison with Industry to bring in additional Clinical Trials.
Facilitates completion of industry-sponsored feasibility questionnaires and provides guidance to PI’s.
Connects PI’s with clinical research resources such as Investigational Pharmacy, Clinical Research Unit (core laboratory, infusion suite, inpatient unit, etc.), and MRI services.
Oversees Regulatory activities (currently outsourced to NUCATS)
Serves as a resource to investigators in preparation of grant applications, including clinical trial accrual reports, financial reports regarding staff effort and CTU services summaries.
Responsible for the maintenance of all CTU facilities and equipment to support the mission of the CTU.
Acts as liaison between institutional investigators and clinical research staff, when necessary. Acts as a liaison between the CTU and NUCATS, NU, IRB, FSM Dean’s Office, NMHC Office of Research, NMH, and NMG.
Responsible for development and maintenance of inter-institutional relationships, pharmaceutical industry representatives, federal grant administrators and auditors.
Oversees open searches for new clinical research staff positions and provides guidance regarding appropriate classification of new positions.
Trains, directs, assigns duties to and supervises research staff, students, residents and/or fellows.
Provides leadership to the staff.
Oversees and directs all recruitment activities in collaboration with appropriate PIs, management, and supervisory staff.
Responsible for implementation of the performance management system including merit review and disciplinary procedures.
Develops and directs a comprehensive program of staff development including orientation, in-services, continuing education, and staff meetings.
Oversees the NMHC Access Program for all new research staff, visiting scholars, and volunteers/interns.
Ensures that daily operations are appropriate, efficient and effective and are in compliance with improvement opportunities to enable the CTU to achieve its goals and standards.
Ensures staffing is appropriate to support trial volume.
Works with PI’s and divisions to ensure that clinical research staff effort allocation appropriately reflects staff’s time on multiple projects.
Identifies opportunities for alternative staffing, sharing resources, right sizing, and staffing to demand.
Performs other duties as assigned
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as business, accounting, healthcare administration or related field; OR appropriate combination of education and experience.
Previous experience as a clinical research coordinator and with electronic medical records systems.
Must complete Northwestern's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
Working knowledge of Clinical Trials.
Attention to Detail: Consistently displays accuracy and attention to detail.
Proven ability to lead a changing organization, including building a management team, developing initiatives and implementing improvements to drive the underlying strategy.
Proven ability to function in a complex business and compliance environment.
Excellent management and communication skills.
Ability to comprehend technical research protocols.
Knowledge of operational management, including budgeting; project management; broad knowledge of management principles and techniques.
Ability to plan, organize and execute policies and programs for a growing organization.
Strong analytical and problem solving abilities.
Ability to establish and maintain relationships across multiple organizations.
Ability to motivate and lead an organization as well as skill in dealing effectively with people at all levels.
Strong conflict resolution, change management and negotiation skills are required.
Ability to critically review reports and prepare recommendations from such review including but not limited to preparing and analyzing budgets and financial reports.
Ability to communicate clearly and concisely both orally and in writing.
Ability to make independent decisions with little oversight.
Skill in applying administrative principles in organizing and leading a complex team-based operation.
Communication-Oral and Written: Communicates effectively one-to-one, in small groups and in public speaking contexts; writes precise, well-organized emails, letters and proposals while using appropriate vocabulary and grammar.
Decision Making: Follows and teaches others to follow a process method for problem solving.
Leadership: Involves team members in solving problems and making decisions, inspires people to follow the lead, obtains input from others, facilitates change, and inspires confidence and optimism through a clear vision and by personal example.
Organization: Plans, organizes and schedules in an efficient, productive manner; anticipates contingencies and pays attention to detail; targets projects or initiatives that require special attention and focuses on key tasks when faced with limited time and or resources.
Planning: Devises and implements clearly defined strategies to achieve business objectives.
Problem Solving: Formulates realistic plans and contingencies and establishes.
Preferred Qualifications: (Education and experience)
A master's degree
Internal Number: 38791
About Northwestern University
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.