Department: MED-Clinical Trials Unit Salary/Grade: EXS/7
Under the direction of the Bluhm Cardiovascular Institute Clinical Trials Unit (CTU) Research Design Manager and the Administrative Director, the position will be responsible for all regulatory matters concerning the protection of human subjects for studies conducted in the Clinical Research core. This position oversees the submission process to the Institutional Review Board (IRB) of new studies being processed through the CTU, with a particular focus on highly complex protocols involving more than minimal risk to research subjects. The submission process includes completion of extensive, detailed forms summarizing all aspects of a research study as well as the development of new research subject consent forms. This is made possible by the Senior Regulatory Coordinator’s ability to read and interpret highly specialized research protocols, by negotiating with study sponsors and through understanding of federal regulations governing medical research. Usually acting on behalf of Principal Investigators, this position will be responsible for subsequently addressing IRB concerns, questions and requests’ regarding any aspect of a clinical research study until approval is received. This position will serve as the prime contact liaison between the Principal Investigators, sponsor companies, and the IRB. This position will manage the development of regulatory operating policies and procedures for the Clinical Research core. This position will provide expertise to Investigators on regulatory policies guidelines, compliance reporting, and submissions.
Manages submission of all regulatory documents to the IRB, including development of informed consent forms and protocol review for complex studies involving more than minimal risk to research subjects. Works independently to complete high-acuity protocol reviews with little need or no need for guidance from investigators and/or Clinical Research Associates. May prepare Clinical Research Unit (CRU) applications, IND applications and renewals. Corresponds with the FDA throughout the IND process. Submits study renewal applications and study progress reports to the IRB.
Trains research staff regarding process of submissions in eIRB. Provides guidance on form preparation and submission and informs Research staff of critical process and policy issues.
Negotiates study budget with sponsoring agency. Works with NMH Office of Research, NU Office of Sponsored Research and NMG research personnel to fully develop the internal study budget and contract for appropriate services.
Interprets existing and/or new regulatory requirements, developments and Institutional Regulatory Policies as they relate to human subjects research in order to effectively communicate regulatory requirements to the research staff. Maintains current knowledge of federal and institutional guidelines and requirements governing research. Recommends and implements regulatory process improvements.
Develops and manages the internal monitoring auditing program. Schedules, prepares and participates in all internal and external program audits (monitoring visits), interacts with regulatory agents, and Sponsor monitors. Ensures regulatory binders are well-maintained, organized and complete.
Communicates with IRB and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions. Monitors study closure activities and coordinates project close-out with study sponsors, investigators and the IRB.
Tracks study approvals and expirations to ensure uninterrupted project approval. Maintains regulatory database and manages electronic filing of all regulatory documents.
Performing other related duties as required or 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; OR appropriate combination of education and experience.
Three year’s of work experience in a regulatory and/or medical research environment having developed a strong working knowledge of clinical research protocols or other relevant experience required.
Minimum Competencies: (Skills, knowledge, and abilities.)
ATTDET - Attention to Detail Consistently displays accuracy and attention to detail
COW - 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.
ORG - 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
PRS - Problem Solving Formulates realistic plans and contingencies and establishes appropriate measurements of anticipated results.
RER - Research Regulations Demonstrates knowledge of federal and state regulations governing the participation of human and animal research subjects
TEAM PLA - Team Player Seeks to build collaboration by encouraging trust, mutual respect and shared purpose among various participants in an engagement.
Master’s degree preferred.
One year or more of experience managing staff.
Knowledge of or experience in NIH grant writing, applications, administration.
Preferred Competencies: (Skills, knowledge, and abilities)
Previous interaction with IRB.
One year of work experience in a regulatory and or medical research environment having developed a strong working knowledge of clinical research protocols.
Clinical experience or knowledge with an emphasis in the cardiovascular area
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Hiring is contingent upon eligibility to work in the United States.
Internal Number: 37380
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.