Department: MED-Immunothrpy for Autoimm Di Salary/Grade: EXS/5
Under direction, this position coordinates and guides the review and approval process of all research activities associated with clinical research studies involving human subjects ensuring the protection of their safety, rights, and welfare. Interprets and applies rules and regulations (NU, local, state, federal, industry, sponsor, etc.) and recommends and guides principal investigators (PIs) and research staff in the creation, submission, documenting, reporting, etc. of study activities ensuring appropriate compliance.
This position collaborates with daily operations of a biomedical &/or social-behavioral research studies involving multidisciplinary teams of colleagues, sponsors & other external project stakeholders. The Regulatory Coordinator ensures that all study activities are completed by strictly following Good Clinical Practice (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).
The Regulatory Coordinator position consists of two principle duties: regulatory and recruitment. This position will interact with physicians, study staff members, and NU Clinical and Translational Sciences (NUCATS) Institute staff members. The duties include assisting with study recruitment and regulatory submissions to the NU IRB and sponsors. Interpersonal communication skills along with strong writing skills and organization are necessary to being successful in this position.
This position supports the Division of Immunotherapy and Autoimmune Disease, whose focus is devoted to research utilizing stem cell transplantation in clinical trials for autoimmune diseases and vascular diseases.
Please Note: This position would be responsible for transporting study binders around campus on a regular basis.
Determines and interprets applicable rules and regulations associated with clinical research studies and trials involving human subjects ensuring the protection of their safety, rights, and welfare. Guides and coordinates all associated submission, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-out, etc.) recommending alternatives to ensure compliance and approval.
Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and internal/external regulatory and oversight groups (NU’s IRB, sponsors (NIH, industry), government agencies (FDA), etc.) to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite research while ensuring compliance.
Determines compliance required documentation and drafts necessary items such as protocols, informed consent, etc. Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers.
Provides guidance and training to research staff to ensure compliance with complex, highly specialized rules and regulations associated with clinical research studies and trials involving human subjects.
Creates reports, summaries and analysis in regard to compliance requirements recommending changes in practice or procedure to increase effectiveness and efficiency of compliance.
Researches new and updated rules and regulations associated with clinical research studies and trials involving human subjects. Alerts appropriate staff to changes and ensures appropriate interpretation and application to new and existing studies and trials.
Completes other duties as required.
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 social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR
Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 1 year research study or other relevant experience.
Knowledge of medical terminology.
Minimum Competencies: (Skills, knowledge, and abilities.)
Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice Guidelines.
Skill/knowledge in Microsoft Office, including Word and Excel; skill/knowledge of database management, and file management.
Preferred Qualifications: (Education and experience)
One year experience in human subjects’ research, clinical trials, or regulatory knowledge.
A bachelor’s degree in English, social or health sciences.
Preferred Competencies: (Skills, knowledge, and abilities)
Action oriented - Willing or likely to take practical action to deal with a problem or situation.
Coachability - Receptive to feedback, willing to learn, embracing continuous improvement.
Collaboration - Facilitates open and effective communication, cooperation and teamwork within and outside of one's own team.
Collegiality - Helpful, respectful, approachable; builds strong working relationships and a positive work environment.
Initiative - Exhibits energy and desire to achieve; sets ambitious goals and acts decisively; takes action that no one has requested to improve or enhance job results and avoid problems.
Meets deadlines - Displays consistency and success in adhering to deadlines.
Multi-tasking - Demonstrates ability to work on multiple projects simultaneously.
Organization - Plans, organizes and schedules in an efficient, productive manner; anticipates contingencies and pays attention to detail.
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: 36068
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.