Manages regulatory operations of biomedical &/or social-behavioral research studies involving multidisciplinary teams of colleagues, sponsors & other external project stakeholders for the Dermatology Clinical Trials Unit (CTU). Helps gather regulatory documents for signature and PI-signed forms and files into electronic regulatory binder system (Complion). Submits new studies to the IRB (NU and Lurie IRBs), drafts consent forms/other study-related documents for IRB submission. Submits IRB modifications, continuing reviews, and RNIs. Reviews study protocol deviations/NTFs/AEs/SAEs and helps draft any required formal responses to IRBs and/or sponsors and/or FDA. Tracks all team IRB submissions/deadlines. Enters new project details into NU FSM Clinical Trial Management system (Study Tracker). Updates team trackers daily with new/open study updates. Submits new studies to CT.gov. Enters updates/results for open studies in CT.gov. Performs regular quality assurance binder/data checks on assigned studies. 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).

Specific Responsibilities:

Technical

• Leads execution & control of a biomedical &/or social science project or research study.
• Develops new &/or revised research methodologies.
• Ensures completion of study activities per protocol including recruitment.
• Collects data from medical records.

Administration

• Oversees & manages collection, maintenance, analysis & evaluation of data that will be used in grant submissions, presentations & publications.
• Ensures that information is entered correctly into databases.
• Assists PI in reviewing, analyzing, interpreting, summarizing, formatting, editing, & preparing tables, charts, graphs, progress & final reports, etc.
• Coordinates between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.
• Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.

Finance

• Orders & maintains inventory of study supplies.

Supervision

• Trains, directs, assigns duties to & supervises research staff, students, residents &/or fellows.
• Acts as a mentor in regard to education of junior coordinators.

Miscellaneous

• Performs other duties as assigned.

Minimum Qualifications:

• 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 3 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.
• Human subjects research/IRB submission experience required.
• Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years

Minimum Competencies: (Skills, knowledge, and abilities.)

• Microsoft Teams, Outlook, & REDCap
• Oversee IRB/regulatory operations for industry, foundation or federally funded research
• English language fluency with an engaging personal style for subject and staff interaction

Preferred Qualifications:

• Recent (within the last year) experience with industry or federally funded clinical research with excellent references
• Certification as a clinical research coordinator

Preferred Competencies: (Skills, knowledge, and abilities)

• Word Processing/Microsoft Office
• Self-motivated learner
• Adept at problem solving with the ability to clearly summarize the situation and offer a range of solutions.
• Prior experience with NU/Lurie IRB systems (Cayuse, eIRB+) or similar
• Prior experience with electronic regulatory filing systems (Complion) or similar

Benefits:
At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.

Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life’s challenges and opportunities, and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you’re interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.

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