Northwestern Medicine · 6 hours ago
Research Compliance Coordinator
Chicago, IL
Full-time
Onsite
Senior Level
7+ years expNorthwestern Medicine is a leader in the healthcare industry focused on patient-first interactions. The Research Compliance Coordinator ensures compliance with federal, state, and local laws regarding clinical research, conducts audits, and provides education and training to clinical researchers.
Emergency MedicineHealth CareHospitalMedicalNutritionRehabilitation
Responsibilities
Conducts routine and for-cause medical chart and billing audits to assess research compliance with medical record documentation and research coding/billing; Compiles and analyses data; Provides trends/conclusions with recommendations to OOR manager and SVP of Medical Affairs
Investigates issues hindering institutional research compliance and works with NMH departments to educate/train staff and modify behavior; Evaluates instances of non-compliance with further investigation and overseeing follow up and resolutions including corrective action
Reviews all Institutional Board (IRB) applications to ensure compliance with hospital policies, and applicable federal/state research laws; Presents high risk studies to Sr. VP of Medical Affairs/Human Subject Protections Officer for determination; Endorses IRB applications for SVP when all requirements are met
Performs comprehensive clinical trial coverage analysis on each IRB application to determine what items/services are billable to Medicare (or other payers) before the study begins enrollment at NMH; Utilizes extensive clinical expertise and knowledge of all medical specialties/ancillary departments in performing coverage analyses:
Conducts comprehensive review of consent form, Clinical Trial Agreement, study budget and protocol schema to ensure consistency with billing template
Provides a billing template to the researchers to ascertain items and services associated with the project are billed to the proper parties
Provides guidance to researchers regarding alerting subjects to their financial liability
Facilitates [with NU, NMH OGC, Materials Management and Sr. Administration] placement/lease agreement execution for non-NMH owned research equipment
Provides consultation to clinical researchers to complete various NMH ancillary processes prior to subject enrollment
Analyzes emerging Federal/State regulations; Serves as knowledgeable compliance resource to research campus including Northwestern University Faculty, NMH/NMPG Physicians and NU/NMH support staff
Supports and assists Office of Research Manager in identifying and assessing areas of research compliance risk for NMHC
Reviews adverse event and protocol violation reports received by Office of Research, and where applicable notifies risk management; Collaborates with Patient Financial Services and OOR Research Financial Coordinator to ensure that appropriate payers are billed
Performs scheduled and ad-hoc educational sessions/presentations to clinical researchers
Assists with collection, analysis and reporting [to NMH Sr. Administration] of quarterly Office of Research process and outcome metrics pertaining to clinical research compliance
Collaborates with Medical Staffing Office to ensure appropriate privileging of Research Physicians/ Research APN
Functions as a member on the Northwestern University Institutional Review Board
Assists in the development and/or revision of written policies, procedures and guidelines
Develops and maintains information related to position function on department web page
Database maintenance
Monitors and tracks status reports of all current activity
Promotes professional development through increased responsibility, individual accountability and continuing education
Performs additional duties as required by Office of Research Manager and upon ad-hoc request by Director of Medical Affairs
Qualification
Required
Bachelor's degree in clinical healthcare field with 7-10 years of clinical experience, and at least 3 years of active experience in the field of research compliance
Extensive knowledge of Medicare Clinical Trial Policy regulations and Medicare Qualifying Clinical Trial guidelines
Mastery of utilization/payor management and level of care guidelines and familiarity with billing regulations and standards relating to compliance/reimbursement regulations
Proficiency in data analysis
Demonstrated consistency and reliability in level of output with focus on accuracy and thoroughness
Meticulous organizational skills
Preferred
Master's degree trained nurse (MSN) with 3-5 years of clinical research administration/compliance experience
Federal experience related to Centers for Medicare and Medicare Services (CMS) and Illinois Department of Public Aid
Benefits
Tuition reimbursement
Loan forgiveness
401(k) matching
Lifecycle benefits
Company
Northwestern Medicine
Northwestern Medicine is the collaboration between Northwestern Memorial HealthCare and Northwestern University Feinberg School of Medicine around a strategic vision to transform the future of health care.
10001+ employees
H1B Sponsorship
Northwestern Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (75)
2024 (66)
2023 (70)
2022 (78)
2021 (35)
2020 (39)
Funding
Current Stage
Late StageTotal Funding
$25M2018-06-26Grant· $25M
Leadership Team
Howard Chrisman, MD
President and CEO
John A. Orsini, CPA
Senior Vice President and Chief Financial Officer
Recent News
2026-01-13
Near North Health
2025-12-01
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