Research Compliance Coordinator

The Research Compliance Coordinator reflects the mission vision and values of Northwestern Medicine adheres to the organizations Code of Ethics and Corporate Compliance Program and complies with all relevant policies procedures guidelines and all other regulatory and accreditation standards.

The Research Compliance Coordinator monitors and assures that clinical research at NMHC is in compliance with all aspects of federal state and local laws and regulations and NMH policies. This role performs routine and for-cause audits of research clinical documentation and billing records ensures resolution of deficiencies and performs education and training of clinical researchers and NMH unit staff.

The Research Compliance Coordinator conducts financial coverage analysis for NMH services used in University human subject research studies and identifies potential research compliance vulnerability for NMHC.

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

Additional Functions:       

• Performs additional duties as required by Office of Research Manager and upon ad-hoc request by Director of Medical Affairs

Qualifications :

Required:                 

• Bachelors 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:                  

• Masters 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

Additional Information :

Northwestern Medicine is an equal opportunity employer (disability VETS) and does not discriminate in hiring or employment on the basis of age sex race color religion national origin gender identity veteran status disability sexual orientation or any other protected status.

Background Check

Northwestern Medicine conducts a background check that includes criminal history on newly hired team members and at times internal transfers. If you are offered a position with us you will be required to complete an authorization and disclosure form that gives Northwestern Medicine permission to run the background check.  Results are evaluated on a case-by-case basis and we follow all local state and federal laws including the Illinois Health Care Worker Background Check Act.

Artificial Intelligence Disclosure

Artificial Intelligence (AI) tools may be used in some portions of the candidate review process for this position however all employment decisions will be made by a person. 

Benefits

We offer a wide range of benefits that provide employees with tools and resources to improve their physical emotional and financial well-being while providing protection for unexpected life events. Please visit our Benefits section to learn more.

Sign-on Bonus Eligibility: Internal employees and rehires who left Northwestern Medicine within 1 year are not eligible for the sign on bonus. Exception: New graduate internal employees seeking their first licensed clinical position at NM may be eligible depending upon the job family. 

Remote Work :

No

Employment Type :

Full-time