The Research Compliance Coordinator reflects the mission, vision, and values of Northwestern Medicine, adheres to the organization’s 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
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