Find your purpose as the Research Compliance Officer at CentraCare! This role will lead CentraCare Health's Research Compliance Program. The Research Compliance program is designed to safeguard the welfare and rights of research subjects by following ethical standards and operating within regulatory requirements for clinical research. As the Research Compliance Officer (RCO), you will build relationships which foster a culture of integrity and accountability among researchers, research coordinators, operations staff, and other CentraCare stakeholders.

The RCO is the CentraCare principal contact and subject matter expert on a broad range of research-related policy and regulatory issues, including Conflict of Interest, Research Misconduct, Research Billing, NIH Good Clinical Practices (GCP), Human Subject Protections, ClinicalTrials.gov, Responsible Conduct of Research, and other areas related to research compliance. The RCO advises CentraCare leaders on all matters related to Research Compliance and integrity.

Schedule:

Full-time 80 hours every 2 weeks Monday-Friday 8:00a-4:30p Hybrid position; Majority remote, will need to be in-office in St. Cloud, MN for orientations, trainings, and meetings.

Pay & Benefits:

Starting pay begins at $103,590.08 per year and increases with experience Salary range:   $103,590.08 - $155,374.44 per year Salary range is based on a 1.0 FTE, reduced FTE will result in a prorated offer rate. Full time benefits: medical, dental, PTO, retirement, employee discounts and more!

 Qualifications:

Bachelor's Degree or equivalent research certification, in addition to coding/billing; Compliance experience may be substituted in lieu of degree. 5 years of clinical research or compliance experience required. If pursuing Certified Healthcare Research Compliance (CHRC) certification in lieu of experience requirement, CHRC certification must be obtained within 2 Yrs. Registered Health Information Administrator (RHIA) Certification or Registered Health Information Technician (RHIT) Certification or Certified Coding Specialist Certification or Certified Professional Coder Certification and/or Healthcare Compliance required upon hire.  Demonstrated effective decision-making, negotiation, and mediation skills. Strong supervisory experience; ability to promote team building and manage multi-functional units. Demonstrated ability to direct and lead teams to conduct audits on complex research compliance issues. Proficient in balancing regulatory compliance requirements against practical needs and limitations. Advanced management, interpersonal and communication skills. Strong oral communication, interpersonal and written skills to interact effectively with diverse populations at all levels, including researchers, staff, leadership, and governmental officials. Knowledge, understanding, and experience in development and delivery of education and effective training to internal and external clients, including effective presentations to key decision makers. Leadership experience and proven success in directing, leading and guiding compliance review boards and committees.

Core Functions:

Review all clinical research projects/studies for submission to the Institutional Review Board (IRB). Assess each proposed research project for appropriate compliance across protocols, consents, budgets and agreements. Responsible for centralized compliance oversight and review of clinical trials and clinical trial operations. Serve as principal contact/resource for investigators, research staff, IRB, and external regulators on all clinical trial topics/issues. Monitors regulatory, legal and industry developments for implementation in the compliance program. Develop and implement policies and procedures to ensure compliant practices including regulatory compliance and data management. Develop and implement policies to support correct coding, charging and billing of clinical trials. Create and maintain standardized processes for submitting clinical trials billing and financial information. Serve as liaison between investigators, ancillary departments, fiscal intermediary and clinical research departments. Support research coordinators/departments with development of budgets for clinical trials. Coordinates research compliance activities across CentraCare Health. Develops annual research compliance work plan including review and monitoring schedule.  Determines areas to be reviewed based on the priorities of regulators and the CentraCare Health entities compliance work plan. Oversees ongoing monitored reviews of research based upon identified areas of concern, recommends procedural workflow changes, and assists departmental leadership with the development of corrective action plans to ensure resolution of compliance risk. Understands, interprets, and communicates federal, state, and other third-party payer regulations for CentraCare Health research studies including but not limited to human subject research, hospital and employed physician billing rules, documentation, coding, and other regulations which govern the provision of healthcare (i.e., Common Rule, STARK, EMTALA, Anti-kickback, False Claims, etc.). Continue to advance appropriate knowledge base and skills. Serves as a critical liaison with local and federal law enforcement and public safety agencies and federal regulators (for example, ORI, NIH, HRSA, FDA, OHRP, etc.). Develop and present clinical research compliance educational programs to audiences such as providers, principal investigators, research coordinators, administrative, ancillary (clinical), coding and revenue cycle staff, as needed.  Collaborates with Leadership on periodic training and educational needs across the organization. Works with Epic Electronic Medical Record (EMR) teams to ensure maximum utilization of Epic EMR capabilities for research purposes. Acts as a point of contact for Epic application teams on research compliance issues. Establishes and maintains a process to address, manage and resolve research compliance issues, including allegations of research misconduct or noncompliance with sponsor requirements, and inquiries/complaints. Participate in assigned CentraCare Health Compliance Committees. May lead or participate in other committees as needed. Authors Executive Summaries and reports compiling audit/review results of research to a variety of staff and committees as appropriate. Complete effective compliance reviews with the primary focus on research requirements, billing, and documentation. Use analytical skills and expertise to investigate and resolve any potential research compliance issues Participate in Regulatory Audits (FDA, etc.) serving as compliance liaison assisting Principal Investigators, Research Coordinators, IRB members, Revenue Cycle personnel, etc. Completes a risk assessment for research compliance.

CentraCare has made a commitment to diversity in its workforce. All individuals including, but not limited to, individuals with disabilities, are encouraged to apply. CentraCare is an EEO/AA employer.