Overview

Under the direction of the AVP for Research Administration, the Manager, Quality Assurance and Regulatory Affairs is responsible for the development and oversight of all regulatory, compliance, quality assurance and educational components of the research enterprise at Wellstar Health System. This includes all system-affiliated facilities (i.e. hospitals, surgery centers, physician practices, administrative offices, etc.) engaged in clinical research including exempt and non- exempt research with human subjects. This role requires expertise in federal laws pertaining to the contracting of research services to integrated and affiliated physicians, and Common Rule (45CFR46), Food and Drug Administration (FDA) regulations, International Council on Harmonization (ICH) Good Clinical Practice Guidelines, and other relevant requirements and guidelines related to the ethical study of human research subjects. The Manager possesses a commitment to advancing System research goals in promoting the culture of conscience for the ethical conduct of human subject research throughout the System. This position serves as a resource providing guidance to the research community on regulations which govern the areas of conflict of interest, human subject research, research misconduct and responsible conduct of research, and ensures appropriate review/routing/approval of all system research activities for required approvals.

Responsibilities

Core Responsibilites and Essential Functions

Regulatory Oversight and Administration

• Exercises responsibility, on a day-to-day basis, for WellStar's Research program for protecting human subjects
• Oversees the response to all inquiries from the Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA)
• Facilitates support for Institutional Review Board (IRB) and Privacy Board review and approval, Data Safety Monitoring, Scientific Review, Research Advisory Board and Ethics Committee (and additional functions of human subjects protections and research integrity (as such committees and boards may be established)
• Ensures the IRB is informed of the status of all research protocols (45 CFR ?46.103(b)(5))
• Ensures random and/or targeted audits, monitoring, and quality assessments of human subjects research activity including affiliated IRBs are performed.
• Advises leadership (i.e., Institutional Official, Research Administration, Compliance, Legal, IRB Chair/Members, etc.) on key matters regarding research with human subjects
• Support WellStar?s Research program?s functions, committees, boards and researchers through interpretation of federal and state laws and regulations, and institutional policy and procedure
• Manage external IRB agreements and IRB reliance, as well as the front-end and back-end processes that support these agreements
• Oversee human research protection functional responsibilities such as serving as the reporting representative to the Compliance Committee and Audit Committee, defining the reporting of serious or continuing noncompliance in human subjects

Ensure system wide adherence to federal regulations pertaining to IRB oversight of all human research including policies, procedures, guidance manuals, and WellStar's Federalwide Assurance (FWA)
* Oversees all system human research projects and routing to appropriate system leaders for approval
* Oversee the continuing quality improvement of services pertaining to human subjects research for the Institutional Review Board, Investigators, and Research Personnel
* Provide guidance regarding the interpretation of regulations, laws, and policies to WellStar researchers, staff, and administrators
* Assist with research related accreditation requirements in all system programs
* Streamline research reviews (scientific, operational, financial and ethical) and approvals process to ensure timelines to activation are met
* Improve physician relations by fostering interest and assuring regulatory adherence in research participation in both employed and independent physicians
* Monitor key trends and regulatory changes/advancements in the industry
* Provide tools to the system for standard operating procedures regarding investigator-initiated research including comparative care and quality improvement
* Develop, maintain and facilitate research collaborations and partnerships with industry leaders, academic and government institutions
* Work closely with system leaders and legal department on all human research issues and COIs
* Performs other activities pertaining to human subject protection as delegated by the Institutional Official, Offices of Compliance and Legal, and/or Senior Leadership.

• Research Compliance
  * Develop and implement changes in process and policy issues and provide guidance in meeting regulatory requirements.
  * Oversee the monitoring of all research studies to maintain accurate regulatory compliance with all aspects in accordance with federal regulations.
  * Ensure the dissemination of research compliance and regulatory guidance material as needed.
  * Utilize Good Clinical Practice (GCP) and International Council for Harmonization (ICH) principles in all activities.
• Quality Assurance
  * Ensure quality assurance on an ongoing basis by overseeing scheduled and ad hoc audits of research studies.
  * Develop and implement corrective action plans strategy and communication process for staff.
  * Develop and implement an action plan accountability process for appropriate entities, e.g. IRB, Compliance, study sponsor.
• Research Education
  * Work with WHS Organizational Learning department to maintain a research education program for the system to educate staff and investigators about human subject?s research (GCP and CITI), bio-safety, data use and ownership, etc.
  * Monitor mandatory human subject?s education certification/recertification of all personnel as required.
  * Promote education of current regulatory information by analyzing interpreting and disseminating highly technical research regulatory information in an applicable manner
  * Coordinates and periodically evaluates activities to enhance the public?s understanding of research via educational outreach programs.
  * Maintain current knowledge of human subject?s protection program guidance and regulations as they evolve.

Required for All Jobs

• Performs other duties as assigned
• Complies with all WellStar Health System policies, standards of work, and code of conduct.

Qualifications

Required Minimum Education

• Bachelor's Degree from an accredited institution 

Preferred Education

• Master's Degree from an accredited institution 

Required Minimum Experience

• Minimum 8 years of regulatory, compliance and quality assurance experience. 
• Must include clinical trials regulatory experience and 1 year managing direct reports. 
• Experience in human subjects research protections, IRB regulations, and all federal and state requirements pertaining to the conduct of human subjects research 

Required Minimum Skills

• Possesses knowledge of all aspects of human protections for research subjects.
• Demonstrates a working knowledge the Federalwide Assurance.
• Must be well-versed in the accreditation standards as promulgated by the Association for the Accreditation of Human Protection Programs.
• Ability to self-direct and appropriately delegate. Ability to exercise judgments, problem solve and make decisions consistent with WellStar philosophy, goals and objectives.
• Ability to build credible relationships internally and externally, and lead through influence.
• Possesses ability to communicate both verbally and in writing clearly and concisely.
• Uses effective presentation and meeting techniques (agendas, time management, etc.).
• Strong computer experience necessary.
• Strong analytical and problem-solving skills.
• Excellent interpersonal and organizational skills, good oral and written communication skills.

Required Minimum License(s) and Certification(s)

• Certified IRB Professional Required

Preferred Licenses and Certifications

• Certification in Healthcare Research Compliance (CHRC)