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Assistant Director of Quality Assurance and Compliance

Employer
Virginia Commonwealth University
Location
Virginia, United States
Salary
Salary Not Specified
Date posted
Apr 7, 2022


Summary:

Massey Cancer Center

“To improve the lives of all Virginians by delivering cutting-edge cancer care through patient-centered prevention and treatment; high-impact, innovative research; community input and engagement; and education and training of the next generation of researchers and healthcare professionals.”

Virginia Commonwealth University (VCU) Massey Cancer Center is a nationally ranked cancer center located in the heart of Downtown Richmond. All full-time staff are eligible for our generous benefits package that includes choices for health, vision, and dental coverage, life-insurance, short and long-term disability coverage, retirement planning, tax-deferred annuity and cash match programs, flexible spending accounts, tuition benefits, significant paid-time off,12 paid holidays, and more. Explore our benefits further here: https://hr.vcu.edu/current-employees/benefits/university-and-academic-professional-benefits/

The Senior Manager/ Assistant Director Quality Assurance and Compliance will report into the Senior Director Clinical Operations and Management of the Massey Cancer Center (MCC), Clinical Trials Office (CTO) with a dotted line report into the Associate Director for Clinical Research and may have up to two additional auditors in the Quality Assurance and Compliance Unit. This position provides coordination for the administration, support, auditing, and oversight of operational research compliance functions for the MCC. These functions include protection of human subjects; export controls; research involving radiation, biorepositories, biohazards, and controlled substances. This position participates in all aspects of research integrity, compliance, and privacy initiatives, including workforce orientation, incident response & documentation, research compliance and investigations, educating stakeholders on research compliance topics, and supports policy and procedure development. The incumbent also works with institutional officials in Conflict of Interest disclosure/reporting process.

Typical Duties
  • Conduct MCC Clinical Research Enterprise wide compliance audits to ensure data integrity, compliance with federal and state regulations pertaining to but not limited to: federal research program requirements, coding and documentation, and all aspects of clinical trials.
  • Interpretation of applicable federal and state law & regulations to plan audit parameters, determine department's compliance with such regulations, and communicate to department necessary changes in compliance with regulatory requirements.
  • Manage Clinical Research Enterprise-wide response to external audits (NCI and pharmaceutical) to ensure data integrity and completeness of records and accuracy of data, compliance to regulations, standard procedure and policies and protocols.
  • The Quality Assurance Auditor completes, revises and reviews the requirements necessary to attaining and maintaining compliance with the FDA and other regulatory bodies for clinical trial research both from a documentation and process level. Promotes adherence to ICH-GCP guidelines, ensures that data reported is accurate and complete and guarantees that the rights and safety of participants in clinical research are protected. This is accomplished by serving as a resource for the staff of the Massey Cancer Center Clinical Trials Office enterprise and working closely with the Regulatory, Activation and Quality Control Monitoring Unit.
  • QA auditors perform eligibility verifications and chart reviews. Are responsible for preparing for NCI and NCTN audits.
  • QA Auditors are an integral part of the infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial education efforts in collaboration with the Sr. Manager/Assistant Director of Training and Education.
  • Review and test for compliance with institutional policies and procedures, applicable laws and regulations through the inspection of operations, processes, retrieval, and review of documents and investigation of irregularities and errors.
  • Ability to be flexible, multitask and switch priorities as well as work comfortably in a deadline-driven / productivity environment.Ability to prioritize, organize, plan, and implement services as well as handle multiple projects/problems simultaneously. In-depth knowledge of federal regulations around clinical trials, Cerner, EPIC, OnCore, and Microsoft Office experience preferred.
  • Duties and Responsibilities of this Level:
  • Leads, develops, and maintains compliance project work plans, timelines, and milestones.
  • Maintains independence, confidentiality, and objectivity related to integrity and compliance matter review and assignments.
  • Leads or assists in development of quarterly and/or annual research compliance reporting to senior leadership and applicable review committees.
  • Performs work in an ethical and safe manner.
  • Responsible for conducting clinical trial compliance audits, documenting & communicating findings and recommendations, explaining regulatory requirements, and overseeing the corrective actions for external audits
  • Conduct risk assessments and preparation of work plans.
  • Develop an understanding of the operations, system processes, and procedures used in areas being audited.
  • Actively participates in exit conferences, providing clarification, and supporting information necessary.
  • Compile information and/or prepare reports and analyses setting forth results of compliance audits with appropriate recommendations; perform subsequent audits to ensure complete and appropriate
  • Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU
Minimum Hiring Standards
  • 5 years of experience related to legal, regulatory compliance auditing, clinical research, or health information management services.
  • Prefer experience in clinical research, familiarity with oncology protocols, clinical trials operations, GCP, NCI guidelines and federal regulations both FDA and HHS.
  • Experience with Cerner, EPIC, RedCAP and OnCore is preferred. Knowledge and familiarity of e-regulatory systems (Veeva), DocuSign, ImageNow and other applications used in the conduct of clinical research along with the relevant regulations is highly preferred
  • 5 Years’ experience in clinical trials auditing
  • 2 Years’ experience in oncology License/Certifications
  • CCRC - Cert Clin Research Coordinator or
  • CCRA - Cert Clin Research Associate or
  • CCRP - Cert Clin Research Prof
  • Bachelor's degree in business administration, accounting, management, healthcare administration, science, nursing, or other related degrees.
Preferred Hiring Standards
  • Combination of relevant education and experience may be considered in lieu of degree. Experience 2-5 Years’ experience as a Clinical Research Associate, Clinical Research Coordinator, Clinical Research Nurse Coordinator and proven experience as an Lead Auditor
Salary Range: commensurate with experience



Position Details:

Department: Massey Cancer Center
Employment Type: UF - University Employee FT
Restricted Status: No
FTE: 100
Exemption Status: Exempt




Contact Information:

Contact Name: India Sisk

Contact Email: jonesir@vcu.edu

Contact Phone: 804-628-7294




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