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Human Subjects Compliance and Privacy Officer (req2145)

Company: Frederick National Laboratory
Location: Frederick
Posted on: October 7, 2021

Job Description:

PROGRAM DESCRIPTION

Leidos Biomedical'sEthics and Compliance Directorate is a centralized function for ethics, auditing, corporate compliance, and business process functions.

This position will provide administrative oversight and support for human subjects and privacy related compliance activities at the Frederick National Laboratory for Cancer Research. The position will be expected to work closely with FNLCR researchers and their staff to ensure compliance with human subjects research regulations and with applicable privacy requirements. The position will be responsible for communicating contract requirements to staff on human subjects research and the use of human derived materials in research. Investigates and reviews issues of non-compliance as appropriate in conjunction with other members of the Ethics and Compliance team.

KEY ROLES/RESPONSIBILITIES

  • Analyze and review requests for Intuitional Review Board (IRB) exemption determination to ensure completeness of information in support of the request and compliance with applicable federal laws and FNLCR procedures
  • Determine whether research projects are exempt from further review; review and approve certain research projects , as appropriate, in making the exemption determination
  • Communication with researchers about exemption documentation and other requirements, including study documentation from collaborator, informed consent documentation and request additional information as needed
  • Communicate with NIH/NCI IRB office as needed to establish reliance agreements as appropriate
  • Maintain active knowledge of policy and regulatory changes related to human subjects research
  • Update internal policies and procedures regularly based on changes in NIH policy, contract changes or applicable federal regulation changes
  • Update senior management on regulation changes and policy changes
  • Develop and participate in training and educational activities on human research protections that are presented to researchers and administrative staff
  • Maintain training records relating to FNLCR staff training on human subjects
  • Provide training on the handling, use and storage of PHI and privacy issues
  • Maintain and update the FNLCR Federal Wide Assurance (FWA) on the OHRP website
  • Serve as the point of contact for all questions related to exemption determination relating to human subjects
  • Work with FNLCR research collaborators to obtain records and documentation for compliance with contract requirements
  • Collect and keep documentation according to record retention guidelines
  • Work with CLIA certified labs to review handling of PHI (including updating checklists for audits) within the laboratory on an annual basis to ensure compliance with federal requirement
  • Support other areas of related research compliance

PRIVACY
  • Work closely with IT on data protection issues related to proper handling of PII and PHI at FNLCR
  • Providing education and training to various administrative department, including but not limited to, subcontracts on handling PHI received in the workplace from subcontractors
  • Provide training as necessary to all staff on the proper handling of PII and PHI and serve as the POC to administrative departments on how to handle PHI
  • Demonstrates extensive knowledge of federal regulations regarding the protection of human subjects participating in research including HIPAA (Privacy and Security Rule, HITECH), FDA drug, biologic and device regulations
  • Knowledge of federal regulations regarding the protection of human subjects participating in research and other areas of research compliance
  • Monitor and analyze current and proposed federal and local regulations and policies and recommend changes in institutional policies and procedures to ensure compliance
  • Maintain effective, collaborative working relationships with other business areas including Internal Audit, Legal and other relevant offices within Leidos Biomedical and at Leidos
  • Champion research integrity and ethics standards with LBR researchers. Develop and deliver effective employee communication, outreach and training programs to strengthen awareness and knowledge around all aspects of research integrity, ethics in research and responsible conduct of research practices
  • Emphasize and embody ethical conduct, impartiality, teamwork, continuous improvement, and best practices in your work

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet theknowledge, skills, and abilities listed below:
  • Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirement, a minimum of five (5) years of progressively responsible experience related to human subjects and privacy related compliance activities
  • Ability to obtain and maintain a security clearance


Keywords: Frederick National Laboratory, Frederick , Human Subjects Compliance and Privacy Officer (req2145), Other , Frederick, Maryland

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