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Position Title:
REGULATORY COMPLIANCE AND ETHICS MANAGER /WARM BASE
Position Number:
042
Project Worksite:
Central Office/AMD (1 position)
Deadline for submission: Friday, October 13, 2023, at 5:00pm Liberia Time
About PREVAIL:
PREVAIL, or the Partnership for Research on Vaccines and Infectious Diseases in Liberia, is a clinical research partnership between the U.S. Department of Health and Human Services and the Liberian Ministry of Health
Summary of Position:
The Office of Regulatory Compliance and Ethics oversees all regulatory compliance and ethics issues across all PREVAIL sites. The Regulatory Compliance and Ethics Manager will provide oversight and will coordinate site performance on all PREVAIL activities regarding adherence to regulatory requirements, ethical standards, and best practices. S/he will provide oversight in maintaining the integrity of clinical research, protecting the rights and safety of research participants, and upholding the organization’s reputation.
Description of Responsibilities:
General Administrative:
• Oversees the responsibilities of the members of the regulatory compliance team.
• Develops work plans in accordance with the annual work plan of PREVAIL.
• Serves as the lead representative of the Regulatory Office at key PREVAIL Operations and Working group meetings.
• Serves as the lead liaison/point of contact for ethics committees and regulatory authorities to ensure timely review and approval of all PREVAIL submissions.
• Collaborates with the protocol teams, Ethics Committee(s) and/or regulatory authorities to ensure that research protocols and informed consent processes comply with regulatory and ethical requirements and safeguards the rights and welfare of research participants.
• Provides guidance to PREVAIL, site managers, study coordinators, and the regulatory compliance team members regarding all regulatory aspects and requirements and assists the sites in resolving said issues.
• Mediates and addresses conflicts or disagreements within PREVAIL reading regulatory compliance and ethics.
• Keeps management informed about regulatory and ethical developments, changes, and potential organizational impacts.
• Oversees the maintenance of complete and accurate records of regulatory submissions, approvals, correspondence, and other relevant documentation.
• Oversees the proper management, storage, and retention of study records in compliance with regulatory guidelines. Partnership for Research on Vaccines and Infectious Diseases in Liberia (PREVAIL) Liberia – U.S. Joint Clinical Research Partnership The Mitchell Group, Inc. (TMG)
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• Assists the investigators in understanding and carrying out their ethical and regulatory responsibilities.
• Reviews and approves institutionalized standard operating procedures for Regulatory compliance and ethics.
• Oversees compliance of all clinical research activities with applicable local, national, and international regulations and guidelines, including Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and applicable laws.
• Identifies areas for process improvement in regulatory and ethical practices within the clinical research department and collaborates with relevant stakeholders to implement changes.
Regulatory Compliance:
• Provides subject matter expertise on regulatory requirements in PREVAIL.
• Monitors and interprets relevant local, national, and international regulations, guidelines, and standards related to clinical research.
• Oversees the development, reviews, implementations, and maintenance of processes and procedures (including SOPs and Policies) to ensure compliance with applicable regulatory requirements and Good Clinical Practice guidelines.
• Collaborates with cross-functional teams to ensure regulatory compliance for protocols, study materials, and documentation.
• Prepares and submit regulatory documents to the appropriate authorities as required.
• Oversees periodic internal regulatory and ethical quality control/audits across all sites to assess compliance and regulations.
• As required, oversees the resolution of queries raised during sponsor audits. Addresses any findings and implements corrective and preventive measures.
• Oversees/participates in study initiation and closure activities, ensuring compliance with all regulatory and ethical requirements.
Ethics Oversight:
• Ensures that all research activities are conducted in accordance with institutional review board (IRB) or ethics committee approvals and the highest ethical standards.
• Collaborates with the Principal Investigators and study coordinators to ensure the timely submission and review of Protocols and amendments or applications for Continuing Review.
• Facilitates the ethical review process by addressing any concerns or queries the ethics committees raise.
Risk Management/Reporting
• Identifies potential compliance and ethical risks associated with clinical research activities at PREVAIL and propose mitigation strategies.
• Guides the study teams in risk management, including timely adverse event reporting [to the ethics committee, regulatory authorities and sponsors], safety monitoring and data integrity.
Training and Education
• Collaborates with L&PD on Good Clinical Practice and other Human Participant Protection training across the sites.
• Designs and implements training programs to ensure research staff are well-informed about regulatory compliance and ethical considerations.
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• Promotes a culture of awareness and accountability with regard to regulatory and ethical requirements.
 Other duties as assigned.
Qualifications
 Education: Master of Social or Biomedical Sciences, Public Health, Bioethics, Law, or other related fields
 Preferred Job-related Experience: At least five years of relevant experience.
 Additional Eligibility Qualifications: Familiarity with the bioethical and regulatory landscape, good written and oral communication skills, good computer application skills, good interpersonal skills, ability to meet tight deadlines, ability to work in a diverse environment and a good team player.
Application Instructions:
Click the apply button below