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Position Title:
REGULATORY COMPLIANCE AND ETHICS COORDINATOOR/WARM BASE
Position Number:
049
Project Worksite:
Central Office/AMD (4 positions)
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 PREVAIL Office of Regulatory Compliance and Ethics will oversee all regulatory compliance and ethics issues across all PREVAIL sites. The scope of responsibility will include but is not limited to assisting the Regulatory Compliance and Ethics Manager in the discharge of all regulatory compliance and ethics functions assigned to the Office.
Description of Responsibilities:
General Administrative/Documentation:
• Maintains accurate and up-to-date records of regulatory submissions, approvals, correspondence, and other relevant clinical research-related documents.
• Populates/Maintains office trackers or platforms for all incoming and outgoing regulatory and other documents and activities, including protocol expiration, licenses, GCP and Human Participant Protection Certificates, Standard Operating Procedures, etc.
• Performs electronic and physical filing of regulatory documents (effective and ongoing communication with sponsor, research participants, Principal investigator, relevant ethics and regulatory authorities) using appropriate filing systems and cabinets.
• Drafts Regulatory Compliance and Ethics Standard Operating Procedures for institutionalization.
Protocol Preparation and Review
• Participates in the institutional review process of research protocols, ensuring compliance with ethical and regulatory standards.
• Tracks protocol development from conception to final approval.
• Develops trial-related documents and operational procedures in collaboration with the Principal Investigator and the clinical staff.
• Prepares and delivers hard copies of any regulatory submission documents required by the protocol to the appropriate authorities. 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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• Collaborates with the Study Coordinators to establish and organize study folders, including regulatory binders and other documents.
Research Conduct and Training
• Ensures that all clinical research activities comply with applicable local, national, and international regulations and guidelines, including but not limited to Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and applicable laws.
• Leads regular internal audit activities across all PREVAIL sites and work with the site and other authorities to identify and address compliance concerns.
• Assists investigators in understanding and carrying out their regulatory compliance and ethics responsibilities.
• Coordinates and facilitates audits of sponsors, as required. Addressing any findings and implementing corrective and preventive measures.
• Collaborates with the Learning and Professional Development (L&PD) department to provide training on regulatory compliance and ethical considerations to research staff and investigators, promoting a culture of awareness and adherence.
• Assists the data management team in resolving QA/QC issues across all the sites.
• Participates in study initiation and closure activities, ensuring compliance with all regulatory and ethical requirements.
• Identifies areas for process improvement in regulatory and ethical practices within PREVAIL and collaborate with the appropriate staff to implement changes.
Reporting
• Works with the study team to identify reportable events in accordance with the scientific and compliance requirements of the relevant ethics and regulatory authorities.
• Works with the study team to ensure the timely and accurate reporting of adverse events and safety-related information to the ethics and regulatory authorities and sponsors, as appropriate.
• Documents and reports all internal audit findings to the appropriate individuals.
Other duties as assigned.
Qualifications
 Education:
• Bachelor’s degree in a relevant field (such as Biomedical Sciences, Public Health, Bioethics and law, regulatory science, or other related fields.
• Master’s degree in regulatory science, bioethics and law, or health research ethics is an added advantage.
 Preferred Job-related Experience: At least three (3) 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:

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