Human Protections Administrator at Pathfinder International

Summary of Role:

• Serves as Pathfinder’s Human Protections Administrator (HPA) under Pathfinder’s Federal-wide Assurance (FWA) and has primary responsibility for Pathfinder’s Human Subjects Research (HSR) compliance program.
• The HPA will lead the development and enhancement of HSR policies and procedures in addition to related training and monitoring of HSR activities.
• The Human Protections Administrator will serve as Pathfinder’s internal expert on HSR related regulations and their application to research activities at Pathfinder.
• The HPA will be Pathfinder’s primary point of contact with Pathfinder’s external Institutional Review Boards (IRB) and oversee the vetting and engagement of external IRBs.

Key Responsibilities:

HSR policies and procedures:

• Provide guidance regarding the interpretation of HSR regulations and policies to Pathfinder researchers, global and country staff members, and senior management.
• Support in the development and implementation of organizational HSR policies and procedures.
• Develop and implement HSR Standard Operating Procedures (SOPs)

HSR compliance monitoring:

• Develop and implement HSR compliance and documentation system, including the creation of an online repository to safely store and organize regulatory documents, research related IRB documents, etc.
• In collaboration with the Pathfinder Legal and Audit Departments, conduct quality assurance monitoring of HSR, including investigation of matters of non-compliance.

HSR training:

• Design and implement HSR training program.
• Ensure compliance and documentation of HSR training by investigators, key personnel, and relevant Pathfinder staff members

HSR knowledge transfer:

• Coach, mentor, and train designated staff on the duties of an HPA and on the details of HSR policies and procedures.

Research protocols:

• Coordinates the technical and administrative review of HSR application materials prior to submission to the IRB.
• Coordinates the review and processing of ongoing research, protocol amendments/modifications, and reporting of adverse events.

Federal-Wide Assurance (FWA) compliance:

• Maintain current knowledge of HSR program guidance and regulations as they evolve.
• Assures any FWA or other assurances are maintained and updated in a timely way (i.e*.* prior to expiration).

Required Education and Work Experience:

• Bachelor's degree in Public Health, Biomedical Science, Nursing or closely related field.
• At least 3 years of experience directly related to the duties and responsibilities specified.
• Certification as Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), or Certified IRB Professional (CIP)
• Detailed knowledge and experience understanding and applying the U.S. “Common Rule” regulations and related OHRP/DHHS procedures, guidelines, and best practices for human subjects’ research.
• Knowledge of the mandates, operations, and organization of an IRB.
• Knowledge and understanding of HSR determinations and exemptions

Preferred Competence and Work Experience:

• At least 1 year working experience working with non-profits in the field of global health and development.
• At least 1 year working experience working with IRBs and Ethics Committees and advising on HSR and exempt HSR determinations.
• Experience supporting the implementation of human subjects’ research conducted in low- and middle-income countries.
• Experience applying the Common Rule to non-biomedical studies (social, behavioral, and educational studies).
• Software Applications: Advanced knowledge of MS Excel, PowerPoint, Word and Outlook.
• Project Planning and Management: Advanced knowledge and skills in project management and planning to fulfill performance objectives.
• Languages: Proven writing and speaking skills using English language required.
• Communication and Influencing Skills: Proven ability to influence others, including donor agencies and local partners, through diplomacy and proven oral and written communication skills.
• Presentation Skills: Proven ability to make presentations from prepared materials to small and large groups.
• Community Relations: Advanced skills in facilitating working relationships with key constituents.