Reports: Global MEL Director
Location: Preferably Bangladesh, Burkina Faso, Burundi, Cote D’Ivoire, DRC, Egypt, Ethiopia, India, Jordan, Kenya, Mozambique, Nigeria, Niger, Pakistan, Tanzania, Togo, Uganda or United States.
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.
Other Information:
Please note that the position is a fixed term position for only 9 months and requires the person to work 20 hours per week
Technology to be Used:
- Uses cellular and office phone, laptop, or desktop computer.
Travel Requirements:
- Travel required (10% or less)
Application procedure / How to apply:
- Interested applicants are requested to include the contact details for at least 3 references in their resume.
- Please submit your application via pathfinder website no later than August 18th, 2023
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
Pathfinder International provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Safeguarding and Protection
Pathfinder is committed to the safeguarding and protection of the people we serve and our staff. We have zero tolerance for any type of behavior that inflicts harm on children, young people, adults, our staff, and partners including sexual abuse, harassment, bullying, and exploitation. We do everything possible to ensure that we recruit only those who are suitable to work with for us and expect that everyone we hire will abide by our safeguarding and related policies and will report any suspected or known violations. This job is subject to a range of vetting checks as legally permitted in the country where they are being hired. By applying, the job applicant acknowledges they understand our intent to verify suitability to work with us.