Regional Associate Research Officer 1689 views0 applications

Elizabeth Glaser Pediatric AIDS Foundation (EGPAF)

Job Description

TITLE:    Regional Associate Research Officer, Regulatory Affairs

LOCATION: Africa (based in any EGPAF Country program) **please note this position does not carry expatriate or relocation benefits and the selected candidate must be a citizen of one of the countries in the following locations:

• Cameroon – Yaounde
• Côte d’Ivoire – Abidjan
• Democratic Republic of Congo – Kinshasa
• Kenya – Nairobi
• Lesotho – Maseru
• Malawi – Lilongwe
• Mozambique – Maputo
• eSwantini – Mbabane
• Tanzania – Dar es Salaam
• Uganda – Kampala
• Zimbabwe – Harare

REPORTS TO: Research Officer, Regulatory Affairs (based in DC)

“Sometimes in life there is that moment when it’s possible to make a change for the better. This is one of those moments.”

-Elizabeth Glaser

The Elizabeth Glaser Pediatric AIDS Foundation is a global leader in the fight against pediatric HIV and AIDS, working in 19 countries and at close to 5,000 sites around the world to prevent the transmission of HIV to children, and to help those already infected. With a growing global staff of over 1,000—nine of 10 who work in the field—the Foundation’s global mission is to implement prevention, care, and treatment; further advance innovative research; and to execute strategic and targeted global advocacy activities  to bring dramatic change to the lives of millions of women, children, and families worldwide.  The Foundation is committed to the ethical conduct of all research and evaluations conducted by EGPAF personnel, the protection of human subjects in research, and compliance with all applicable regulatory requirements and ethical guidelines.  As such, the Foundation seeks an Associate Research Officer, Regulatory Affairs to support and monitor the conduct of research within EGPAF country programs.

Job Responsibilities

• Assist the Research Officer, Regulatory affairs with oversight of regulatory and protection of human subjects in research activities within Foundation supported and conducted clinical, laboratory, and operations research across Africa.
• Assist the Research Officer, Regulatory affairs with review of protocols, consent forms, and other required documents prior to IRB submissions.
• Provide capacity building and support to Foundation personnel involved in research and evaluations in the implementation and ethical conduct of high quality research and evaluations.
• Provide capacity building and support for the development and maintenance of accurate and up-to-date essential regulatory documents that will serve to demonstrate compliance with good clinical practice (GCP), regulatory, Foundation, and sponsor specific policies and procedures for international HIV, TB and related studies in women, children and adolescents, and families.
• Assist in the regulatory oversight of Foundation multi-center, multi-country studies.
• Provide periodic internal study monitoring of Foundation research and evaluations to ensure adherence to protocols and study related standard operating procedures (SOPs), IRB/regulatory review and approval requirements, and procedures to produce quality research data.
  • Provide quality assurance of all essential documents maintained by the local personnel on site (e.g. source documents in participant files, laboratory documentation, and participant consent forms).
  • This may be accomplished through periodic site visits for review of these documents, close communication by conference calls and email with onsite personnel, and facilitation of training of onsite personnel responsible for regulatory activities.
• Assist in development and/or review of country specific SOPsfor Foundation research activities; ensure that staff are trained on those SOPs as appropriate; coordinate and ensure review of applicable SOPs by staff on a timely basis.
• Assist country teams with development of clear processes for site communication with local IRBs, including coordination of activities between all IRBs involved in a given protocol, and documentation of IRB correspondence. Communicate regularly with site study personnel to ensure timely submission of annual renewals, study approvals, adverse event reports, and other correspondence.

Required Qualifications

• Registered nurse, BA/BS degree in nursing or other health-related field or extensive regulatory experience in lieu of degree.
• Minimum of 5 years of experience in clinical/operational research coordination and/or study monitoring.
• Experience with research in developing countries, particularly in Africa.
• In depth knowledge of Good Clinical Practices, ICH Guidelines, US federal regulations for protection of human subjects’ participation in research, OHRP/Federal Wide Assurances, and USAID/CDC research regulations.

Knowledge, Skills, and Abilities

• French and/or Portuguese language skills are an advantage.
• Must have excellent organizational skills, initiative,and be capable of functioning independently with minimal supervision.
• Excellent attention to detail and follow through.
• Knowledge of medical terminology and ability to follow multiple, detailed activities across a variety of protocols.
• Excellent interpersonal, oral, and written communication skills.
• Proven ability to work effectively as member of dynamic team in fast-paced environment
• Willingness and ability to travel within Africa, up to 30-40% time.
• Proficiency in computer software applications such as Word, Excel, and Power-point.

Competencies

The Foundation expects all employees to possess the fundamental competencies of interpersonal skills, communication, accountability, continual learning, and driving results. The ideal candidate will either be proficient or advanced in the following set of competencies, specific to this position’s level of Officer:

The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, EGPAF complies with applicable state and local laws governing nondiscrimination in employment in every location in which the Foundation has facilities.