Research Quality Assurance and Regulatory Officer

Location: Lilongwe, Malawi
Job Code: 1747
# of openings: 1


The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) is the global leader in the fight against pediatric HIV/AIDS and has reached more than 26 million women with services to prevent transmission of HIV to their babies. in 2015-2016, EGPAF supported activities in 19 countries and nearly 5,000 sites to implement prevention, care, and treatment services; to further advance innovative research; and to execute global advocacy activities that bring dramatic change to the lives of millions of women, children and families worldwide.

EGPAF has worked in Malawi since 2001. Today, EGPAF Malawi implements evidence‐based HIV prevention, care and treatment interventions in 179 health facilities in nine districts through EGPAF’s U.S. President’s Emergency Plan for AIDS Relief/U.S. Centres for Disease Control and Prevention (PEPFAR/CDC) ‐funded HIV Service Delivery, Quality Improvement and Health Systems Strengthening Program. EGPAF seeks to fill the following open position:

Position Details

Job title               : Research Quality Assurance & Regulatory Officer 

Location              : Lilongwe

Reports to           : Public Health Evaluations and Research - Senior Manager (PHER - SM)


Job Summary                        

The Research Quality Assurance & Regulatory Officer (QA&RO) will be responsible for internal monitoring, quality control and quality assurance of Research and Evaluation studies, including development of monitoring tools, conducting audit, writing monitoring reports and feedback of findings to the study team for quality improvement. The QA&RO will work with the study team to oversee development and implementation of Corrective Actions and Preventive Action (CAPA) Plans.

Essential Responsibilities

  • Develop electronic and paper tools for internal study monitoring, quality control and assurance procedures and audits

  • Oversee regular monitoring of study documentation including regulatory files at the EGPAF Malawi Research and Evaluation Implementation sites

  • Oversee regular monitoring to ensure adherence to good clinical practice, including appropriate screening and consent of participants, and recruitment of eligible participants

  • Oversee regular monitoring to ensure adherence to study standard operating procures for participant assessments and follow-up, data collection, lab procedures and other relevant study procedures

  • Working with the data team, facilitate resolution of data queries

  • Conduct regular audits to assess specific aspects of study implementation, and variables critical to responding to study end-points

  • Write regular monitoring and audit reports, and share findings with the study team and investigators 

  • Work with the Study Coordinators to develop and implement Corrective Action and Preventive Action (CAPA) plans

  • Other duties as assigned

Required Qualification, Experience and Skills

  • Candidate must hold a degree or professional equivalent, preferably in a health-related discipline. Post-graduate training will be an advantage. 

  • 3 or more years of experience in operational or clinical research related involving human subjects

  • At least 1 years’ experience in conducting quality assurance procedures or study monitoring with demonstrated knowledge and skills in this area

  • Must be attentive to detail and conscientious about timeliness of activities and deadlines

  • Knowledge and certification in good clinical practice

  • Strong problem-solving skills and analytical capabilities

  • Willingness to spend substantial time at the site.

  • Proficient in Microsoft Office Suite applications.

  • Excellent interpersonal, organizational, verbal and written communication skills.

  • Flexible and adaptable and able to multi-task effectively.

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