MATRIX-007/CARE PrEP Country Study Coordinator

negotiable / YEAR Expired 4 weeks ago
This job has expired.


MATRIX-007/CARE PrEP Country Study Coordinator

FHI 360 is a non-profit human development organization dedicated to advancing equity, health and wellbeing through data-driven, locally led solutions — so that humanity thrives. Our staff includes experts in Health, Education, Nutrition, Environment, Economic Development, Civil Society, Gender, Youth, Research and Technology; creating a unique mix of capabilities to address today’s interrelated development challenges. FHI 360 serves more than 60 countries, all 50 U.S. states and all U.S. territories.

Study Description:

CARE PrEP (MATRIX-007: Safety Evaluation following Exposure to Cabotegravir-, Dapivirine- and Tenofovir-based PrEP during Pregnancy) is a multi-country research study observing pregnancy outcomes for people that used “pre-exposure prophylaxis”, known as PrEP, during their pregnancy and their infants. Pregnant participants will be recruited from the CATALYST (Catalyzing access to new prevention products to stop HIV) study, which is a study seeking to understand the feasibility and acceptability of providing new options for HIV prevention. CATALYST involves introducing two new PrEP products for HIV prevention (PrEP ring and CAB PrEP) into existing health services. The CARE PrEP study will operate alongside CATALYST, in Lesotho.

The CARE PrEP Country Study Coordinator (SC) is responsible for coordinating all study activities in Lesotho and working with the Country PI and site teams to ensure adherence to protocol and procedures and effective operations across all study sites. This position involves supervising a team of 1-3 Clinical Research Assistants based at the study site, liaising with in-country CATALYST staff and local stakeholders engaged in the study, and ensuring smooth operations at all study sites. This is a full-time position which will be based in Maseru, Lesotho and work out of the study site and FHI 360 office and will involve international travel for study-wide coordination. The ideal candidate will have experience in clinical research coordination and basic data management.

Position Description:

  • Develop/review and monitor country/site-specific operating procedures, including for data collection and quality control, in line with the study protocol
  • Participate in development and review of study materials, including informed consent forms and data collection forms, to ensure appropriate contextualization and accurate translation local languages
  • Database testing to verify that error checks and programming is correct.
  • Co-organize and participate in study-related training; coordinate and lead refresher trainings or training of new staff throughout study period.
  • Coordinate with and manage all submissions to local IRBs, including amendments and protocol violations; liaise with US-based CARE PrEP Clinical Research Manager (CRM) on US-based IRB needs.
  • Obtain all necessary local approvals to conduct the study, including informing facility management of participating CATALYST sites and, as applicable, local leaders about the study and ensuring smooth operations between the CATALYST and CARE PrEP study
  • Oversee the recruitment, training and supervision of data collectors on site, including planning logistics for successful study implementation
  • Monitor study progress (recruitment and retention of study participants; form completion; data quality)
  • Manage study data collection equipment, including the loading, updating, testing, and troubleshooting of electronic data collection forms; assigning equipment to data collection staff.
  • Ensure that data management plans and equipment used for the study adhere to all local and contractual regulations (e.g. national data privacy regulations, data sharing agreements, equipment purchased is U.S government compliant
  • Ensure identification of and complete and accurate reporting of SAEs, social harms and protocol deviations or violations according to IRB and protocol-specific requirements
  • Provide advisement to research assistants on good clinical research practices and be able to perform study procedures, as needed and delegated based on clinical experience.
  • Work with sites to resolve problems; escalate to the Country PI and CARE PrEP CRM as appropriate
  • Complete field reports for the CARE PrEP CRM on a regular basis and liaise with the CRM through email and meetings as requested to report on study progress and coordinate study operations.
  • Work closely with the US-based data management team to ensure completeness and quality of data, including follow-up of data queries and discrepancies.
  • Participate as needed in data analysis conversations.
  • Travel for regional protocol meetings as needed
  • Perform any other duties related to the study.

Required Qualifications and Experience

  • Clinical degree in nursing, medicine or related field from any recognized institution. Master’s degree is an added advantage
  • Must have at least 5 years’ experience in clinical research coordination
  • Clinical experience working in maternity and MCH departments
  • Experience with data collection in REDCAP or similar database system; data management experience preferred
  • Experience supervising research implemented using electronic data collection platform preferred
  • At least 4 years of supervision/mentoring experience

Skills knowledge and abilities

  • Program coordination and management skills
  • Excellent communication skills
  • Knowledge of data management concepts, procedures and processes
  • Computer competency including proficiency in Microsoft Word, Excel and Powerpoint.
  • Ability to effectively manage and work as part of a team.
  • Non-judgmental attitude, humanitarian values and ethics are absolute preconditions
  • Energetic, independent and self-motivated
  • Good knowledge of spoken and written English and Sesotho
  • Preference is for Lesotho nationals

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

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Maseru, Lesotho
This job has expired.