FHI 360

Job Description

Job Title: CARE PrEP Country Study Coordinator (SC) - Kenya

Reports To: Regional Senior Technical Advisor

Location: Operate alongside CATALYST in three study sites in Kisumu and Mombasa

Project 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 three study sites in Kisumu and Mombasa.

Job Summary:

The CARE PrEP Country Study Coordinator (SC) is responsible for coordinating all study activities in Kenya 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 2-3 Clinical Research Assistants based at study sites, liaising with in-country CATALYST staff and local stakeholders engaged in the study, and ensuring smooth operations at all study sites. The position is full-time, based in Kisumu County and requires periodic regional travel to study sites for supervision and international travel for study-wide coordination. The ideal candidate will have experience in clinical research coordination and basic data management.

Responsibilities:

• 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) across all sites.
• 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 regularly between study sites to perform study operational and oversight duties.
• Travel for regional protocol meetings as needed.
• Perform any other duties related to the study.

Required Qualifications and Experience

• Must have at least 5 years’ experience in research coordination
• Experience with clinical research.
• 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
• Clinical background preferred but not required.

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.
• Nonjudgmental attitude, humanitarian values and ethics are absolute preconditions.
• Energetic, independent and self-motivated
• Good knowledge of spoken and written English and Kiswahili

Education requirements

• Bachelor’s degree or international equivalent in Social / Behavioral / or Life Sciences, Health Sciences, Information Management or Related Field
• Master’s preferred

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.

Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.

FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.

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