Current Vacancies at FHI360 NGO

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

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Job Summary:

• Working under the general supervision of the Country Study Coordinator, the Clinical Research Assistant will be responsible for recruiting and consenting eligible study participants, conducting all study procedures with participants, tracking study participants over time, and following all study operations to ensure accurate data and ethical treatment of study participants. The position is 100% level of effort (LOE) ideally be based in either Kisumu or Mombasa County and based at one of the study sites with periodic in country travel. The ideal candidate will have an obstetric background with experience in clinical data collection.

Responsibilities:

• Participate in study training and adhere to the study protocol and all study procedures.
• Participate in the translation, testing and review of data collection tools.
• Identify, recruit and screen potential study participants.
• Coordinate with CATALYST study staff for referral of participants for the CARE PrEP study, and for any other needs to ensure smooth operations between the two studies.
• Conduct and document informed consent process; securely store all informed consent documents per study procedures.
• Conduct study visits with participants throughout pregnancy, postpartum and their infants through 6 months of life. Visits to occur at study sites with possible home visits and phone contacts.
• Visit procedures include ascertaining medical information from participants, review/interpretation of medical records, point of care HIV and urine pregnancy testing, blood pressure check, depression screening, infant feeding assessments, physical exams of infants to identify birth defects/congenital anomalies, and referring for medical care as needed.
• Upon learning of any serious adverse event or social harm, complete required forms and study management notification.
• Review health facility registers, and participant records and capture required information according to operational procedures.
• Document study visit information and data on paper-based and electronic forms as applicable and maintain all participant information in an organized and confidential manner.
• Provide and document participant reimbursement per study protocol.
• Manage study visit schedules to maintain high participant retention.
• Consult and communicate in a timely manner any challenges encountered during data collection and resolve queries with the Country Study Coordinator and US-based data management team.
• Implement quality control process throughout the conduct of the study.
• Participate in regular team meetings.
• Perform any other related duties.

Required Qualifications And Experience

• At least 3 years clinical experience in maternal and newborn health; obstetric experience preferred.
• At least 2 years of experience of data collection experience in a clinical research setting
• Experience engaging with adolescent girls, young women and pregnant people preferred.
• Must reside near a study site.

Skills Knowledge And Abilities

• Excellent communication skills
• Ability to navigate electronic data collection systems (experience with ODK, REDCap, KoboCollect, or SurveyCTO)
• 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

• Clinical degree or diploma (nursing or clinical officer) or related field from any recognized institution.
• Have a valid License to practice in Kenya.