CARE PrEP Clinical Research Assistant

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 the three study sites in Kisumu and Mombasa counties.

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.

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.

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