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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