Study Coordinator at Zambia Emory HIV Research Project

• Responsible for all elements of the administration and oversight of ZEHRP research protocols.
• Coordinate and submit to ethics/regulatory study protocols and amendments, informed consent, progress reports, annual renewals and organization of investigator site files
• Maintain investigator site files
• Understand local and international standards (e.g., UNZAREC, ZAMRA, NHRA, NBA and GCP)
• Communicate with departments, across RZHRG sites, with sponsor and regulatory/ethics authorities
• Report safety events to regulatory/ethics
• Report protocol deviations/reportable incidents to regulatory/ethics
• Coordinate activities related to study recruitment and retention
• Perform quality control of informed consents including assessment of understanding
• Prevent co-enrollment prevention and identify participants at subsequent visits
• File and organize of informed consents and related documentations
• Ensure study team are trained per their study roles as it relates to GCP, GCLP, human subjects, study protocol, standard operating and study specific procedures
• Coordinate SOP creation and revision with department managers
• Ensure corrective actions and preventative actions have been implemented and monitored for deviations planned and unplanned
• Coordinate and submit progress reports to sponsors
• Ensure emergency trolley, emergency equipment and clinic equipment such as scales, thermometers, blood pressures machines are calibrated
• Perform quality control of study data
• Ensure data is entered within expected turnaround time
• Resolve data queries within expected turnaround time
• Review trends for site performance metrics
• Ensure site’s adherence to quality management plan
• Ensure site has adequate supplies to execute a study
• Coordinate day to day activities between clinic, lab, data and pharmacy
• Coordinate monthly/quarterly budget with clinic team
• Coordinate with the study team on a rotational on-call scheduled. On-call requires accessibility to study patients, physician investigators and research staff during non-office hours.
• On-call duties as needed

Qualifications required:

• At least a Bachelors in a health related field
• Licensed medical professional preferred (nurse or clinical officer)
• Good Clinical Practice and Human Subjects Education
• Clinical trials experience (preferred)
• Experience using MS Windows and MS Office packages (Excel, Word, PowerPoint, etc)
• Ability to work both independently and in a team

Personal Skills

• Pleasant, outgoing, and mature
• Excellent oral and written English skills required
• Highly organized with excellent time management skills
• Attention to detail
• Self-discipline, Diligence and persistence

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