**LOCATION: NAIROBI AND UGANDA (3 POSITIONS)
• Assist with site selection activities, including site qualification visits.
• Serve as first line of contact for study sites.
• Assist with preparation of documents for regulatory and IRB submissions as required.
• Perform site initiation visits and other site trainings as needed.
• Assist with the development of study-specific, risk-based monitoring plan, study operations manual, tracking forms, and other study related documents as required.
• In keeping with best practices of Risk Based Monitoring, conduct on-site and remote monitoring to review clinical data for accuracy, completeness and discrepancy resolution.
• Submit monitoring visit reports and monitoring visit follow-up letters within required timelines.
• Assure study site adherence to the protocol, GCP, procedural documents and recommend necessary actions to bring about compliance or improve processes.
• Anticipate/identify potential problems, implement corrective and preventive actions and escalate where appropriate.
• Assist with vaccine supply management and ensure proper storage, dispensation, and accountability of all investigational product(s) and trial-related material at study sites.
• Receive and review weekly enrollment updates during site/study enrollment period; update team.
• Liaise with sites and IAVI data management or other departments, as requested, to resolve data queries.
• Maintain good relations with IAVI collaborators and trial sites to facilitate site development and execution of clinical trials.
• Participate in teleconferences, Investigator Meetings, GCP trainings, Study Close-Out visits and additional visits to sites as needed.
• Coordinate with the IAVI Team and sites to ensure proper and timely submissions to IRBs, review and assist in preparation of appropriate responses for re-submission if necessary. Ensure IAVI reviews and approves all documents prior to submission and implementation at the site. Receive/obtain copies of all IRB submissions.
• Ensure proper reporting, follow-up internally and assist in management of Adverse Events (AEs)/Serious Adverse Events (SAEs) per protocol. Ensure SAEs, safety update reports and other new information or sponsor reports are provided to and received by the sites for reporting to ethics, as needed.
• Ensure all Serious Adverse Events (SAE) reports are reviewed, signed off by the responsible physician and filed within required timelines
• Create and maintain Trial Master Files in compliance with ICH guidelines
• Contribute to Clinical Development Standard Operating Procedures for conduct of clinical trials based on IAVI templates and ensures adherence to regulations/guidelines for GCP.
• Other duties as assigned.
EDUCATION AND WORK EXPERIENCE:
• Bachelor’s degree required, BS in scientific field, nursing degree or advanced degree in relevant field preferred
• Minimum 2 years relevant experience, including at least one year as a Clinical Research Associate, performing monitoring of clinical trials. 2+ years clinical monitoring experience preferred.
• Experience with clinical research data, investigational product, or maintenance of investigator sitefiles.
• Experience with HIV or vaccine research preferred.
OTHER KNOWLEDGE, SKILLS, AND ABILITIES:
• Computer literate
• Critical thinker
• Attention to detail
• Excellent verbal and written communication
• Strong organizational skills
• Able to take responsibility for completion of tasks with high quality according to established program timelines
• Identify problems and possible solutions and assess the impact on timelines
• Adept at electronic data capture (EDC) systems, electronic Trial Master Files, electronic Quality Management Systems
• Expert knowledge of Good Clinical Practices (GCP) and Good Documentation Practices
• Proficient in Microsoft Outlook, Word, Excel, PowerPoint
• Proficient in QA/QC systems and practices
• Knowledge of HIV and/or global health is preferred
• Willingness to travel (up to 50%)
Method of Application
Interested and qualified? Go to International AIDS Vaccine Initiative (IAVI) career website by clicking the Apply Now Button.
The Clinical Research Associate (CRA) is responsible for performing both onsite and remote monitoring of clinical sites to ensure compliance with the protocol, ICH GCP, applicable regulations and institutional SOPs. The CRA acts as the site’s primary contact with the trial sponsor.
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