Clinical Research Associate at University of Nairobi
- Nairobi
- Permanent
- Full-time
- Champion participant safety and wellbeing, rights and confidentiality
- Ensure appropriate GCP and HSP training, certification and practice for all study personnel
- Participate in study design and planning including pre-study assessment for study sites, development of study materials, compilation of the investigator site file, and pre-study trainings
- Work with the study team to oversee ERC and regulatory submissions, responses, renewals, amendments, notifications and communications
- Ensure appropriate training of study personnel on the study, including protocol, refresher and remedial trainings
- Oversee the informed consenting process
- Assist the Study Coordinator in the maintenance of investigator site files
- Develop monitoring plan for all supported studies
- Conduct site monitoring visits as per the monitoring plan including oversight of independent monitors.
- Regularly review study data including conducting source data verification, raise data queries, and review resolution of queries to ensure integrity of study data.
- Prepare sites and participate in sponsor, ERC and regulatory audits
- Work with study sites to address monitoring and audit findings
- Oversee study close-out including ensuring appropriate disposal of investigational products, archiving of study documents, and closure of study sites as needed
- Any other duties assigned by the supervisor
- Bachelor degree in a health-related field
- Registered healthcare practitioner with a valid practice certificate
- MUST have a current Certificate of Good Clinical Practice
- MUST have a current certificate in Human Subject Protection
- Certificate in clinical trial monitoring
- Previous experience working as the main Study Monitor for at least two large clinical trials
- Previous experience supporting regulatory compliance for multiple clinical trials
- Experience with a multi-country clinical trial is an added advantage
- Good communication skills
- Willing to travel extensively and on short notice
Jobs in Kenya