Clinical Research Associate At University Of Nairobi

Job Description
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

Job Specifications
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