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