International AIDS Vaccine Initiative (IAVI) is hiring a
Clinical Operations Specialist or Senior Clinical Operational Specialist

The International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS. Key Responsibilities: Clinical Operations: Manage clinical vendors (including on-site monitors / CRO) and oversee relevant sections of the Protocol Management Plan. Responsibilities include, but are not limited to the following activities: Lead point of contact for clinical vendors, Support vendor selection and contracting, Train vendors, Monitor vendor performance against contract, ICH GCP, relevant SOPs, local Regulatory and ethical standards and protocol; includes site visit report review and quality oversight visits. Track vendor invoices for accuracy and against contract and send invoices for processing and payment. Provide initial and ongoing training to other departments and site staff to support the conduct of clinical trial activities. Conduct risk planning and mitigation for vendors and clinical activities working with CTMs (Clinical Trial Managers) to mitigate risks and solve issues. Review, provide input, and draft assigned sections of key study documents. Ensure approved monitoring plan is in place. Develop quality oversight plan for monitoring activities. Assist CTM in establishing study timelines and budgets for clinical aspects of trials and ensure clinical activities are conducted within timelines and budget. Manage and oversee the completeness and accuracy of the Trial Master File (TMF) through appropriate reviews of all study related information, while ensuring TMF is inspection ready. Work with CTM and other departments to oversee data quality through various means including data listings reviews. Prepare for and conduct site visits as needed, including site qualification, study initiation and Quality Oversite visits. Provide study status updates to project team and management as needed. Act as clinical operational lead on observational studies as assigned. Oversee studies that IAVI monitors for other sponsors. Departmental and knowledge development activities: Participate in/initiate Clinical Development departmental activities as assigned (e.g., drafting/reviewing operational procedures, participating in departmental meetings, etc.) Provide support and back-up to senior departmental personnel as needed, such as attending meetings, assuming lead in study team meetings or ad-hoc meetings, generating and/or reviewing minutes, and following up on action items. Remain up to date on knowledge of clinical trial methodology, ICH GCP, FDA regulations, EMA Regulations, and other local/international regulatory and ethical guidelines and requirements. Remain abreast of scientific knowledge of targeted disease and population and investigational product(s). Participate in training activities for new staff, as needed. Perform other duties as assigned.