CRA/ Sr. CRA

- Responsible for all aspects of site management and monitoring of clinical trials - Manage interactions with all partners (investigators, site teams, internal company departments, external contractors, etc.) to facilitate successful conduct of clinical projects. - Support clinical research activities as assigned by the supervisor. - Build strong professional relationships with investigators, site staffs and internal/ external service providers. - Conduct initiation visits, monitoring visits and site closure visits in collaboration with the clinical project team. - Maintain the Trial Master File. - Prepare and negotiate site clinical trial agreements and manage clinical site budget and expenses. - Preparation of regulatory and ethics submission dossiers. - Ensure protocol-related safety reporting compliance and address and drive issue resolution. - Monitor site recruitment and establish/discuss action plans in close collaboration with the Clinical Project Manager. - Develop and conduct training for investigators and site staffs in the protocol, product and study-specific procedures. - Coordinate activities to ensure compliance with protocol, GCP, overall clinical objectives as well as company policies and SOP. - Manage trial product inventory, shipment and storage, and ensure accountability and traceability. - Ensure that imaging and/ or laboratory samples are collected, handled and shipped according to protocol requirements. - Ensure that safety reporting of adverse events is completed within required time periods. - Manage external vendor services for assigned clinical sites. - Identify issues which affect clinical trial progress and quality, and develop solutions and/ or take action to resolve/ prevent them. - Deliver projects according to expected targets, budgets and quality standards. - Monitor and report to clinical management teams on clinical trial progress, performance and plan, including subject recruitment and retention, monitoring activities, data completeness and quality, and site compliance. - Assist in the organization and conduct of internal and external stakeholder meetings, as required. - Set up, maintain and update clinical research activities and initiatives in the system.