Ensuring and coordinating a policy-compliant study, conducted in accordance with protocol, SOPs, local policies and legislation as well as ICH-GCP guidelines, quality and time management
Appointed point-of-contact for the management team of the sponsor
Assistance in the selection and identification of suitable study sites
Organizing Investigator Meetings, Team Meetings and Study Workshops
Budget and contract negotiations with study sites and involved institutions, resident doctors, vendors, etc.
Obtaining necessary insurance cover including budgetary negotiations with insurance agencies
Preparation and implementation of study-specific training
Preparation of all study documents, such as protocol synopsis, monitoring plan, and patient informed consent
Qualitative verification of monitoring reports
Creation and monitoring of patient recruitment strategies and patient enrolment plans
Conducting co-visits at participating study sites for quality control and assurance
Assistance in the preparation and execution of sponsor audits and inspections, including preparation of audit and inspection reports (CAPAs)
