The Lead CRA coordinates all monitoring activities related to clinical and non-interventional studies. The Lead CRA is also responsible for coordinating country-specific activities in large multicountry studies. The Lead CRA is also responsible for the preparation of the study monitoring plan under the supervision of the Project Director/Senior Project Manager. The Lead CRA assures that the monitoring visits in multicountry studies will be conducted according to the monitoring plan and will review all monitoring reports according to the guidelines agreed with the Sponsor.
Furthermore, the Lead CRA supervises the filing of all study-related documentation in the Trial Master File as well as the documents provided by the Site (Investigator's file).
Supervision of site activation and site management including monitoring activities (from feasibility to close out) in accordance with relevant parts of GCP/GPP/GEP, SOPs, the study protocol, and study plan in national and international clinical trials / non-interventional studies.Training of CRAs / Clinical Trial Assistants (CTAs) on study-specific requirements.Development of project-specific training material for CRAs and study sites.Project-specific review of timelines and client's requirements regarding site management and monitoring activities; identification of critical issues at an early stage.Escalation Management, if required.Support of review of Standard Operating Procedures (SOPs) and engagement in process improvement initiatives.Contribution to or preparation of submissions and/or notifications to the Ethics Committees (EC) and, when applicable, to the Regulatory Authorities (RA).Development and review of the Monitoring / Quality Review Plan.Contribution to the initial set-up, ongoing maintenance, and final distribution of the Study/Trial Master File.Preparation of the Investigator Site File and coordination of its distribution and ongoing maintenance of the respective sections of the Study/Trial Master File.Coordination and review of monitoring reports and follow-up communication.Review and preparation of essential study documents e.g., Patient Information and Informed Consent Form.Monitoring of the CRA visit schedule.If required, conduct of any kind of monitoring visit/call.Coordination and (if required) performance of co-monitoring activities as applicable.Qualifications:
A minimum of 4 years of experience as CRA conducting monitoring, managing TMF, and initiating study sites for conducting clinical and/or non-interventional studies including Post-Authorization-Safety-Studies and degree educated. All employees must be legally authorized to work in the country where the position is located. Work visa sponsorship is not available for this position.
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