Posted on Mar 15, 2019 by Clintec
To implement clinical trials (phases I/II/III in oncology) on logistical and operational aspects in accordance with the regulations and good clinical practices to coordinate functionally the CRA activity on the projects
the feasibility, the selection of sites and the collection of the essential documents. Perform a critical proofreading of the study documents and participate in the drafting of the technical documents of the study (supporting documents, implementation slides...).
Participate in the preparation of regulatory submission files in relation to the assistant and the regulatory team ensure the initiation of the study on the administrative, technical, logistical, and clinical aspects as well as the organization of Meetings with the investigators.
Follow the implementation of the monitoring according to the plan established and reread the reports of visits within the time required.
Identify the risks, trace the alerts to the project manager and manage with him the implementation of adapted action plans validated by the project manager and/or the program manager.
To ensure the follow-up by the CRAs of the project team of adverse events in relation to pharmacovigilance.
Carry out the quality control of the study (2 x year) and report to the project manager.
Control the updating of the CTMS and the classification of the documentation in the TMF by the team ARC.
Support the CRA in identifying and monitoring actions Realize the need for co-monitoring. Ensure logistics (documents, biological samples, central laboratories, equipment, miscellaneous equipment, processing units) participate in the development of indicators and dashboards and inform them.
Participate in the development of CRF
Participate in the Data validation plan (review and coherence)
Participate in CRA recruitment develop and maintain contacts schools for recruitment of trainees in connection with CRA manager
Company Information: Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology. Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.