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hace 2 meses
Mabxience is seeking a highly skilled Clinical Study Coordinator to join our team. As a key member of our clinical operations department, you will be responsible for ensuring the successful execution of clinical trials.
Key Responsibilities- Manage clinical trial plans, communicating any deviations to the Medical Director and participating in the development of contingency plans and corrective measures.
- Participate in the selection of Contract Research Organizations (CROs) and external vendors, ensuring the execution of all contracted activities in accordance with plans (cost, quality, and time).
- Collaborate with potential partners and the Medical Director to identify centers and researchers involved in the study, and establish criteria for ensuring the performance of the trial in each center.
- Review and obtain approvals for necessary documentation from Ethics Committees and Health Authorities.
- Create and maintain updated monitoring plans, reviewing and approving all materials and guidelines required for the clinical trial.
- Supervise the control of blood samples for pharmacokinetic and/or pharmacodynamics studies, ensuring timely shipment and storage in the central laboratory.
- Inform researchers on relevant aspects of clinical trials and ensure their continuous updating.
- Supervise the quality of participating centers, participating in the formation of Independent Committees (IDMC, IRC, etc.) and coordinating their activities.
- Coordinate initial visits to centers, elaborate amendment documents to clinical trial protocols, and ensure approval of these amendments.
- Education: Degree in Health Sciences, Master's degree a plus.
- Languages: Fluent Spanish and English, knowledge of other languages an asset.
- Experience: +4 years of experience in a similar position, with international clinical trials experience.
- Specific Knowledge: Knowledge of applicable law in international clinical trials.
- Personal Skills: Strong organizational and prioritization skills, detail-oriented, ability to perform database/literature searches, excellent interpersonal skills, and effective communication skills.
