Act as the sponsor's main contact person in all matters regarding specialty laboratory services, following up and responding to clinical study specific inquiries from Sponsors, Physicians, CRA and CRO representatives and Site Services Department.Review newly assigned protocols and Amendments. Prepare and QC clinical study specific materials.Ensure that proper guidelines for communication are set at study start-up and maintained throughout a study by creating and updating the study specific Communication and Escalation Plan. Maintain clinical study specific study files and ensure that all appropriate documents are properly maintained.Ensure that all necessary documents are archived at study closure.Provide Sponsors with study management reports. Monitor study budget.

Mantains an integral role in the execution of various clinical studies and responds to time-sensitive inquiries, concerns and facility calls as needed.Handles daily project-assigned tasks and correspondence with stakeholders. Host internal and external project meetings. Support Project Managers by creating, reviewing, and updating project documentation, status reports, user manuals and risk management plans.eCOA support of clinical trials from start-up to maintenance and close out phases. Project management for mid-size sponsors.Supply chain and logistics support.

Prepared study plans. Given biological scientific area courses directed to different degrees of speciality and knowledge (bioethics, clinical research, genetics and molecular biology). Integration of digital tools and teaching platforms.

Taken and processed biological samples for SARS-COV2 antigen detection.Support to clinical laboratory. Several biological specimens collection (blood, nasopharingeal swab, fungal and bacterial cultures, among others). Direct dealing with patients. Prepared inventories. Operations under international norms ISO 9001-2008 and ISO 15189-2012 and intern Quality Management System.

Processed biological samples for SARS-COV2 detection.Nucleic acids extraction and amplification by qRT-PCR by means of automated equipmentManagement of thermocyclers CFX & QIAquant 7500.Use of Lablyze software for results validation.Medical history integration through Cobas-infinity IT (Roche) Interface.

Development of research projects. Standarization and characterization of experimental models. Immunology, biochemical and molecular biology techniques. Pharmaceutical forms and diets design and manufacture. Laboratory animals handling.Work in preclinical and phase 1 clinical trials. Assist in preparing reports and data collection for statistic analysis. Wrote review articles. Active comunication with ethics committees.