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Cra - all levels

Synvia
Anunciada dia 1 maio
Descrição

JoinSynvia To join our team, we are looking for professionals who want to contribute to our mission of improving lives of more and more people. If you have an innovative profile, think outside the box, and enjoy working in a modern and dynamic environment, this position is for you. Come join us on this journey. JoinSynvia Responsabilidades e atribuições We count on you to: CRA - all levels General On-Site Monitoring Responsibilities, including routine monitoring visits and close-out of clinical sites; Conduct pre-study visits such as SQV – Site Qualification Visit and SIV – Site Initiation Visits; Ensure the integrity of the data submitted on Case Report Forms (CRFs) by carefully reviewing source documents; Perform CRF review, including generating and resolving queries, to ensure data quality; Maintain study files, ensuring audit readiness at the site level; Prepare and provide FUP (Follow-Up) letters and reports within the established deadlines for respective monitoring visits; Track and follow up on Serious Adverse Event (SAE) reporting, including producing reports, narratives, and following up on SAEs; Track and follow up on Deviation Reports according to the study's plan; Act as the focal point of communication between the site team, project manager, and vendors to resolve any arising issues. Liaise with vendors and perform other duties as assigned; Ensure that the conduct of clinical trial activities complies with current ethical regulations, Good Clinical Practices, and protocol guidelines; Maintain accounting and control of investigational products and other trial materials/supplies; Travel, including air travel, will be required and is an essential function of the job. Prepare accurate and timely trip reports and expense reimbursements. Requisitos e qualificações What we are looking for: CRA - all levels Complete higher education in Pharmacy, Biomedicine, or Nursing; Good Practices in Clinical Research, Initiation Visit, Routine, Close Out, and center qualification; Intermediate English; Minimum of 2 years' experience in clinical research as a clinical research analyst, or previous experience as a research center coordinator. Availability for travel. Informações adicionais Work Unit: Administrative Headquarters: Paulínia/SP Monitoring Trips What benefits we offer you: Transportation allowance. Parking (subject to availability). Heath Insurance with no monthly cost to employee, with co-participation for exams and medical consultations. Dental plan with monthly co-participation. Life Insurance. Food/Meal allowance. Pharmacy benefit. Vaccination program. Synvia Partnership Club (Education Institutions, Language Learning, Leisure and Cultural Activities). Hybrid Work Model (to be aligned with leadership). SESC Partnsership; Physical health program - TotalPass. Heath Professional - Day off. Nursery assistance (as per internal policy). J-18808-Ljbffr

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