Sobre

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. #JoinSynviaResponsabilidades e atribuiçõesWe 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.Lead CRA:Train, develop and assist Monitoring Team (CRA all levels) and Clinical Research Analysts.Identify and evaluate issues in the management of activities of research site, through monitor follow-up and propose resolutions and action plans for the team.Support the review of project-related plans, such as monitoring, deviation, risk plans and study specific documents.Perform revision of monitoring reports such as site qualification reports (SQV), initiation (SIV), regular monitoring (MoV) and close-out (CoV) reports, ensuring their quality and follow-up on outstanding items and issues.Perform sampling review of the eTMF to ensure its quality.Develop and support CRAs and analysts, seek process and tool optimization to form high-performance teams.Act as the main communication liaison between CRAs, Clinical Project Managers and Clinical Operations Managers.Ensure that clinical monitoring activities of the assigned team are conducted to sponsor satisfaction, ensuring quality results in a timely manner, within budget, and in accordance with standard operating procedures (SOPs), local regulations, good clinical practices (GCP), and study-specific requirements.Supervise the performance of monitors and analysts, as well as develop performance evaluation metrics and necessary training.May be required to provide on-site supervision for CRAs and/or conduct monitoring or co-monitoring (as needed).Oversee and maintain study-specific and corporate trackers.Supervise CRAs workload and propose adjustments and reallocations of human resources.Requisitos e qualificaçõesWhat 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.Lead CRA:Complete higher education: Pharmacy, Biomedicine, Nursing etc.At least 6 - 7 years of experience working as CRA - Clinical Research Associate.Behavioral skills: ethics, integrity, effective communication, teamwork, flexibility, leadership and well organization.Advanced English.Desirable Spanish.Availability for travel.Informações adicionaisWork Unit:Administrative Headquarters: Paulínia/SP - Home Based.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).