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SYNVIA

La logistique fluide, maîtrisée et sécurisée.

Clinical Research Associate I – II

Research AnalystResearch AnalystFull TimeRemoteMid LevelTeam 51-200Since 1993H1B No SponsorCompany SiteLinkedIn

Location

Brazil

Posted

59 days ago

Salary

0

Seniority

Mid Level

Bachelor DegreePortugueseEnglishGoogle Cloud Platform

Job Description

Clinical Research Associate I – II

SYNVIA

• Conduct monitoring visits (Site Qualification Visit – SQV, Site Initiation Visit – SIV, Interim Monitoring Visit – IMV, and Close-Out Visit – COV) according to the monitoring plan. • Perform on-site and/or remote monitoring, ensuring the study is conducted in compliance with the protocol, ICH-GCP, SOPs and local regulations. • Verify source data (SDV/SDR) and ensure the quality, integrity and traceability of clinical data. • Identify protocol deviations, inconsistencies and operational risks, supporting the implementation of corrective and preventive actions (CAPA). • Participate in clinical studies including bioequivalence, pharmacokinetics (PK), pharmacodynamics (PD) and Phase 1 studies, paying attention to the operational particularities of these designs. • Ensure sites are appropriately trained on the protocol, study procedures and systems used (eCRF, IWRS, eTMF). • Review and follow up on eCRF completion, and support query resolution with sites. • Ensure proper management of the Investigational Product (IP), including storage, dispensing, accountability and reconciliation. • Maintain the TMF/ISF up to date, ensuring document completeness and compliance. • Develop and maintain a professional relationship with investigators and site staff. • Proactively communicate study status, risks and issues to the Project Manager and other stakeholders. • Prepare monitoring reports and associated documentation within expected deadlines and quality standards. • Support start-up processes (when applicable), including collection of regulatory documents and site feasibility. • Provide support during audits and regulatory inspections.

Job Requirements

  • Bachelor’s degree in a health-related field (Pharmacy, Biomedicine, Nursing or related areas);
  • Knowledge of ICH-GCP and applicable regulations;
  • Initial experience or practical knowledge in clinical monitoring (on-site or remote);
  • Familiarity with clinical systems (eCRF, CTMS, eTMF) is a plus;
  • Exposure to bioequivalence, PK/PD or Phase 1 studies is desirable;
  • Intermediate English (reading and writing; conversational skills desirable).

Benefits

  • Transportation allowance;
  • Parking (subject to availability);
  • Health plan with no monthly premium for the employee, with cost-sharing for exams and consultations;
  • Dental plan with employee co-payment for the monthly fee;
  • Life insurance at no cost to the employee;
  • Flexible meal/food allowance;
  • Pharmacy discount program;
  • Synvia Partnership Club (education institutions, language schools, leisure and culture);
  • SESC partnership;
  • Physical health program - TotalPass;
  • Day Off – Health Professional;
  • Childcare assistance (according to internal policy).

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