SYNVIA

Clinical Research Associate II/III - CRO

SYNVIA

full-time

Posted on:

Location Type: Remote

Location: Brazil

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About the role

  • Act as a technical reference on the project, supporting the planning and execution of monitoring strategies.
  • Conduct monitoring of high-complexity sites, high-recruiting sites, or sites with a history of critical deviations.
  • Perform in-depth site performance assessments and support the implementation of corrective and preventive actions.
  • Collaborate with the Project Manager to define, review, and follow up on the monitoring plan.
  • Review monitoring reports from less experienced CRAs, ensuring standardization and quality.
  • Prepare sites for audits and regulatory inspections (ANVISA, FDA, EMA), providing technical guidance.
  • Identify operational risks and propose mitigation strategies to ensure adherence to timelines, data quality, and participant safety.
  • Lead technical training sessions, initiation visits, and internal training activities for new CRAs.
  • Support complementary study activities, such as eTMF review, regulatory support, and alignment with the sponsor on operational deliverables.
  • Maintain senior-level communication with internal and external stakeholders, representing the monitoring function when required.

Requirements

  • Bachelor's degree in a health-related field.
  • Advanced English.
  • Deep knowledge of Good Clinical Practice (GCP), Brazilian and international regulations, and experience conducting and supporting audits.
  • Minimum of 3 years of experience as a CRA, preferably with a background in multicenter and international studies.
  • Proven ability to serve as a technical reference and lead strategic study activities.
  • Strong experience with eClinical systems (EDC, CTMS, eTMF).
Benefits
  • Transportation voucher;
  • Parking (subject to availability);
  • Health insurance plan with no monthly premium for the employee, with co-pay for tests and consultations;
  • Dental plan with employee co-pay;
  • Life insurance at no cost to the employee;
  • Flexible meal/food allowance;
  • Pharmacy discount program;
  • Synvia Partnership Club (education, language, leisure, and cultural institutions);
  • Partnership with SESC;
  • Physical wellness program - TotalPass;
  • Day off — Health Professional;
  • Childcare assistance (subject to internal policy).
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
monitoring strategiessite performance assessmentscorrective actionspreventive actionsaudit preparationregulatory inspectionsoperational risk identificationmitigation strategiestechnical trainingeClinical systems
Soft Skills
collaborationcommunicationleadershipquality assuranceproblem-solvingstakeholder managementtrainingstrategic planningattention to detailadaptability
Certifications
Bachelor's degree in health-related fieldGood Clinical Practice (GCP) certification