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SYNVIA logo
SYNVIA

La logistique fluide, maîtrisée et sécurisée.

Clinical Research Associate II/III - CRO

Conversion Rate OptimizerConversion Rate OptimizerFull TimeRemoteMid LevelTeam 51-200Since 1993H1B No SponsorCompany SiteLinkedIn

Location

Brazil

Posted

84 days ago

Salary

0

Seniority

Mid Level

Bachelor Degree3 yrs expPortugueseEnglish

Job Description

Clinical Research Associate II/III - CRO

SYNVIA

• 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.

Job 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).

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