Key skills
GCPCommunication
About this role
Role Overview
- 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).