Senior Clinical Research Monitor

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Perform on-site or remote qualification/selection, initiation, monitoring, and close-out visits at research sites for training purposes as needed.

• Conduct visits during high demand periods as necessary.

• Mentor and provide guidance to junior and mid-level monitors during monitoring activities.

• Ensure that studies adhere to the protocol, ICH-GCP, relevant regulations, and internal procedures.

• Validate the quality, integrity, and traceability of clinical data in CRFs/eCRFs.

• Assist in developing the Monitoring Plan, Recruitment Plan, and other operational tools.

• Engage in meetings with research sites and multidisciplinary teams.

• Act as a technical resource for the monitoring team.

• Facilitate training and development sessions.

• Aid in the onboarding process for new Clinical Operations employees.

• Provide technical support for monitoring coordination.

• Serve as the primary liaison between research sites, monitors, and Clinical Operations coordination.

• Evaluate site performance and suitability, identifying risks and suggesting corrective and preventive actions.

• Assist with participant recruitment, retention, and engagement strategies.

• Conduct technical reviews of monitoring reports, follow-ups, and site letters.

• Ensure that the Investigator Site File (ISF) is current and compliant.

• Monitor protocol deviations, adverse events, and nonconformities, identifying trends and following up on action plans.

• Participate in audits and inspections as required.

• Contribute to the development of SOPs, work instructions, and Quality Management System documents.

• Ensure that study timelines and targets are achieved.

• Assist in the development and monitoring of site and CRA team KPIs.

• Identify opportunities for continuous improvement.

• Lead meetings with internal teams, sites, vendors, and stakeholders.

• Escalate risks and critical issues to management.

• Take part in the review of clinical protocols, informed consent forms (ICFs), eCRFs, operational plans, and study materials.

⛳️ Requirements

• Bachelor’s degree in a health sciences or biological sciences discipline, such as Pharmacy, Biomedicine, Physiotherapy, or Nursing.

• Intermediate proficiency in English (reading and writing).

• Demonstrated experience as a CRA, with a solid understanding of GCP and both national and international regulations.

• Familiarity with the ethics submission process (CEP/CONEP).

• Knowledge of clinical protocols, CRFs (Case Report Forms), and monitoring procedures (initiation, monitoring, and close-out visits).

• Experience with eCRF and EDC systems, such as Medidata Rave, Oracle InForm, and Veeva Vault.

• Specialization in Clinical Research is preferred.

• Master’s or doctoral degree is preferred.

• Previous experience at CROs and/or as a technical point of contact or CRA coordination lead is preferred.

• Familiarity with Se Suite, Veeva eTMF / CTMS is preferred.

• Willingness to travel (50% of the time for training, when necessary, and during peak demand periods).

🏝️ Benefits

• Meal allowance.

• Food allowance.

• 100% coverage for Libbs medications.

• Pharmacy benefit – Vidalink.

• Profit Sharing and Results Program (PPR).

• Parking, transportation allowance, or company shuttle.

• USE Program: subsidy toward the purchase of equipment used for work, which may also be utilized for personal purposes.

• Flexible benefits (TotalPass, life insurance, private pension, medical and dental coverage, and food allowance).

• Remote work opportunities.

• Flexible working hours.

• Access to coworking spaces globally.