FSP CRA II

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

📋 Description

• Execute and coordinate all elements of clinical monitoring and site management.

• Carry out remote or in-person visits to evaluate protocol and regulatory adherence while overseeing documentation.

• Manage sponsor protocols and guidelines across various monitoring environments.

• Ensure that trials comply with approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs.

• Maintain audit readiness and foster collaborative relationships with investigational sites.

• Monitor investigator sites using a risk-based approach, including RCA, SDR, SDV, and CRF review.

• Evaluate investigational products through physical inventory checks and record reviews.

• Document findings in reports and letters, escalating deficiencies until resolved.

• Stay in contact with sites between visits to confirm adherence to protocols, resolve issues, and ensure timely data entry.

• Participate in investigator payments, meetings, site identification, site initiation, trial closeout, and retrieval of trial materials.

• Ensure that essential documents are complete and conduct on-site file reviews.

• Provide updates on trial status and progress to the Clinical Team Manager and refresh study systems.

• Facilitate communication among sites, the client organization, and the PPD project team.

• Address company, client, and regulatory demands, audits, and inspections.

• Complete expense reports and timesheets.

• Assist with project publications/tools and contribute to initiatives for process improvement.

• Travel frequently to site locations, typically 60–80%, which may include overnight stays.

⛳️ Requirements

• Bachelor's degree in a life sciences-related field, or Registered Nursing certification, or equivalent formal academic/vocational qualification.

• Prior experience equivalent to at least 1 year as a clinical research monitor, or completion of the PPD Drug Development Fellowship.

• Valid driver's license where applicable.

• Consideration may be given for equivalency through a combination of relevant education, training, and/or directly related experience.

• Demonstrated clinical monitoring capabilities.

• Understanding of medical/therapeutic areas and medical terminology.

• Familiarity with ICH GCPs, applicable regulations, and procedural documentation.

• Strong critical thinking, root cause analysis, and problem-solving abilities.

• Ability to apply Risk Based Monitoring concepts and processes effectively.

• Proficient oral and written communication skills, including interaction with medical personnel.

• Strong customer focus, listening skills, attention to detail, and capability to identify underlying issues.

• Excellent organizational, time management, and interpersonal skills.

• Adaptability and flexibility in various situations.

• Ability to work autonomously as well as part of a team.

• Proficient in Microsoft Office and capable of learning relevant software.

• Good command of the English language and grammar.

• Effective presentation skills.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.