Freelance Clinical Research Associate

• Function operationally as a member of a Project Team
• Initiate, monitor, and close out clinical study sites
• Monitor clinical trials on-site and remotely according to SOPs, GCP, ICH guidelines, and applicable regulations
• Perform monitoring activities to assess subject safety, data integrity, and quality
• Verify informed consent procedures and protocol compliance
• Review electronic or paper CRFs and subject source documentation
• Verify management and accountability of Investigational Product
• Prepare Monitoring Visit Reports, document findings and corrective/preventive actions, and update tracking systems
• Communicate site issues and required action items
• Deliver site documents to eTMF or paper TMF and verify Investigator Site File maintenance
• Participate in audits and inspections, including preparation and follow-up
• Order, ship, and reconcile clinical investigative supplies when applicable
• Update CTMS and other project systems with accurate site-level information

• Bachelor’s Degree, preferably in life science or nursing; or equivalent
• 1–3 years of relevant clinical experience or relevant academic background around clinical trial or clinical development activities
• Experience in Urology or Overactive Bladder is required
• Ability to work in a fast-paced environment with changing priorities
• Understanding of basic medical terminology and science associated with assigned drugs and therapeutic areas
• Understanding of Good Clinical Practice regulations and ICH guidelines
• Ability to work independently and in a team matrix organization
• Strong written and verbal communication skills
• Fluent in English and Portuguese
• Excellent organizational skills
• Technology savvy with good software and computer skills
• Ability and willingness to travel up to 60–80%, overnight and abroad if applicable

• Competitive compensation package
• Comprehensive benefits
• Opportunity for personal and professional growth
• Collaborative and innovative work environment
• Team focused on making a difference in patients’ lives