Haritha Gopal Email & Phone Number

Haritha Gopal is a Clinical Research Associate at The Centre for Dermatology.

• Clinical Research Associate

  The Centre For Dermatology

  Mar 2023 - Present - Richmond Hill, Ontario, Canada

  • Assist in investigator study site selection and study start-up.• Create clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), and monitoring visit templates and reports.• Implement and monitor clinical trials to ensure sponsor/investigator obligations are met and are compliant with applicable local requirements and FDA and ICH guidelines.• Conduct monitoring visits to confirm protocol compliance, assess qualifications of study personnel, ensure “Good Clinical Practice”, and conduct close-out visits.• Identify site issues and initiate correction plans based on monitoring reports.• Perform investigative site file reconciliation: requests any new and updated site-related essential and nonessential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements.• Verify data in source documents agree with the source, initiate data query resolution, and confirm resolution promptly.• Ensure subject safety and adverse event reporting to the sponsor and IRB/IEC.