Remote Clinical Research Associate

Summary

Join Syndax Pharmaceuticals as a Clinical Research Associate (CRA) to contribute significantly to the management and execution of clinical trials, building relationships with site personnel and collaborating with cross-functional team members.

Responsibilities

• Assist in the development of informed consent forms
• Assist in the development of study training materials, study plans and study tools
• Provide critical review of site monitoring visit reports
• Track metrics for monitoring visits and monitoring visit reports and document trends
• Ensure the Monitoring Plan is followed
• Oversee the performance of CROs and third-party vendors, including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Clinical Operations Management
• Conduct remote and/or on-site monitoring oversight visits as specified in the Oversight Plan for each assigned study
• Work closely with Clinical Supplies to ensure timely drug delivery to sites and resolve outstanding site action items related to investigational product
• If applicable, ensure study drug blind is maintained in all interactions with blinded study team members and site staff
• Participate as needed in site study drug training (unblinded CRA role)
• Perform in-house clinical study data review
• Create and maintain study-related tracking tools
• Assist in the review and maintenance of the clinical Trial Master File; perform study file audits
• Participate in review and QC of study documents (protocol, ICF template(s), TMF, etc.) and the user acceptance testing of EDC and IRT systems
• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance, or support and coordinate with the CRO’s CRAs on these activities
• Provide guidance at the site and project level towards audit readiness standards and supports preparation for audits, Health Authority Inspections and required follow-up actions
• Communicate any Site, CRO or Vendor escalations or issues to upper management as soon as identified
• Work with the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., CRO, Vendors, Regulatory, Investigator Sites, etc.)
• Partake in regular team meeting/teleconferences
• Participate/present at CRO, Vendor and Investigator Site meetings as necessary
• Participate/present at Site and Investigator Meetings as necessary
• Regular Travel Required