Clinical Trial Associate

Summary

Join Syndax Pharmaceuticals as a Contractor, Clinical Trial Associate (CTA) and contribute to the development of innovative cancer therapies. The CTA will support the Clinical Operations team in conducting clinical trials, managing aspects of trials, and ensuring timely and compliant completion. Key responsibilities include maintaining Trial Master Files (TMF), providing TMF metrics, assisting with tracking tools, working with CROs, reviewing reports, and preparing study communications. The ideal candidate will possess two years of Veeva Vault experience, clinical operations experience in both CRO and sponsor settings, knowledge of FDA regulations and ICH/GCP guidelines, and excellent communication and organizational skills. A Bachelor's degree in a science or healthcare-related discipline is preferred. This position offers remote work flexibility with a preference for East Coast locations.

Requirements

• Two years’ experience in Veeva Vault
• Two or more years’ experience in clinical operations- experience in both a CRO and Sponsor setting desired
• Knowledge of FDA regulatory requirements and ICH/GCP guidelines essential
• Demonstrated efficiency in partnering with CROs and vendors
• Computer proficiency (Veeva TMF, Word, Excel, PowerPoint, Smart Sheet)
• Work proactively and efficiently in a fast-paced, high change environment
• Excellent written and oral communication skills
• Outstanding organization skills

Responsibilities

• Maintain the Trial Master Files (TMF): Responsible for the on-going management of the TMF for assigned clinical trials. This is inclusive of receipt, review, QC, tracking and filing of all documents per the Syndax SOPs required within the conduct of assigned clinical trials
• Ensure TMF is inspection ready
• Provide TMF metrics to internal and external stakeholders
• Work closely with all cross functions to adhere to the trial master oversight plan
• Assist with the development and maintenance of tracking tools for patient recruitment, site ramp-up, monitoring visits and site payments
• Work with Clinical Operations to assist in the oversight of CROs, as appropriate, to ensure the successful conduct of clinical trials, including attending and participating in Clinical Trial Working Groups as needed
• Assist in reviewing monitoring visit reports to ensure proper conduct and oversight as needed
• Review site-specific Informed Consent Forms
• Track site feasibility questionnaires
• Assist in the planning of various meetings and events for the Clinical Operations Team
• Reconcile invoices to their corresponding contracts and budget and assist with investigator site payments
• Prepare and manages study communications including newsletters and study updates
• Records, prepares and distributes meeting minutes for assigned clinical trials or as designated by the VP of Clinical Operations
• Work closely with Clinical Trial Managers to assist with preparation of all external and internal documentation for assigned trials to ensure it's completed in accordance with GCP regulatory requirements and consistent with the study protocol

Preferred Qualifications

Bachelor's degree is desired, preferably in a science or healthcare related discipline

Benefits

#LI-Remote