Contractor, Clinical Trial Associate

Syndax Pharmaceuticals•New York, NY

21d•Remote

About The Position

The Contractor, Clinical Trial Associate will work with Clinical Operations team to support the conduct of clinical trials. The Clinical Trial Associate may provide support for various clinical trials and may manage certain aspects of the clinical trials. The Clinical Trial Associate will partner with the Clinical Project Managers and Clinical Trial Managers to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.

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

Nice To Haves

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

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.