Position Description: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.
Responsibilities and Duties:- 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.
Minimum 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
- Bachelor's degree desired, preferably in a science or healthcare related discipline
Location: While our corporate headquarters are located in New York City, this position is open to candidates from any location with a preference for east coast locations.
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