Contractor, Clinical Trial Associate

Responsibilities:
- Maintain Trial Master Files (TMF) for assigned clinical trials: receipt, review, QC, tracking, and filing per SOPs.
- Ensure TMF is inspection ready.
- Provide TMF metrics to internal/external stakeholders.
- Partner cross-functionally to follow the trial master oversight plan.
- Develop/maintain tracking tools for patient recruitment, site ramp-up, monitoring visits, and site payments.
- Assist Clinical Operations with CRO oversight as appropriate; participate in Clinical Trial Working Groups.
- Assist in reviewing monitoring visit reports.
- Review site-specific Informed Consent Forms.
- Track site feasibility questionnaires.
- Assist in planning meetings/events for the Clinical Operations team.
- Reconcile invoices to contracts/budget and assist with investigator site payments.
- Prepare and manage study communications (newsletters, study updates).
- Record/prepare/distribute meeting minutes for assigned trials (or as designated by VP of Clinical Operations).
- Support preparation of internal/external trial documentation in line with GCP requirements and the study protocol.

Minimum Requirements:
- 2+ years’ experience in Veeva Vault.
- 2+ years’ experience in clinical operations (CRO and Sponsor experience desired).
- Knowledge of FDA regulatory requirements and ICH/GCP guidelines.
- Demonstrated ability partnering with CROs and vendors.
- Proficiency: Veeva TMF, Word, Excel, PowerPoint, SmartSheet.
- Proactive, efficient in fast-paced/high-change environments.
- Excellent written and oral communication; outstanding organization.
- Bachelor’s degree desired, preferably in a science or healthcare discipline.

Location:
- Open to candidates from any location; preference for east coast locations.