Safety Documentation Coordinator

This role is subject to a flexible hybrid work arrangement requiring a minimum of 1-2 pre-determined days per week in our mid-town office.

SUMMARY

This position ensures the integrity and accessibility of all clinical trial documentation through systematic review, filing, standardization, and tracking. The incumbent manages all deliverables including adverse event source documents, training documentation, onboarding materials, and regulatory files while maintaining real-time status updates in Foundation-approved tracking systems. As an integral part of the safety team, this role supports the safety team with maintaining an audit ready posture.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Primary Responsibilities - Documentation Management

• Verifies compliant filing of and organizes all clinical trial deliverables including adverse event source documents, training documentation, onboarding documentation, notes to file, and regulatory documents
• Develops and maintains standardized file nomenclature system according to document type and Foundation standards
• Transcribes and updates status of all deliverables in approved Foundation tracking tools
• Maintains study-related documents (e.g. protocols, investigator site file binders, manual of operations, regulatory binder)
• Responsible for tracking all essential study related documentation using Foundation approved tracking systems
• Performs quality control checks on documentation for completeness, accuracy, and compliance
• Manages electronic and physical filing systems ensuring proper version control
• Generates regular reports on documentation status and compliance metrics
• Coordinates document archival and destruction processes according to SOPs

Secondary Responsibilities - Safety Administration Support


** Administrative Safety Associate II Support

• Receives package/notifications for designated safety trials checking for completeness
• Prints or stores electronic event source document packets
• Performs initial QC of event source packets
• Creates standardized patient E-charts within Foundation network files
• Assists with redaction of safety documents when applicable
• Logs events into tracking databases
• Manages administrative part of safety queries
• Runs safety trial reports as requested
• Performs safety event reconciliation as requested
• Files Clinical CRFs into patient subject folders

** Safety Research Associate Support

• Manages calendars and coordinates meeting preparations with multiple parties
• Works with sponsors, vendors, and in-house personnel to arrange meetings
• Makes travel arrangements, orders food, and reserves conference rooms for safety meetings
• Prepares documentation and media (i.e., Angios, QCA) for Clinical Event Committee (CEC) meetings
• Supports post meeting activities including meeting minutes for CEC & DSMB meetings as requested
• Creates and maintains regulatory documentation for all committee members
• Develops adjudication forms upon request
• Reviews documents for formatting, spelling, details and quality prior to submission
• Processes billing receipts and orders supplies

General Responsibilities

• Participates in project team meetings
• Participates in developing and maintaining SOPs, guidelines and work instructions
• Participates in development and review of corrective action plans for audits
• Works collaboratively with QA on audit preparation
• Trains new personnel on documentation standards and safety procedures
• Remains up to date in all department and foundation standard operating procedures
• Communicates with Project Manager for problem resolution
• Performs additional duties as assigned

QUALIFICATIONS

• Bachelor's degree preferred, Associate's degree required
• 2-3 years of experience in clinical trials, healthcare documentation, or records management
• Experience with safety administration in clinical trials preferred
• Knowledge of GCP and regulatory documentation requirements beneficial
• Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment. Must be able to triage prioritizes.
• Must be able to understand the expectations and daily workflow of physicians.
• Willingness and flexibility to occasionally work evenings and weekends.
• Ability to effectively communicate verbally with physicians, nurses, pharmaceutical companies, other Foundation employees, and outside vendors as required. Ability to communicate effectively when reading and writing e-mail, memos and presentations.
• Ability to analyze information and solve problems related to organizing and logging of important documents.
• Computer literate with advanced experience with Microsoft Office products and an interest in AI.

BENEFITS

• Choice of health plans include medical, Dental, and vision coverage
• Company-paid short-term and long-term disability and life insurance
• Health and dependent care flexible spending accounts
• Pre-tax travel expenses through Transit Chek program
• 401(k) plan
• Generous paid time off (PTO)
• Ten paid holidays each year

COMPENSATION

The hiring range for this position is $48,000 - $55,000 per year. The…