Cardiovascular Research Foundation · 4 days ago
Safety Documentation Coordinator
New York, NY
Full-time
Hybrid
Entry, Mid Level
$48K/yr - $55K/yr
2+ years expCardiovascular Research Foundation is dedicated to enhancing and saving patient lives. The Safety Documentation Coordinator ensures the integrity and accessibility of all clinical trial documentation while managing deliverables and maintaining compliance with regulatory standards.
Health Care
Responsibilities
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
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
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
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
Qualification
Required
Associate's degree required
2-3 years of experience in clinical trials, healthcare documentation, or records management
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
Preferred
Bachelor's degree preferred
Experience with safety administration in clinical trials preferred
Knowledge of GCP and regulatory documentation requirements beneficial
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 TransitChek program
401(k) plan
Generous paid time off (PTO)
Ten paid holidays each year
Company
Cardiovascular Research Foundation
The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving.
51-200 employees
H1B Sponsorship
Cardiovascular Research Foundation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (3)
2023 (3)
2022 (1)
2021 (1)
2020 (5)
Funding
Current Stage
Growth StageLeadership Team
Donald L. Abrams
Chief Legal Officer
Shawn Ricketts, SHRM-CP
Talent & Engagement Partner
Recent News
2025-11-08
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