Safety Documentation Coordinator

divh2Clinical Trial Documentation Specialist/h2pThis role is subject to a hybrid work arrangement requiring a minimum of 2 pre-determined days per week in our mid-town office./ph3Summary/h3pThis 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./ph3Essential Duties and Responsibilities/h3h4Primary Responsibilities - Documentation Management/h4ulliVerifies compliant filing of and organizes all clinical trial deliverables including adverse event source documents, training documentation, onboarding documentation, notes to file, and regulatory documents/liliDevelops and maintains standardized file nomenclature system according to document type and Foundation standards/liliTranscribes and updates status of all deliverables in approved Foundation tracking tools/liliMaintains study-related documents (e.g. protocols, investigator site file binders, manual of operations, regulatory binder)/liliResponsible for tracking all essential study related documentation using Foundation approved tracking systems/liliPerforms quality control checks on documentation for completeness, accuracy, and compliance/liliManages electronic and physical filing systems ensuring proper version control/liliGenerates regular reports on documentation status and compliance metrics/liliCoordinates document archival and destruction processes according to SOPs/li/ulh4Secondary Responsibilities - Safety Administration Support/h4h5Administrative Safety Associate II Support/h5ulliReceives package/notifications for designated safety trials checking for completeness/liliPrints or stores electronic event source document packets/liliPerforms initial QC of event source packets/liliCreates standardized patient E-charts within Foundation network files/liliAssists with redaction of safety documents when applicable/liliLogs events into tracking databases/liliManages administrative part of safety queries/liliRuns safety trial reports as requested/liliPerforms safety event reconciliation as requested/liliFiles Clinical CRFs into patient subject folders/li/ulh5Safety Research Associate Support/h5ulliManages calendars and coordinates meeting preparations with multiple parties/liliWorks with sponsors, vendors, and in-house personnel to arrange meetings/liliMakes travel arrangements, orders food, and reserves conference rooms for safety meetings/liliPrepares documentation and media (i.e., Angios, QCA) for Clinical Event Committee (CEC) meetings/liliSupports post meeting activities including meeting minutes for CEC DSMB meetings as requested/liliCreates and maintains regulatory documentation for all committee members/liliDevelops adjudication forms upon request/liliReviews documents for formatting, spelling, details and quality prior to submission/liliProcesses billing receipts and orders supplies/li/ulh3General Responsibilities/h3ulliParticipates in project team meetings/liliParticipates in developing and maintaining SOPs, guidelines and work instructions/liliParticipates in development and review of corrective action plans for audits/liliWorks collaboratively with QA on audit preparation/liliTrains new personnel on documentation standards and safety procedures/liliRemains up to date in all department and foundation standard operating procedures/liliCommunicates with Project Manager for problem resolution/liliPerforms additional duties as assigned/li/ulh3Qualifications/h3ulliBachelors degree preferred, Associates degree required/lili2-3 years of experience in clinical trials, healthcare documentation, or records management/liliExperience with safety administration in clinical trials preferred/liliKnowledge of GCP and regulatory documentation requirements beneficial/liliStrong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment. Must be able to triage priorities./liliMust be able to understand the expectations and daily workflow of physicians./liliWillingness and flexibility to occasionally work evenings and weekends./liliAbility 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./liliAbility to analyze information and solve problems related to organizing and logging of important documents./liliComputer literate with advanced experience with Microsoft Office products and an interest in AI./li/ulh3Benefits/h3ulliChoice of health plans include medical, Dental, and vision coverage/liliCompany-paid short-term and long-term disability and life insurance/liliHealth and dependent care flexible spending accounts/liliPre-tax travel expenses through TransitChek program/lili401(k) plan/liliGenerous paid time off (PTO)/liliFourteen paid holidays each year/li/ulh3Compensation/h3pThe hiring range for this position is $48,000 - $55,000 per year. The annual salary that will ultimately be offered to the successful candidate will depend on job-related knowledge, education, skills, and experience./ppTo be considered for this opportunity, please submit your resume./ppBe sure and visit our web site to learn more about how we strive to enhance and save patient lives every day is an equal opportunity employer./p/div

Cardiovascular Research Foundation