Supports Clinical Trial Team while adhering to SOPs and ICH/GCP GuidelinesPartners with Quality Control personnel while conducting in-process Trial Master File reviews/audits to ensure SOP and ICH/GCP complianceCollaborates with management in the development of study start-up and document management processesEstablishes and maintains good working relationship with CRAs, investigational sites, and vendorsSubmits study documentation to Central Institutional Review Boards (IRBs) from study start-up through closeout.Assists Investigator sites with Local Institutional Review Board (IRBs) submissionsRegisters and updates study information on ClinicalTrials.govCollects and reviews regulatory documents (1572s, Financial Disclosure Forms, CVs, Medical Licenses, etc.) for accuracy and completeness from study start-up through close-outLiaises with Associate Directors, Clinical Trial Managers, and other departments to ensure quality, overall site managementUpdates, maintains, and ensures accuracy of study-specific databases and spreadsheetsAssists in the development of Sponsor Oversight PlansReviews and edits study-related plans and correspondenceManages online study communities

Supports Clinical Trial Team while adhering to SOPs and ICH/GCP GuidelinesReviews and negotiates Informed Consent Forms and Confidentiality Agreements with investigational sites. Secures document approval from the Local Trial Manager.Establishes and maintains good working relationship with Investigator site personnelCollects and reviews regulatory documents (1572s, Financial Disclosure Forms, CVs, etc.) for accuracy and completeness from study start-up through close-outProcesses, tracks, and distributes documents as required for protocol amendmentsPartners with Local Trial Manager, Contracts and Grants Associate, and Site Manager to ensure overall site managementPrepares for Quality Assurance and FDA audits in partnership with the Sponsor, Local Trial Manager, and Site Managers. Responds to audit findings as appropriate.Updates, maintains, and ensures accuracy of study-specific databases and spreadsheetsAssembles, maintains, and audits Trial Master File(s)

Review essential regulatory documentsCommunicate with Sponsor, sites, and Clinical Research Associates to ensure all regulatory documents are on-file and currentObtain, review, and process regulatory and administrative documents received from investigational sites Contact study personnel at sites regarding administrative issuesResolve queries of CRF data with study site personnelPrepare Trial Master File for Sponsor auditHosted sponsor audit with QA ManagerResolve issues, questions, and requests for additional study suppliesLayout, design, and proofread newslettersProvide clerical and administrative support to project teamsSet-up and maintain project and investigator filesGenerate and maintain study-specific tracking spreadsheets (e.g. patient, enrollment, regulatory documents, site visits)Prepare regulatory binders for investigational sites

Conceptualized, designed, and wrote copy for full- and spot-color print collateralScanned, retouched, and color-corrected digital imagesEdited clients’ files with a focus on typography, color correction, and prepress productionCollaborated with account executives to ensure design and copy integrity Prepared a manuscript (I Slept with Joey Ramone - A Family Memoir) for publication by reviewing and editing copy to detect errors in spelling, punctuation, syntaxDocument and audio transcription Assisted with television documentary proposals