Clinical Trial Assistant Resume

SUMMARY:

Proactive and creative problem solver
Highly organized time manager
Ability to focus attention to detail
Inquisitive thinker and possessor of keen communication skills
Ability to see projects to fruition
Team player who can forge relationship with colleagues
Performs tasks autonomously
Proofreading and strong quality control check abilities

TECHNICAL SKILLS:

Languages/Ms office/Others tools: Microsoft Office (Excel, Outlook, PowerPoint, Word), ARGUS, ISI Toolbox and SharePoint, Adobe Photoshop, Illustrator, InDesign, QuarkXPress, WordPress CMS, CSS, Evernote, SEO, Adobe Acrobat, Distiller and plug - in Compose for Acrobat, GSRD-GRT, Records Management, Document creation of CMC sections of eCTD in EZ Docs 3.0, Archiving and retrieval of documents within Documentum, PC and Apple Macintosh platforms, strong working knowledge of Adobe Acrobat to delete, insert, replace, crop, extract, or rotate pages

PROFESSIONAL EXPERIENCE:

Confidential

Clinical Trial Assistant

Responsibilities:

Performed quality control checks of all electronic Trial Master File documentation, in order to identify missing and present records.
Provided hyperlink on Excel spreadsheet on location of documentation.
Responsible to execute assigned tasks and ensure that project deliverables were met.

Confidential, Bridgewater, NJ

Global Submissions & Reporting Associate

Responsibilities:

Reviewed and tracked all generated AEMs and CIOMs adverse events that were submitted electronically to Confidential ’s licensing partners.
Performed MedDRA drug coding in accordance with guidelines and conventions.
Responded to email requests and reviewed and resolved all case queries.

Confidential, Plainsboro, NJ

Regulatory Submissions and Document Specialist

Responsibilities:

Responsible for the publishing and assembly of 510(k)s and PMAs paper and electronic submissions to the FDA.
Responsible to produce multiple leveled bookmarks, sections tabs, list of appendices, list of figures, list of tables and hyperlinks within medical device documentation in order to facilitate easy page navigation.
Applied additional watermark, stamp, and masking within the document as requested.
Prepared copy of the Medical Device User Fee Cover Sheet along with payment for submission to the FDA US Bank Lockbox.

Confidential, Rahway, New Jersey

Regulatory Operations Specialist

Responsibilities:

Responsible for the creation, review, assembly, publishing, printing, delivering and archiving of regulatory submission documents.
Quality control checks of US, and ROW submissions to the FDA of Product Safety Update Reports, Assembled Clinical Study Reports (CSRs), INDs, NDAs, sNDAs, Periodic Safety Reports, NDAs, BLAs, Case Report Tabulations, Case Report forms, Protocols, SAS files, CIOMs Reports, CTDs, Product Inserts, Labeling and eCTDs of regulatory documents for accuracy and navigation of bookmarks and hyperlinks to proper navigation.
Assembled Chemistry, Manufacturing and Control (CMC) submission components, tabs, paper size, and other format features utilizing EZ Docs 3.0, checked electronic proof and submitted for printing.
Archived regulatory documents and medical journal articles by dropping into Documentum.

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