Clinical Trial Mgmnt System(CTMS),Document Mgmnt, MicroSoft Office

Mary Crudup

Rolesville, NC ***** 719-***-**** ac3daz@r.postjobfree.com

PROFESSIONAL PROFILE

Seasoned Document Management & Clinical Trials professional with an extensive background in FDA, GCP/ICH, & ISO regulated environments supporting the installation, updating/ changing, maintenance, and review of document control systems and processes.

Customer-service oriented with strong organization and leadership skills, the ability to facilitate efficient workflows and interact effectively with project team members.

Follows policies, procedures, and guidelines to assure attention to detail and consistent quality and time management competency.

Experienced with Microsoft Office Suite and Microsoft SharePoint. Proficient in Global Data Operations, Clinical Operations, Good Documentation Practices (GDP) and GCP Regulatory Authority Inspections.

Strong skills in managing and maintaining Document Control Systems (DCS), filing and archiving critical/essential documents and materials; performing ongoing data quality checks and reviews.

Detailed knowledge of data processing including receipt, entry verification, filing, tracking, maintenance control; and query resolution to comply with study guidelines.

KEY QUALIFICATIONS,

Controlled Documentation Document Management Systems (CTMS)

Quality Assurance, CRF Track Processing Oracle Systems

InnTrax, Informatics, and InFORMant

Leadership & Management Medical Terminology

Business Office Operations Medical Office Procedures

HIPAA Compliance Medical Practice Management Systems

Insurance Billing Procedures Healthcare Claim Cycle Insurance Verification

Maintaining Prescription Line, Appointment Scheduling, Charting, Filing Processing Payments

PROFESSIONAL EXPERIENCE

Conduent – Raleigh, NC 07/2017 – 10/2017

Customer Care Representative

Work with customers in a call center environment to resolve inquiries and provide trouble-shooting

solutions as needed relating to Medicare-D mail-order prescriptions.

Navigate through multiple computer applications with speed and accuracy using the CareSource/ PeopleSafe/Marx/Fazal/Faucets/ MedHok/Citrix/ and FileNet databases.

Read and interpret documents to recommend products best suited to customer needs.

Review and handle premium insurance billing and claims cycle process as needed.

Process orders, answering product and service questions; suggesting information about other products and services.

Aerotek – Durham, NC 12/2015 – 07/2016

Clinical Trials Assistant

Assist Clinical Project Manager (CPM) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.

Support the project team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and SOP guidelines.

Aide CPM with prep answering product and service questions; suggesting information about other products and services.aration, handling and distribution of Clinical Trial Supplies and accurate tracking information.

Management and tracking assistance of Case Report Forms (CRFs), queries, and clinical data flow.

Central liaison for teams in designated projects handling site management, communications and related documentation; and assuring data validity and site compliance of required document submissions.

Responsible for both the collection and review of all essential/regulatory documents from investigative sites; perform frequent reconciliation and quality control checks to assess overall status of trial master files (TMFs).

Prepare, distribute, and update Onsite Study Files (OSF) and OSF checklists.

Confirm the review and data validity of site-specific Informed Consents (ICFs) before IRB approval/submission.

Work closely with clinical sites through the collection, review and IRB/ethics approval process of required regulatory documents.

Prepare and distribute agenda and meeting minutes for internal project meetings.

UCB BioSciences – Raleigh, NC 03/2011 – 12/2015

Data Management Document Processor

Collaborate with Data Managers to manually enter data; scanning and uploading 10,000 plus pages in 30 days for RDC conversion.

Prepare data for processing by reconciling and authenticating information, accuracy checks and adjusting/weighing the data.

Process receipt, entry verification, scanning, uploading, and filing of data for 20+ clinical trials.

Batch TMF documents for outbound shipment to Phlexglobal/Iron Mountain; track acknowledgement of receipt of all batches.

File and archive all essential documents/materials related to clinical trials where Clinical Project Management Resources are assigned within Global Clinical Sciences and Operations, in compliance with GLP, GCP and national/regional/international regulations.

Maintain compliance of all documents for both active and inactive trials; timely response to requests for site documents being pulled from and re-filed to TMF; ensure study-specific protocol guidelines are carried out in a secure, confidential and controlled manner.

Performed ongoing quality checks and review of TMF data for assigned trials; communicate discrepancies or findings to Senior Management.

Military Personnel Division (M.P.D.) – Fort Monmouth, NJ 08/2007 – 08/2010

Personnel Technician

Provide various administrative, personnel and clerical duties for the Chief of Military Personnel Division as a Finance Clerk, Reassignment Specialist, and Verifying Official.

Successfully manage 200+ soldiers with personnel deployments, permanent/temporary change of station orders, and financial needs through the Defense Finance Accounting Services.

Resolve problems that often involved researching both local and national policies, precedents, regulations, directives, and presidential orders that involved military entitlements.

Authenticate, verify, and issue 400+ military ID cards and common access cards monthly to active duty military, reserve, and National Guard members, retirees, family members, civilian personnel, and other eligible recipients.

Answer personal inquiries via telephone or written correspondence concerning all aspects of the military personnel service and support programs.

Prepare correspondence referencing regulations, precedents, and guides pertinent to military personnel administration.

Provide other miscellaneous administrative support as needed.

Holy Redeemer Healthcare Service – Long Branch, NJ 10/2006 – 08/2007

Records Clerk

Successfully manage, maintain, and update 125 ISO patient records; handle scheduling of appropriate medical personnel based on physician’s recommendations.

Maintain patient confidence by keeping patient records information confidential.

Perform Data entry of demographic characteristics (i.e., patient history, diagnostic procedures, and treatment) into database computer system.

Retrieve patient medical records by following chart-out procedures; Deliver charts to assigned areas of the hospital by following established routing procedures.

Act as a liaison between patients, family members, home-care agencies and staff related to patient schedules, quality service received and patient care.

EDUCATION

Ultimate Medical Academy – Associate of Science Degree – Healthcare Management, 2016

High Academic Honors Recognition / Dean’s List.

REFERENCES

Available Upon Request

Contact this candidate