Data Entry Quality Assurance

CURRICULUM VITAE

CURRENT ADDRESS: Beverley Jones

Global Drug Safety

Telephone:908-***-****

E-mail: ******@*******.***

EDUCATION:

North Carolina Agricultural and Technical State University, Greensboro, NC

27401

BS Degree: DeVry, Fall 2015

Center for Professional Innovation and Education, Malvern, PA

Effective Document Management, 2006

Duke Clinical Research Institute, Durham, NC

CCDM Relational Database I-IV, 2006

Raritan Valley Community College, North Branch, NJ, 2006

Clinical Data Management, 2006

University of Medicine and Dentistry of NJ, USA, 2004

Dental Hygiene, 2006

Essex County College, Newark, NJ

Business Administration, 2004

COMMITTEES/SOCIETIES/PROFESSIONAL AFFILIATIONS::

Tri-State Dental Hygiene Society

National Dental Hygiene Association

Daughter of the Elks

WORK EXPERIENCE:

Celgene, Berkeley Heights, NJ 07922 12/02/2013 -

1/30/2014

Data Entry Coordinator (Contractor)

. To perform safety data entry within Celgene's corporate safety

database for developmental and marketed products for all adverse event

reports serious and non-serious

. Data entry aspects of AE handling virtually from home office

. Proactive identification of standards and system enhancements

. Perform MedDra electronic or manual coding, as necessary, according

to project specific guidelines.

. Undertake additional assignments on an as-need basis including, but

not limited to, execution of pre-defined follow-up measures and due

diligence; non-AEs.

. Tracking of follow up measures

. Conduct full data entry from source document as per the GDSRM

conventions -all cases globally including complex cases involving

medical records and literature cases

. Interpretation of medical source documents for data entry into the

safety database including extraction of appropriate laboratory data

and diagnostic testing

. Identify and confirm the appropriate timeline path for all cases based

on the serious criteria

High Point Clinical Trials Center, High Point, NC

7/2011 - 7/1/2012

Clinical Operations Coordinator (contract)

. Perform all job responsibilities in accordance with standards of good

clinical practice, clinical SOPs, OSHA guidelines, Federal and local

regulations

. Perform data entry in a timely manner according to data entry

guidelines, protocol and sponsor instructions

. Perform quality checks on data entry into the EDC system.

. Perform query resolution in a timely manner

. Perform source data verification

. Assist monitor during routine visits

. Create spreadsheets for Adverse Event and other study trends

. Communicate with and meet with Sponsor/HPCTC staff as needed

. Perform quality checks on study participants charts

. Ensure documents are organized and stored in document control room

. Ensure filing of documents in a timely manner

. Assist in development of recruitment materials and timelines

. Assist in study participants recruitment

. Create and modify source documents

. Develop and create site forms

. Ensure study binders and source documents are available for study

conduct

. Assist regulatory staff as needed

. Perform informed consent process

. Perform medical history and completion of inclusion exclusion forms

. Participate in study procedures

. Assist in organizing study supplies and overseeing study logistics

Halian Technical Service, Neshaminy Interplex, Trevose, PA,

2/2008 - 3/2009

Quality Assurance Documentation Administrator

. Issue Document Identification

. Format Documents According to DMP

. Manage Review/Approval Process

. Maintain Document Index

. Manage Document Changes and Version Control

. Track Status Throughout Lifecycle

. Control and Distribution

. Archival and Destruction

. Collection of Required Evidence

. Maintain Document Status on Company Server

. Import/Export Approval Documentation

Abraxis Bio Sciences, Durham, NC,

4/2007 - 10/2007

Drug Safety Administrator

. Perform receipt of Serious Adverse Events (SAE) cases. Pull and re-

file cases.

. Provide timely feedback to sites and other parties when faxed

transmission is incomplete to ensure the accurate, complete and

timely reporting of SAEs.

. Enter the case into the tracking log; check whether it is an

initial, a follow-up or a duplicate report; and place the case in

the appropriate folder. Create a new folder for an initial case

and label int. Delete all confidential patient information from

the received report. Record protocol number and site/patient

number, if applicable, on all source documents. Provide the report

to the person conducting case evaluation.

. Enter data into safety database. Ensures accurate entry.

. Perform MedDra electronic or manual coding, as necessary, according

to project specific guidelines.

. Support Drug Safety Surveillance personnel with faxing reports,

narratives, and queries. Place confirmations into the appropriate

folder.

. Perform mailings of Investigational New Drug Safety Reports

according to the provided guidelines. Ensure that the appropriate

documentation is provided to all parties and is stored in the

folder and in the designated place.

. Assist in preparation and distribute Investigator Notification

Letters in a timely manner.

. Prepare and send SAE reports to the manufacturers of comparator

products. Keep the log of all reports.

. Serve a Drug Safety Team Member for Drug Safety Surveillance

projects.

. Maintain a through understanding of the protocols and scope of

work.

. Assist Drug Safety Scientists with assigned tasks, database

reconciliation, advise event follow-up and case closure.

. Communicate problems and issues to Drug Safety Manager in a timely

manner.

. Actively participate in Drug Safety Surveillance project team

meetings, provide process improvement suggestions and adhere to

required timelines for completion of adverse events reporting.

Daiichi Asubio Pharmaceuticals, Inc., Rochelle Park, NJ,

11/2004 - 3/2007

Documentation Specialist

. Manage the Asubio Document Management System; create templates and

forms in support of document review and approval; arrange concurrence

meetings.

. Support Clinical Operations; perform Clinical Data functions using

GCPs and GCDMPs; maintain site evaluations.

. Create schematics using MS software; create PowerPoint presentations.

. Create and maintain databases using Access and Excel.

. Support CRA and maintain study-related documents.

. Make travel arrangements and expense reports for domestic and

international site visits, IB meetings and kickoff meetings.

. Maintain positive interaction/communications with Vice President of

Research and Development and Director of Clinical Research.

Progressive Dental Care P.C., South Orange, NJ,

1/2001 - 11/2004

Dental Hygienist

. Ensured adherence to state and federal regulations.

. Researched dental health enrichment programs.

. Provided patient prophylaxis; delivered topical anesthesia.

. Measured and recorded periodontal pocket depth to determine health

status of the gingiva.

. Treated disease tissue with doctor-indicated recommendations.

. Established a monthly oral health topic.

. Maintained updated oral health literature for patient education.

. Planned office workshops and table clinics for current health topics.

. Established a free sample program with dentifrice companies to aid in

patient awareness.

COMPUTER SKILLS:

Highly organized and efficient with strong managerial and problem

resolution skills. Created and validated a document management system and

secure folder structure for central server. Implemented a GCP-compliant

system for review, revision, and approval of standard operating procedures

and accompanying documentation; support the clinical function and maintain

study records.

Contact this candidate