Administrative Assistant Data Entry
Resume:
Jessica Ortega
*** ******* **** ******** ** *****
**********@*****.***
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I am motivated, energetic and well-spoken professional with an eye for
detail and a passion for excellence seeking to continue my career
growth in a university setting. I am a strong team player who is
capable of working independently or as part of a team. I thrive when
met with a challenge and can efficiently use my critical thinking
skills to ensure resolution. I strive to exceed expectations by
producing quality while maintaining quantity of work.
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PROFESSIONAL EXPERIENCE
PRA HealthSciences, Marlton, NJ
Director of Regulatory Affairs
2/2009 - Present
Oversee regulatory departments at two locations
Mange ?7 regulatory associates
Overseeing and leading team members
Serve as a resource/mentor to coordinators and nurses
Interview/hire new staff as applicable, complete annual reviews,
orient/train new team members
Conduct in-house audits of clinical studies and ensure they are audit-
ready for Sponsor and/or FDA
Oversee/complete Initial submission and maintenance of all regulatory
documents for 800+ Clinical Trials
Review all protocols, trial conduct as well as monitoring of selected
completed source documents
Create and Revise Standard Operating Procedures and Work Instructions
Develop Informed Consent documents
Complete and Review Corrective Action/Preventive Action (CAPA)
Track Rater approvals
Ensure Raters are fully qualified
Work with vendors to ensure rater requirements, resources and
equipment is onsite to conduct ratings.
Assist in the development and revision of protocols
Interface with Sponsors and CROs on a daily basis
Interface with FDA
Ensure corporate policies and procedures are in full compliance with
regulatory requirements and are being adhered to internally
Ensure site is aware of any revised or new FDA regulations
Submit all essential documents including revisions to the Sponsor.,
CRO and IRB
Serve as a liaison between company personnel, corporate partners, and
regulatory agencies to keep projects on track
Create advertisements for trials and obtain sponsor and IRB approval
Responsible for off-site archival and retrieval of all study documents
upon study close out
Ensure clinical trials are conducted in compliance with the protocol,
GCP guidelines and FDA regulations
Conduct consent discussion and obtain informed consent as required
Assists in the preparation of 'Requests for Proposal' documents and
financial analysis of CRO proposal costs and negotiation
CRI Lifetree (formerly CRI Worldwide)
Regulatory Affairs Associate/Clinical Research Coordinator
2/2006 - 2/2009
Ensure corporate policies and procedures are in full compliance with
regulatory requirements and are being adhered to internally
complete Initial submission and maintenance of all regulatory documents for
800+ Clinical Trials Prepare and submit continuing reports to appropriate
regulatory agencies
Serve as a liaison between company personnel, corporate partners, and
regulatory agencies to keep projects on track
Facilitate periodic monitoring visits and interact with monitors and
auditors
Ensure timely completion/correction of source documents and CRFs
Perform data entry and verification of subject information for trials
involving electronic data capture
Conduct consent discussion and obtain informed consent
Maintain records for the receipt, dosing, administration and accountability
of investigational product
Verify and respond to queries
Law Offices of Raymond W. Ruthrauff & Associates P.C., Philadelphia, PA
Senior Legal Assistant
10/2004 - 2/2006
Report directly to two attorneys with broad ranged responsibilities that
encompass the timely preparation of cases from discovery to arbitration
phase
Coordinate multifaceted office functions encompassing court calendar
management, retention of court reporters and scheduling of deposition
proceedings
Liaise between attorneys, clients and insurance companies
Renal Care Group, Woodbury, NJ
Administrative Assistant
04/2003 - 10/2004
Responsible for data entry, scanning, filing
Communicate with patients, employees, and other individuals to provide
resolution to questions
Compile, copy, sort, and file records of office activities, and business
transactions
Lab Preparation
Enter, transcribe, record, store, or maintain information in written and
electronic/magnetic form
EDUCATION
Thomas Edison State College, Trenton, NJ
Bachelor of Arts with a Concentration in Psychology
Currently Enrolled
American Heart Association
2012-BCLS/CPR
DWD Associates
2012-GCP/ICH Training
Medical Research Management's Investigator Perspective FDA
2008- GCP/ICH Training Course
Camden County Community College, Blackwood, NJ
Associates of Science in Elementary Education
May 2003
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