Jessica Ortega

*** ******* **** ******** ** *****

856-***-****

acpmh0@r.postjobfree.com

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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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