Regulatory Professional
Resume:
Nancy M. La Rocco
Twin Lakes, WI 53181
262-***-**** (cell)
ddhtb1@r.postjobfree.com
CAREER SUMMARY
Skilled Administrative professional with over 20 years in the clinical research industry, with experience in regulatory compliance, clinical document management, research grants, GCP Guidelines, and FDA Regulations. Proven ability to streamline work processes resulting in increased productivity, while ensuring time critical compliance deadlines. Detail and results oriented with a reputation for accuracy and effective customer relations.
PROFESSIONAL EXPERIENCE
ABBOTT LABORATORIES - Abbott Park, IL 9/2010 - Present
Professional Support III
Data Entry into Regulatory database using the Liquent In-Sight Manager (TRACTs). Part of a major clean up within Abbott’s GPRA Department in which I have processed over 5,600 documents. Ensuring all submission documents to the FDA are logged and entered under the correct naming convention. This involves reading and understanding each document and having an overall understanding of FDA regulations surrounding the submission of INDs and NDAs. Acquired an understanding of the eDocs and eSFM electronic filing systems.
TAKEDA PHARMACEUTICALS N.A., INC. - Deerfield, IL 2003 - 6/2010
Research Grant Specialist
Contractor through Advanced Clinical Research through June, 2004. Provide direct support to the Associate Director, External Research Grants Department.
1 Process and review External Research Grant Applications through external website.
2 Maintained fiscal budget, drug supply and all regulatory updates for several therapeutic areas.
3 Provide training and support on website to Clinical Scientific Managers and Investigators regarding the submission process to ensure proper compliance.
PROTOCARE, INC. – Chicago, Illinois 1999 - 2003
Regulatory Manager – Protocare Development (2002-2003)
Contract Research Organization (CRO)
Provided strategic planning in collaboration with Project Managers to initiate study start-up. Managed metric tracking of regulatory documents for multi-site trials.
1 Participation on SOP Development Team relative to regulatory requirements, including staff training
2 Management of secured Master Files
3 Conducted quality control reviews on master files prior to data locks
4 Worked directly with Project Managers functioning as regulatory review of protocols, review of all regulatory documents, presented at PI meetings providing training surrounding applicable GCP's and ICH guidelines. Assisted Project Managers with site subject enrollment and data management
Regulatory Manager – Protocare Trials (1999-2002)
Site Management Organization (SMO)
Responsible for regulatory training relevant to new polices, procedures and regulations. Managed 10 direct reports.
1 Assisted in the development of procedure manuals utilized as a company-wide resource for training of regulatory personnel.
2 Maintained and coordinated metrics tracking reports
3 Maintained curriculum vitaes for 75+ physician/investigators and 150+ research coordinators
4 Developed informed consent template to use for numerous research studies
AFFILIATED RESEARCH CENTERS - Gurnee, Illinois 1997 - 1998
Site Management Organization (SMO)
Supervisor, Central Files
Responsible for maintaining research documents for 110 investigational sites in addition to being a member of companywide task force, which established procedures for new site assimilation and operation. Managed five direct reports.
1 Developed and reviewed department standard operating procedures
2 Implemented new fields in site database to tract training dates
3 Trained staff in FDA Regulations and GCP's pertinent to site’s needs
4 Developed work forms that offered comprehensive and consistent project accountability
5 Created, developed and led the first physician curriculum vitae (CV) tracking database. Developed a standardized CV template, which was a key tool to market physician's sites.
CHICAGO CENTER FOR CLINICAL RESEARCH
Chicago, Illinois
1990 - 1997
Regulatory Administrator
Responsible for ensuring all processes and regulations were being following in all areas of the company while Managing 3 direct reports
1 Developed an archiving system for storage of completed research studies. This entailed a review of each document/file to ensure that the entire study was auditable by the FDA
2 Increased productivity of study coordinators 10% by developing and conducting comprehensive training of GCP's and FDA regulations, which improved staff performance
3 Defined and automated data input and implemented a department process to ensure timely and accurate submission of quarterly IRB reports
4 Assisted with the completion of IND submissions
5 Functioned as the contact person for FDA site audits. Interfaced extensively with the FDA audit team
RUSH-PRESBYTERIAN-ST. LUKE'S MEDICAL CENTER
Chicago, Illinois 1984 - 1990
Executive Secretary, VP of Finance
Administrative Assistant, College of Nursing
EDUCATION
Morton Junior College 1980
Stickney, Illinois
Business/Science Courses (about 20-25 credit hours completed)
PROFESSIONAL ORGANIZATIONS
1999 Drug Information Association (DIA)
1997 Regulatory Affairs Professionals Society (RAPS)
1996-1999 Association of Clinical Professionals (ACP)
CONTINUING EDUCATION
2010 Internal GCP Training Abbott Park, Illinois
2001 "Investigator Training for Medical Research" Chicago, Illinois
University of Rochester Medical Center and
Western Institutional Review Board (WIRB)
1998 Attended the DIA Conference
1997 ACP's 21st Annual Educational Meeting Atlanta, Georgia
"Strengthening the Alliance" May 18-21, 1997
1994 “Successful Clinical Trial Management for CRA's" Conference Washington, D.C.
Sponsored by International Research (IIT)
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