Manager Management

E l s e E. M. H a g e l i n

** ******* ****, **********, *** Jersey 07921; 908-***-**** (C); email:

*******@***.***

WORK EXPERIENCE

Global Clinical Operations, Raritan, NJ

Division of Janssen Research and Development, LLC

Contract Investigator Document Associate, 1/2011 - Present

. Responsibilities included but are not limited to the following:

o Provide clinical research support and assistance in overseeing

the conduct of clinical trials at the sites; to evaluate,

monitor (in-house), and document the study progress

o Ensure that trials adhere to study protocols, applicable SOPs,

FDA regulations, International Conference for

Harmonization/Good Clinical Practices guidelines, and other

government regulations

o Prepare study start-up materials and the Trial Center File

binders with regulatory documents then distribute to the sites

o Liaise with investigator site personnel on a daily basis to give

advice and to collect completed regulatory documents

o Ensure completion of site specific regulatory documents for the

submission and approval by the IRB at the start-up of the study

o Collaborate with Local Trial Manager and J&J legal team to

ensure that the site specific ICF documents meet Sponsor, FDA,

ICH and HIPAA requirements, and are acceptable for the IRB

submission

o Collect and review regulatory documents for accuracy and

completeness and have those corrected when required; track on a

spreadsheet and upload in eTMF

o Issue updated study documents (e.g. protocol amendments,

updated IBs, revised ICFs) to sites as required and ensure their

submission and approval by the IRB

o Check IRB registration status; track results on a spreadsheet

o Collaborate with CGA on Legal language of CDA as needed; ensure

CDA and Feasibility Questionnaire are sent to sites and

completed then obtained from sites

o Check potential investigators for possible debarment before the

final selection of the site; at the start of the study to check

all staff listed on 1572 for debarment; track results on a

spreadsheet

o Follow up with the site proactively until all regulatory

documents are received and approved for submission then obtain

stamped IRB approved documents for filing in IF

o Add selected sites to the CTMS and CTSRS database as required;

track financial disclosures and IRB dates in CTMS as required

Gr nenthal USA, Inc., Bedminster, NJ

Clinical Trial Assistant, 1/2010 - 12/2010

. Responsibilities included but were not limited to the following:

o Managed Trial Master File (TMF) and filed documents in timely

manner

o Performed consistency checks of Trial Master File (TMF)

o Tracked investigational product (IP) kit shipments and

distribution to the investigators

o Ensured trial equipment distribution to the sites by vendors

o Supported in tracking, controlling and reporting of clinical

trial status

o Supported in timely generation, review and revision of all trial

management data

o Uploaded clinical and regulatory documents into electronic

management system from IRB site and internal databases

o Supported in quality control activities of US Development

Operations

o Participated in TMF internal audits; provided responses to

findings as required with the CSM

o Created memorandums as required for clarification of any

unresolved issues

o Corresponded with QA on issues pertaining to TMF documentation

o Created a report on CAPA training participation

Global Clinical Operations, Bridgewater, NJ

Division of Johnson & Johnson Pharmaceutical Research & Development, LLC

Contract Investigator Document Associate, 10/2008 - 12/2009

. Responsibilities included but were not limited to the following:

o Collected site documents and reviewed of regulatory documents

such as 1572s, CVs, financial disclosures and investigator

signature pages for accuracy and completeness at study start up

as well as throughout study

o Reviewed the exclusion databases for debarment of investigators

at study startups and of any new investigator added on the

updated 1572s

o Initiated and tracked Confidential Disclosure Agreements (CDA)

and Feasibility Questionnaires (FQ) and ensured the receipt of

CDAs and FQs by due diligence follow up with Investigators

o Negotiated the contract language of the CDA with site as

required

o Interacted with and provided support to Local Trial Manager

(LTM)

o Assembled the study startup materials and Trial Center File

(TCF) binders with regulatory documents and distributed to the

selected Investigators for the study participation

o Processed, tracked and distributed any amendments and/or updates

to such as Protocol, Investigator Brochure (IB) and/or ICF

o Reviewed the initial and updated site specific ICFs, negotiated

the language, e.g., for privacy and pregnancy sections, and

ensured that the required corrections were made to expedite the

document for IRB approval

o Prepared Appendix 1.4.1 for all participating sites in the study

o Initiated sites in Clinical Trial Management Systems (CTMS) and

tracked financial disclosure forms and the required IRB approval

dates

o Tracked status of documents to reflect receipt and approval

dates.

o Quality checked and reconciled Investigator Files; contacted

sites for missing documents as required

o Managed Investigator Files and filed documents in timely manner

Sanofi-Aventis, Bridgewater, NJ

U.S. Medical Affairs - Internal Medicines

Contract Clinical Trial Coordinator, 2/2008 - 10/2008

. Responsibilities included but were not limited to the following:

o Supported the Clinical Trial Management team by interfacing with

various departments within U.S. Medical Affairs, including Legal

and Quality Assurance, to ensure for all required study related

documents to be retrieved and filed as required in Trial Master

File

o Worked with Clinical Trial Manager (CTM) to organize and track

all study related financial documentation

o Managed the set-up, maintenance and archival of the Trial Master

File (TMF)

o Cross-referenced electronic regulatory documents against paper

TMF; contacted investigators to retrieve any missing

documentation when applicable

o Submitted protocol deviations/violations and SAEs to

Institutional Review Board (IRB) as required.

o Created timelines for drafting and writing the Clinical Study

Report (CSR)

o Quality checked and rewrote Corrective Action and Preventative

Action Plan (CAPA) report for GCP non-compliance sites and

created CAPA slides for a Clinical Trial Manager

o Participated in preparation of TMF for an external audit

o Filed study related documentation in a timely manner

Pfizer Inc., Peapack, NJ

Contract Regulatory Authorization Notification Coordinator, 9/2006 - 2/2008

. Responsibilities included but were not limited to the following:

o For the Global Change Management processed Regulatory

Authorization Notifications (RANs) for such as legal entity

and/or production changes by quality checking, coordinating and

routing the change requests to local Regulatory Authority (RA)

contacts in affected international markets

o Carried out the follow-up with due diligence on any late

notifications as required

o Kept record of RAN processes by tracking status of all stages in

the routing processes and by uploading and saving documents in

appropriate databases including Documentum

o Assisted the Change Management, Manufacturing Sites and

Regulatory Authority contacts as required by investigating and

locating required documents; and by problem solving and

correcting any issue associated with the notifications as

required

Pfizer Inc., Morris Plains, NJ

Contract Records Management Assistant, 4/2005 - 7/2006

. Responsibilities included but were not limited to the following:

o Carried out general records management duties in accordance with

Standard Operating Procedures (SOP) by processing clinical study

records, including but not limited to tracking, reviewing,

quality checking and filing

o Reviewing and tracking of Case Report Forms (CRF) and Trial

Master Files (TMF); the documents included such as Institutional

Review Board/ Independent Ethics Committee (IRB/IEC) reviews,

approvals and membership lists, FDA 1572s, Informed Consent

Forms (ICF), Curriculum Vitae (CV), Diary Cards, Investigator

Brochures and Protocols for different Phases in clinical trials

o Conducted quality control checks of documents and documentation

processes by identifying errors, inconsistencies and

discrepancies, and correcting as applicable

o Organized and filed the regulatory records of Investigational

New Drug (IND) and New Drug Application (NDA) in regulatory

library

o Worked with and assisted Clinical teams by locating and

providing the required documents

Johnson & Johnson, Skillman, NJ

Contract Records Management Assistant, 9/2004 - 12/2004

. Responsibilities included but were not limited to the following:

o Supported and assisted in various Records Management duties in

organizing the clinical records

o Performed general documentation tasks including but not limited

to, data entry, organizing, filing, scanning and creating PDF

documents, and e-filing of the records

L.E.A.R.N. Associates, Inc., Liberty Corner, NJ

Office Administrator (part time), 7/2004 - 8/2004

. Responsibilities included but were not limited to the following:

o Part time office administrator in language school

o Performed tasks including but not limited to, general office

administration, bookkeeping by using QuickBooks Pro, Class

registration by utilizing Outlook and acting as a customer

liaison

SKILLS

General

Capable of analytical thinking, problem solving, verbal and written

communication, organizing and multitasking; proficient with details;

methodical, meticulous, insightful, observant; resourceful, assertive,

efficient and productive; capable of working independently and/or in a

team; dependable, versatile, flexible and fast learner. Bi-lingual

Software

Microsoft Office: Word, Excel, Outlook, Explorer, PowerPoint and Publisher;

SharePoint, CTMS, CTSRS, eTMF, Documentum

EDUCATION

Kean University, Union, NJ

Received Master of Arts Degree in Psychology, 2006, part time; GPA 3.86

Received Bachelor of Arts Degree in Psychology, 1997, part time; Summa cum

Laude, GPA: 3.94

County College of Morris, Randolph, NJ

Received Associate of Arts Degree in Social Science, 1993, part time; High

Honors

Received Certificate in Computer Aided Design with Merit, 1990, part time

Other Education and Training

Received two-day CAPA training by International Pharmaceutical Academy

(IPA), Boston, MA, June 2010

Attended 8 hour Seminar for Excel at Morristown Memorial Hospital,

Morristown, NJ, 2004

Attended 8 hour Seminar for PowerPoint at Tecknit, Inc., Cranford, NJ, 2001

Received Paralegal Certificate from Fairleigh Dickinson University,

Madison, NJ, 1997

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