Clinical Research Manager

OBJECTIVE

To obtain a Permanent or Contract Clinical Research position in

Pharmaceutical industry

SUMMARY

. 5 yrs of Clinical Research Experience in Pharmaceutical &Medical

Device industries

. Therapeutic Areas: Oncology, Dermatology, Psychiatry, Respiratory,

Cardiovascular, Gastroenterology: Clinical Trial Phases: II, III, IV

. Experienced with in-house & on-site monitoring, protocol & EDC

training, revision of source documents & eCRFs, regulatory documents,

patient enrollment/recruitment activities, clinical study data, vendor

payments, ICFs, IRB approvals, TMF, shipment of study material,

validation of instruments, patient testing, various databases.

. Knowledge of Medical Terminology & GCP guidelines

. Travel up to 50% or as required

EDUCATION

BA - Concentration in Natural Sciences, Rider University, New Jersey,

2002

EXPERIENCE

Johnson & Johnson New Jersey

01/10-02/10: Clinical Research Associate II (In-house)

. Perform audit of trial master files (TMF) & Pharmacy Files for 3 Phase

III international studies for FDA

. Reconcile file content versus required content

. Provide summary of discrepancies

. Work with CRO to collect and track outstanding essential documents

Xtrials (CRO)

New Jersey

08/09-11/09: Clinical Research Associate (In-house & On-site)

In-house and On-Site Monitoring of clinical trials based in

GastroEnterology

. Act as a main liaison between Investigators and Sponsor

. Conduct Initiation and Monitoring visits for assigned sites

. Provide Protocol and EDC trainings to investigators and study staff

. Ensure investigators follow approved protocol and other regulatory

requirements

. Verify signed consent forms & exclusion/ inclusion criteria for

subjects enrolled

. Determine SAEs and deviations are appropriately documented & reported

as required

. Check the completeness and accuracy of CRF/EDC against source

documents

. Perform study product accountability and verify storage requirements

. Review study files for current protocol, ICF, IB & other essential

documents

. Discuss all issues and observations with investigator & take proper

action

. Prepare the site visit reports and site confirmation/follow up visit

letters

. Follow up with sites for patient recruitment/enrollment activities

. Keep close contact with sites to ensure the proper data entry &

adherence to GCP

. Attend weekly teleconference and take meeting minutes

. Document and communicate study site progress and issues/concerns w/

the project team

. Coordinate with sites for data queries resolution, maintain TMF

Johnson & Johnson New Jersey

3/07-3/09: Clinical Research Associate I

Responsible for in-house site management and coordination of Oncology,

Dermatology, Psychiatry, Respiratory studies

. Preparation, Collection and Revision of regulatory documents for

accuracy and completeness at study start up, interim and close out

. Distribute and track Confidential Agreements and Investigator

feasibility questionnaires

. Assist with site selection by checking the healthcare databases

. Communicate with sites on document updates and corrections

. Liaise with Site Managers (SM) on trial documents and study site

readiness

. Partner with LTM to ensure overall site management

. Detailed review of site specific Informed Consent Forms (ICFs)

. Receive, Review and transmit the IRB approvals

. Prepare and update Appendix 1.4.1 for Financial Disclosure Reports in

CTT

. Maintain and prepare trial master file documents for reconciliation,

archiving & auditing

. Create, Update and ensure accuracy of sites in CTMS.

. Maintain and update CTSRS contact information to ensure appropriate

SAEs distribution

. Create virtual documents in GRIPS for purposes of FDA 1572/CV scanning

. Utilize AGORA for protocol inconsistencies

. Attend Investigator Meetings as required

International Technidyne Corp.

New Jersey

8/04-3/07: Clinical Research Coordinator

Managed different aspects of CardioVascular clinical trials:

. Assist with in-house monitoring of clinical studies

. Involved in testing on in house clinic patients treated with

anticoagulation drugs

. Perform validation testing on the blood monitors

. Assist with preparation and execution of protocols, ICFs, OP manuals

and CRFs

. Assist with revision of CRFs and recruitment activities

. Follow up regularly with study coordinators and patients self testers

for study updates

. Collect, review, and record clinical study data

. Provide technical support and product training

. Coordinate shipment of study materials and process vendor payments

. Assist with the development of Abstracts and Manuscripts

. Search and obtain literature references and maintain library

TECHNICAL SKILLS

Operating Systems: WindowsXP/NT/2000/98/95

Software Packages: MS Word, Excel, PowerPoint, Rational Test Manager,

End

Note, Electronic Data Capture (EDC), Clinical Trial

Management System (CTMS), Electronic Trial Master File

(eTMF), Clinical Trial Safety Reporting System (CTSRS),

Global Research Information and Publishing System

(GRIPS), Clinical Trials Tracking Reporting Tool (CTT),

AGORA

REFERENCES: Furnished upon request

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