Professional  Summary:

Certified  and seasonal Clinical Research Professional with 6+years of clinical research  experience.

  Demonstrated  expertise is clinical site management including performing site visits,  negotiating budgets, authorizing ICF's and study manuals, maintaining trial  master file and Vendor management. Proficient in use of EDC,CTMS and IVRS  systems experienced in managing investigator site activities from study start  up through data base lock in Phase I,II and III in multiple therapy area  including Diabetes, Genetic disorder, Cardiology, Prostate cancer, Breast  cancer , Solid Tumor , Liquid Tumor, Arthritis, Gout, Leukemia, GI, ED,  Dyspepsia. 

Experience:

Clinical Study Coordinator III (Oncology)

  Confidential,  Phildalphia 6/11- 1/12


  
Conduct full clinical       research coordinator duties for assigned Trials

  
Review protocol for       budget cost analysis, in conjunction with CRG budget       group

  
Coordinates and       participates in the pre-site and site initiation visits

  
Coordinates study       initiation and assists with planning and design of source documents for       protocol. Adhere to study protocol

  
Assist with accurate       source documentation and appropriate forms as per protocol       on all participant record, Drug accountability, test devices and clinical       supplies

  
Compliance with all       CRG, HR, office of Compliance and any other working       departmental training

  
Working with NIH       trials including NSABP, RTOG's ECOG 

  
Work with cancer       Collaborative team 

  
Familiar with IRB       continuation report 

  
Conducting phase I       studies in Myeloma, Virus TB Vaccine from Celgene, Shingles Vaccine from       Merck 



Regional CRA II  2/10- 6/11 

  Confidential 


  
Conducted Independent       Monitoring sites.

  
Reviewed Protocols and       Amendments

  
Reviewed and approved       ICF. Revised ICF to confirm with site/local IRB requirements

  
Travel 30% 

  
Review site/study       budgets

  
Review and reconcile       Drug Accountability Log 

  
Close out visit report       review /Regulatory compliance review

  
Conduct Initiation       visit/start up and closeout visits 

  
Conduct phase II and       Phase III studies 

  
Regional liaison between specific project team       investigational sites, and sponsors 



Clinical Research associate II (In- house)

  Confidential, Raritan NJ (Contract)   1/10- 2/10 


  
Documents Specialist

  
Clinical Audit

  
Documentation of findings for Global       Country study files.

  
Study drug record Compliance for FDA       submission.

  
Conduct Phase I study for skin biopsy 

  
Conducting audits for international       trials for FDA /MHRA audit 



Senior  Clinical research associate 10/08-10/09

  Confidential, Cranbury NJ (Full Time)

  Studies: Genetic disorder  (Lysosome storage disorder) Pompe, (Protein misfolded) Fabry and Gauche 


  
Reviewed (regulatory       document) for site initiation and closeout Procedure

  
Reconciled and tracked       Adverse and Serious Adverse event

  
Attended team meetings       and teleconferences for capture deliverables

  
Monitored sites 

  
Authored study manuals

  
Design of CRFs and Source Documents according       to protocol details. 

  
Reviewed and approved       ICF. Revised ICF as necessary to conform with site/local IRB requirements

  
Created, updated and       reviewed protocol related study documents and study start-up Documents       (i.e. monitoring plan, training plan and recruitment plan.)

  
Direct contact for budget development and       negotiation at investigation site level 

  
Reviewed and       negotiated site/study budgets

  
Provide GCP/ICH compliance mentorship,       auditing and training to site and industry personnel. 

  
Reviewed study Listings       for accuracy

  
Managed 9 study sites       all over USA and including CRO,       vendor management like Central Lab, fisher Lab and shipping vendors

  
Trained CTA for 4       month to promote As a CRA role

  
Conducted Pre-study       site visits, initiation visits, interim monitoring visits, Pre- study       visits and close-out visits

  
Participation and presentation in       investigator meetings and recruitment of sites.

  
Provide consultation on site selection and       final recommendation. 

  
Managed and attend       meeting with Study vendors

  
Involved in conducting       Phases I to Phase III studies and have performed some Phase II studies

  
Proficient in EDC       system including Phase forward's INFORM 

  
Worked with I-Review 

  
Travel 30% to 40%

  
Involved in Drug       Development process (process ordering Drugs for site)

  
Worked in pre-trial       for Parkinson and Oncology (Tumors and Breast CA) 



Confidential,  East Brunswick NJ 3/07-8/08

  In-house CRA (Contract Position) 

  Study: PEG LOTICASE (GOUT)  TOPHI 


  
Review (regulatory       document) for site initiation and closeout

  
Reconcile and track       Serious Adverse event

  
Attend team meetings       and teleconferences 

  
Work with Vice       President of Clinical and Director of Clinical Research to review study       documents and drugs listings

  
Conduct patient data       listing review

  
Create and maintain       data tracking tables

  
Manage the ordering       and distribution of study related supplies

  
Review Protocols and       Amendments

  
Review and approve ICF

  
Create, update and       review protocol related study documents (i.e.ICFs, Visits Reports, etc.)

  
Review site/study       budgets 

  
Review data       /Bio-statistics documents

  
Manage appropriate       study documentation

  
Review Monitoring       visit report

  
Monitored 3 Infusion       sites in Philadelphia

  
Update and maintain       study specific tables that document protocol deviation/violation

  
Assists in the       recruitment of potential sites that meet protocol requirements

  
Review SAE and       Infusion reaction listings and physical examination listings for the       BLA(Biological License application)

  
Review vendors       contract invoices/payments 

  
Review and reconcile       Drug Accountability Log 

  
Conducting Phase I and       Transition to Phase II studies in Gout and Arthritis

  
Close out visit report       review /Regulatory compliance review 



Confidential, Princeton, NJ  4/06-3/07

  Clinical  Research Associate and Data Analyst

  Study: LUITPOLD Pharmaceuticals 


  
Conducted multiple       Clinical Studies for the Commercial and Government Sectors (NIH) in       Oncology (Leukemia, Solid Tumors, and Liquid Tumors) 

  
Involved in conducting       multiple Phases I to Phase III studies and have performed some Phase I       study and some Phase IV study

  
Conducted independent       monitoring visits

  
Conduct Initiation       visit/start up and closeout visits

  
Responsible for data       auditing and GCP compliance at study sites

  
Responsible for       auditing the Clinical Research Auditors

  
Reviewed SAE reporting       at sites

  
Accountable for       Pharmacy and Drugs for the studies

  
Worked with NCI/CTMS       for Government Sites for Only Oncology

  
Handled ten to       fourteen protocols at once and travel about 80% of the time

  
Familiar with       Regulatory Affairs and report writing

  
Handled and transcribe       queries

  
Conducted Clinical       Trials (Clinical Trial Management Service) for the NIH

  
Worked in CCOP Trials

  
Handled COOP       monitoring

  
Managed and train Junior       Level Clinical Research Associates

  
Worked with Health of       Canada as a FDA auditor

  
Worked as a head of       the team in FDA Auditors group



Confidential, Hamilton, NJ  2/04-6/06

  Clinical  Research Manager/Clinical Research Coordinator


  
Collected histories from patients including vital sign checks and chart  preparation

  
Performed EKG and Ultrasound testing

  
Handled front desk reception and office administration

  
Reviewed and administered insurance claims in accordance with medical  regulations

  
Conducted Diabetes and Oncology Clinical Trial

  
Worked In Prostate CA, Breast CA, Intestinal Carcinoma and Lung CA

  
Conducted phase I and phase II trials

  
Created Regulatory Binders/1572 forms

  
Knowledge of E trials software

  
Was in charge of GCP for the company

  
Handled Regulatory Affairs for the company

  
Worked with IBRS and Central Lab IRB


Confidential, 11/02-2/04

  Medical  Assistant (Part Time)


  
Collected patients' histories checked vital signs and handled chart  preparation

  
Handled medical billing

  
Prepared paperwork for insurance billing

  
Used Doctors Office Management System software (DOMS)

  
Performed front desk reception, made appointments and handled office  administration


Confidential, 3/98-12/01

  Vascular  Technician (Part Time)


  
Performed vascular testing for lower and upper extremities

  
Collected patient information and medical histories

  
Prepared paperwork for insurance billing

  
Assisted in office administration

  
Responsible for training of Junior and new entrants


Confidential, 3/98-12/01

  Neuro  Technician (Part Time)


  
Performed neurological tests for lower extremities (Tibial, Sural,  Peroneal, Motor and Sensory Nerves)

  
Collected patients' information and medical histories

  
Prepared paperwork for billing

  
Assisted in office administration


Confidential, Hyderabad, Pakistan 1/92-5/93

Instructor, Biology, Mathematics and General Science

CERTIFICATIONS/EDUCATION

Certified  CCRP (SOCRA) 2007

  EDC  Certified  2009

  Certified  EKG Technician  1997

  Barnett Educational Services  2009

  National  Healthcare Association  1997

  Complete GCP training 2009

  Ultrasound  Technician Training 1998

Bachelor  of Science, Biology