Quality Assurance Management

HETAL SHAH

fsqso4@r.postjobfree.com Cell: 848-***-****

*** ******* *****, *********** ** 07751

Objective

Seeking a position in the clinical research field to assist and increase the level of productivity and efficiency of the company as well as merge into a dynamic globally focused organization that will strategically utilize my Clinical Research credentials while providing opportunities to integrate personal enrichment and professional goals.

Summary of Qualifications

• More than 6 years of experience in Pharmaceutical industry

• Background involves experience as a CRA, QA, and Scientist

• Currently supporting multiple projects as a regional CRA for Johnson & Johnson (New Brunswick), Wyeth (Jersey City, Florham Park), Dialysis Clinic (North Brunswick)

• Willingness to travel

Bachelors in Biology, Rutgers University, New Brunswick, NJ

Clinical Research Associate Certificate from Medical Research Management, an accredited provider Clinical Data Management from Kriger International Inc, Ongoing (Contract Research Organization)

Professional Experience

The Medicines Company Nov.2011 – May 2012

Clinical Trial Associate (CTA)

• Works closely with other team members as needed (Project managers, CRAs, CTCs, COLs, data management etc.)

• Worked with investigative sites to ensure completion and approval of regulatory package within a timeline set by clinical operation

• Worked with regional teams to ensure proper oversight of investigative sites during the entire course of the study

• Tracks study activities such as investigative site information, site activations, site performance and patient enrollment

• Ensured delivery of study related documents such as Protocols, Investigator Brochures or study aids to clinical sites

• Collected, reviewed and filed regulatory and other study related documents

• Performed final quality check of site visit reports before filing

• Assisted with the set up and coordination of meetings such as Investigators’ meeting, Coordinator Meetings, CRO Kick-off meetings, and regional site staff meetings

• Tracking and re-ordering clinical study supplies

• Created & maintained study contact lists

• Assisted in distributing, tracking, photocopying and filing of clinical trial documents

• Maintained communication with Regulatory and Data Management in regards to lab normals, PI CV, 1572 and the Electronic Signature Form

• Maintained and troubleshoot the website

• SUSAR and major document distribution (IBs, etc)

Amicus Therapeutics June 2011- Nov 2011

Clinical Trial Associate

• Supporting regulatory and project managers for global and domestic clinical trials

• Compiled and reviewed regulatory documents

• Track, file, maintain, and audit regulatory documents for Clinical TMF. Audit and maintain TMF including discrepancy follow-up and generation of notes to file as appropriate

• Coordinated investigators meetings

• Distributed trial Related materials to investigator sites

• Maintain Study and/or department Trackers (this may include, but is not limited to patient tracking, study visits, site recruitment, CRFs, CDA status, Potential Investigator List, and others as requested)

• Design, modify and implement study management tools

• Compile and review regulatory documents

• Assemble/distribute regulatory packages (as well as Confidentiality Agreements and Clinical Trial Agreements)

• Track, file, maintain and audit regulatory documents for the clinical TMF Audit and maintain TMF including discrepancy follow-up and generation of Notes-to-File, as appropriate

• Coordinate project payments (Investigator and/or vendor) by liaising with Accounts Payable and vendors, as appropriate

• Organization and coordination of internal and external meetings (this includes taking minutes/preparing agendas and/or meeting planning)

• Coordinate Investigators Meetings planning and logistics Attend all study related trainings to ensure complete understanding of clinical trial and supporting processes; as requested

• Secure and distribute trial-related materials to Investigator sites (e.g. laboratory kits, laboratory equipment, study file notebooks, etc)

• Prepare correspondence/memos/newsletters and distribute

• Other tasks as delegated by team leader including co-monitoring, on-site investigator file notebook reconciliation, drug accountability, etc

• Oversee the Patient Travel Policy and act as primary contact with dedicated Travel Agency

Kriger International January 2011- April 2011

Clinical Research/ Intern

• Performed various duties as member of clinical development team

• Designed CRFs and sent draft CRFs for review

• Planned investigator meetings: Provided scheduling support to Sr. Level Team Members

• Prepared set up logs

• Participated in development of informed consent forms and prepared letters of agreement/contracts

• Created checklist for initiation visits, periodic visits, and close up visits

• Prepared final study reports using template

ITC and Nexus DX December 2010- April 2010

Quality Assurance/ Record Management

• Scanning of DHRs

• Inventory of the DHR

• Generate case by case work order for all repairs and loaner

• Log repairs into cases, enter work order data

Johnson &Johnson, Wyeth, Dialysis Clinic, Diabetic Clinic June 2009- Sept. 2011

Shadowing/Assisting a Regional CRA (Part-time once a month)

• Conducted site monitoring

• Experience with reviewing documentation

• Knowledge of medicinal product (device, drug, biologic) research and development process

• Identified and reported non-serious and serious adverse events and checked whether SAEs were reported to sponsor. Assisted the study coordinator in correctly reporting the AEs to minimize discrepancies during the SAE Reconciliation process. Sent queries to clarify any missing or incorrect information to ensure that all adverse event information is accurately reported

• Knowledgeable of the clinical database vs. the drug safety database SAE Reconciliation process

• Applied principles of data management and query resolution, protocol development, case report form design, and informed consent writing

• Filed and reviewed documents as needed for the Trial Master File

• Applied/used monitoring methods such as the three step monitoring method and Corrective Action and Preventive Action (CAPA) plans to resolve GCP non-compliance

• Monitored and resolved investigator file issues

• Wrote professional monitoring reports

• Prepared and reviewed case report forms and protocols

• Assisted in the review of CRFs and Informed Consent Documents

• Organized site documents and performed data entry of patient information

• Prepared and managed confidential disclosure documents and clinical trial agreements

• Interacted with contract research organizations (CROs) and other vendors

• Performed drug accountability and reconciled counts with CRF source data and dispensing logs

• Created checklist for initiation visits and subsequent periodic visits

ImClone System, a wholly-owned subsidiary of Eli Lilly and Company Dec. 2009-Mar. 2010

Clinical Associate

• Sorted and organized Development documentation created by Imclone personnel, corporate partners or CROs.

• Created file folders, labels and updated master index for Development documentation

• When required, assisted in the preparation of files to be moved to long term off-site storage

• Interacted with team members to ensure effective communication and coordination with work activities

• Supported customer request for Development Archive resource information

• Assisted with scanning of Development documentation

• Facilitated the maintenance of electronic systems by adding, editing, deleting and retrieving documents with various databases

• Learned and complied with department SOPs and WIs, as well as guidance’s, and regulations from Health Authorities

• Supported other special projects as needed

• Used an electronic document management system

• Scanned and archived CRF’s, Clinical Trial Agreements and Contracts, Site Contracts, Informed Consent Forms, Financial Disclosure Forms

Sun Pharmaceuticals Inc., Cranbury New Jersey 2008 to April 2009

Quality Assurance:

• Developed and conducted quality related training program.

• QC data reviewing, tracking, follow up, remediation and implementation of CAPAs, non-conformances, change controls, and various other related audit tasks.

• Prepare presentations as assigned.

• Actively involved during the company’s FDA Investigation which led to eventual cGMP manufacturing approval for the site

• Viewed/ Audited compliance documents, SOPs and validation protocols as assigned; Report findings to Development management as necessary

• Trained new personnel as required and develop and implement training programs in the regulatory requirements as requested

Chemist: 2007 - 2008

• Demonstrated good analytical skills and expertise working with HPLC, Dissolution, TOC, UV, IR, and Mass Spec

• Wrote and updated SOP’s and stability reports

• Reviewed analytical reports and analyst notebooks

• Handled the storage, inventory, destruction, and reconciliation of controlled substances as per DEA and company policies

• Analyzed raw materials, in-process samples and finished products

• Accountable for analysis of stability samples, raw materials, in-process samples and finished products

• Assisted in the preparation of the protocols, SOPS, Worksheets/template, draft CRFs, and template informed consent

• Maintained laboratory notebook with experiments detailed so as to ensure reliability and reproducibility

Lab-Technician: Internship

• Kept the general lab equipments in maintenance and did calibration of instruments

• Made dissolution medias, reagents, standards, buffers, test solutions, and mobile phase to the various analytical procedures and methods according to the USP

• Performed the quarterly, semi, and annual DEA reconciliation reports and troubleshoot with DEA inventory cards whenever needed

Skills

• Good clinical practices 21 CFR 312, 21 CFR 812 IDE, 21 CFR 50 Protection of Human Subjects, 21 CFR 56 IRB, 45 CFR 46, 21 CFR 54 Financial Disclosure by Clinical Investigators

• Good Privacy Practice HIPAA’s Research Provision, ICH

• Performed five mock site visits utilizing case studies including the development of CAPA plans and memo’s to file

• Program Examination and Competency Testing: (1) Comprehensive Course Examination to validate the e-learning, (2) FDA GCP & ICH GCP regulatory examination, and (3) Monitoring Competency testing identifying 80% of the deficiencies

• Expert knowledge of GLP, GCP, GMP

• Handling of Laboratory Data and other external data, and Electronic CRFs

• Expert knowledge of ICH GCP

• Reviewed data for inconsistencies and logical errors according to the Data Management Plan

• Detail Oriented

• A team player who works well under pressure and can multi-task

• Excellent organization skills

• Ability to work as team or independently

• Excellent time management, interpersonal and communication skills

• Proficient in Microsoft Word, Excel, Power Point

• Electronic Document Management System

Contact this candidate