Project Manager Quality Assurance

OBJECTIVE:

To obtain a challenging medical research opportunity where I can

effectively utilize my qualifications and skills while offering several

opportunities to integrate personal enrichment with professional goals

EDUCATION:

Passed CCRP Exam in Nov 2009 (Society of Clinical Research Association)

Post Graduate Diploma in Clinical Research from ICRI (New Delhi, India)

in 2008

B.Sc (Zoology Hons.) from Indira Gandhi National Open University (New

Delhi, India) in 2007

Diploma in Medical Laboratory Technology from Y.W.C.A. (New Delhi,

India) in 2004

PUBLICATION:

Adverse Events Associated with Testosterone Administration in New

England Journal of Medicine published on June 30, 2010

COMPUTER SKILLS:

Microsoft Word, Excel, PowerPoint, Access, FrontPage, Stata and S-Plus

TRAINING/CERTIFICATION:

. Trained in ICH GCP in April 2009 and April 2010

. Trained in IATA in June 2008 and July 2010

. Effectively complied with various audits by sponsor (BIRELY) and CRO

(Quintiles and Clinivent) and inspection requests by USFDA and DCGI in

September 2008

. Certified in "Understanding FDA and the FDA approval Process" in March

2008

. Trained in Wet Laboratory Flow Cytometery on BD FACS Calibur in October

2006

SUMMARY OF EXPERIENCE

Clinical Site Procedure Manuals:

. Experience with developing informed consent, Investigator Manual,

brochures, Request for Proposal, Protocol,

Case Report Forms and Image Acquisition Guidelines

. Experience in preparing Site Manual for Data Collection & submission

and adverse event reporting procedures

Clinical Research:

. Experience with Oncology, Cardiovascular,Central Nervous System,

Nephrology and Endocrinology clinical trials

. Experience with clinical sites visits as a CRO

. Experience with site initiation following protocols

. Experienced in clinical trial operations having three years in

pharmaceutical proficiency in managing and executing various phases and

aspects of clinical trials in therapeutic areas such as but not limited

to Bone, Oncology, and Hemophilia in accordance with ICH / GCP

guidelines and SOPs

. Experience with preparing study plan which included clinical site

enrollment following research protocol

. Working Knowledge of FDA Regulations, IRB guidelines for submission of

clinical study involving human subject.

. Working Knowledge of CFR 21 part 11 of the federal regulation

. Knowledge of all the stages of study activities and experience in

communicating details to ensure that all team members are kept informed

and aware of action items that will impact their tasks

. Experience in clinical trial monitoring activities (qualification,

initiation, routine monitoring, close-out and reconciliation)

. Experience in writing monitoring reports and presenting findings to

project PI/PD

. Experience in training of Site personnel in clinical trial methods to

ensure protocol compliance

. Experience in editing and formatting Protocols and Reports and assisting

in the design and development of case report forms and creation of study-

specific Informed Consent

Adverse Events:

. Experience in reporting any serious adverse event during visit to a

clinical site

. Experience in reporting and reviewing Adverse Events

. Experience in reporting any adverse drug reaction which is serious and

unexpected

. Experience in coding adverse events using the standardized Med-DRA

dictionary

. Experience in ADEERS for reporting Adverse Events

. Knowledge of Common Toxicology- Terminology Criteria for grading an

adverse event in relation to the drug

. Knowledge of reporting mechanism and reporting summary for an adverse

event

. Experience in conducting medical review of Adverse events

Study Protocols and Design:

. Experience in operational aspects of clinical trial activities (Phase I

through IV) and clinical program activities

. Experience in development of specific sections of clinical trial

protocols based on the study design and related documents

. Experience in development of study tools including guidelines and

training materials for study sites and investigators

. Experience in implementing issue resolution plans

. Experience in developing publications, abstracts, presentations, and or

clinical sections of regulatory documents

EXPERIENCE:

Nov 2009 - Jul 2010

Boston Medical Centre

Clinical Research Coordinator - (Department of

Endocrinology)

. Worked on NIH and industry funded studies on the effects of testosterone

on multiple aspects of health and physiology including muscle function,

body composition, and sexual function

. Excellent knowledge of ICH GCP, HIPAA regulations, ethical guidelines,

IATA etc. and ensured compliance with protocol related procedures and

requirements

. Excellent understanding of 21 CFR 11,50,56,312,812,45 CFR 46, Health

Canada, ICH GCP E2, good clinical practices (GCPs) & SOPs

. Coordinated day-to-day study operations including telephone contact with

subjects, scheduling appointments, recruitment of subjects, patient's

visits & further follow-up subject's visits

. Communicated with investigators, clinical monitors, statisticians, staff

of collaborating research sites and colleagues to ensure effective

clinical trial implementation

. Initiated and maintained required clinical and regulatory files

. Ensured patient's safety & protection by continuously monitoring

patients for any AE and SAE and maintained confidentiality with regard

to patient information and other sensitive information

. Implemented research protocols including submission of protocols and

consent forms to the IRB

. Maintained clear, concise, accurate and legible records, budgetary

information, regulatory documents, inventories and ordered equipment

& supplies

. Developed and implemented measures to improve efficiency in office

operations and also assisted in developing and implementing quality

control (QC) procedures

. Efficiently compiled and maintained a database related to the study and

performed data cleaning procedures

. Prepared slides and gave presentations to the clinical research staff

including directors & sub investigators related to regulatory binder

contents and ICH -GCP guidelines for AE & SAE

Feb 2006 - Jun 2009

Sir Ganga Ram Hospital

Senior Clinical Research Associate - (Department of

Cardiology and Nephrology)

. Effectively managed phase II, III trial in AF- Thrombosis, Type I

-Diabetes Mellitus, Acute Coronary Syndrome, Left Ventricular Heart

Failure, Coronary artery disease

. Implemented research protocols including submission of protocols,

consent forms & other study related documents to all the sites and to

their respective Institutional Review Board (IRB)

. Handled study qualification assessment, study feasibility, study

document translation & study site monitoring

. Efficiently organized study and trial master file and monitored &

reported protocol deviations & resolved issues

. Prepared & reviewed Serious Adverse Event reports and collected,

reviewed & verified safety data

. Resolved queries of CRF data with study site personnel and confirmed

quality problems & consenting procedures and coordinated EC submissions

. Ensured the accuracy and completeness of site regulatory documentation

including device accountability records, ethics committee approvals &

reports and adverse event documentation

. Conducted site initiation, monitoring and close out visits

. Trained site staff on study related aspects & GCP and maintained IP and

study material accountability

. Worked with Clinical Project Manager to collect relevant study

information on timelines, progress and resources

. Attended and participated in various meetings with the staff, doctors

and regulatory bodies

. Evaluated flow sheets and study forms for completeness, accuracy in

compliance with protocol requirements and adherence to protocol

treatment plan

. Monitored activities at clinical study sites to assure adherence to Good

Clinical Practices (GCPs), SOPs, and study protocols

. Created various trackers for project planning, recruitment and project

status for multiple projects in MS Project

Oct 2005 - Jan 2006

Zoetic Health Care Pvt. Ltd

Blood Bank- Lab Technologist

. Trained Laboratory staff about sample collection, pre-analysis & post-

analysis procedures of blood sample process and gave demonstration about

the ELISA

. Performed live blood collection in Blood Bank & Laboratory, guided and

motivated the sales team about new products for blood collection

. Performed qualitative and quantitative laboratory tests on patient

specimens according to established standards and practices

. Analyzed test results and prepared samples for testing

. Maintained test findings & records in the database

Sep 2004 - Sep 2005

Cryobanks International India Pvt. Ltd

Research Associate

. Analyzed and proliferated HPC-C CD34+ stem cells in umbilical cord and

umbilical cord blood and performed viability of stem cells and ELISA

. Developed a specialized culture in microbiology lab, performed blood

grouping and blood counting & cryo-preserved the stem cells and followed

GLP guidelines

. Assisted in laboratory compliance requirements and was responsible for

implementing quality control and quality assurance procedures

Contact this candidate