Objective

To secure a responsible and challenging position assuming wider range of

responsibilities in Clinical Research Organisation,where I can utilize my

education experience and unique innovative abilities to contribute to the

best of my potential.

Work Experience

Six months experience as Clinical Research Coordinator at Bharti Hospital,

Karnal.

# Study Phase Indication Role

1 Randomized, open label, comparative III Type1 CRC

trial of safety and efficacy of Insulin Diabetes

analogues in Type1 diabetes

2 Randomized, double blind, multicentric, II Type2 CRC

parallel, placebo and active control, Diabetes

study on Type 2 Diabetes with Oral Anti

diabetic drug

3 Multi-center, open,uncontrolled Phase 3 III Contracepti CRC

study on an Oral Contraceptive ve

. On-Site Coordination of the overall conduct of the study to ensure

compliance with study management, protocol, SOPs, ICH-GCP & applicable

regulatory guidelines.

. Coordinating Ethics Committee submission, approval and queries.

. Assist in the process of administering the informed consent to

potential patients and Schedule subject visits as per the protocol to

ensure maximal subject compliance & retention.

. Coordinate all lab related activities - shipment of samples through

the designate courier and ensure timely receipt/ review/ filing of the

lab reports.

. Complete the Case Record Forms within the timelines and with minimal

errors.

. Worked with Monitors in completing of training of team at site

regarding GCP, Protocol, Safety Reporting, maintenance of essential

documents & regulatory documents such as Ethics Committee submission

and other regulatory requirements.

. Compile and update the Trial Master File.

. Maintain study related logs- screening, enrolment, drug

administration, temperature and other communication logs.

. Familiar with EDC system (eCRF- Medidata, Oracle)

. Responsible for the management of study materials and supplies -

distribution, ordering, tracking, storage, reconciliation and

destruction.

. Proven abilities in maintaining quality of study, conducting sponsor

audit and regulatory inspection.

Academic Profile

Post Graduate Institute of Clinical

Diploma in Advanced Research-ICRI 2012 64%

Clinical

Research(PGDACR)

Integrated MSc

Biotechnology (5yr H.N.B Garhwal University 2011 74%

program)

Senior School Seven Oaks School 2006 80%

Certificate ISC

Examination(12th)

Secondary School Seven Oaks School 2004 91%

Examination(10th) ICSE

Internship

. Institute of Cytology and Preventive Oncology (ICPO), Noida in

Bioinformatics,Under Dr. Subhash.M.Agarwal

. Two months (June 2010-July 2010)

. Assisted in creating a Cervical Cancer Database containing 594

oncogenes

Dissertation Project

Expression, purification and biochemical characterization of a P-loop

GTPase of Mycobacterium smegmatis

-Under Dr.Nisheeth Agrwal,Assistant Professior,Translational Health

Science & Technology Institute,Gurgaon

-The work was a great success and the manuscript "Functional

characterization of EngAMS, a P-loop GTPase of " Mycobacterium smegmatisis

" has been sent to PLoS ONE for publishing.

Interpersonal Skills & Strengths

. Conduct of Clinical Trial as per the ICH GCP, SOP's & Protocol

Specified guidelines.

. Clinical Data Management Flow Process, Validation process, Discrepancy

Management, Data Entry & Knowledge of Medical Dictionary.

. Conversant with schedule Y, ICH- GCP Guidelines & Clinical Trial

Methodology

. Pro-active and Efficient Team Player.

. Verbal and written communication skills with good presentation skills.

. A flexible attitude with respect to work assignments and new learning.

. Ability to manage multiple and varied tasks with enthusiasm and

prioritize workload with attention to detail.

Awards Seminar & Workshop

. National seminar on "Metabolic Networks and Drug Designing" in Banaras

Hindu University, Varanasi.

. Workshop on "Fisheries Conservation and Enhancement in Northern Hill

States"

Jointly organised by NBFGR, Lucknow,Acquatic Biodiversity Conservation

Society(Lucknow) and Department of Zoology and Biotechnology, HNB

Garhwal University, Srinagar, Garhwal.

. Attended lectures regarding status of fisheries in Uttarakhand and

approaches towards conservation especially molecular approaches to

taxonomy and conservation.

. Participated and Won in various debates and other competitions at

school and college level.

. Have actively participated in many Quizzes at interschool level.

. Secured Second position in School in Secondary Examination.

Personal Information

Date of birth: 19-July-1988

Father's Name: Mr. M.D.Pathak

Nationality: Indian

Languages known: English, Hindi

Marital Status: Unmarried

Permanent Address: 274, Sainik Colony, Kaulagarh, Dehradun-248195,

Uttarakhand

Declaration

I hereby certify that the information furnished above is authentic &

complete to the best of my knowledge & belief.

(VIBHA PATHAK)

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