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Clinical Research Assistant

Location:
New York, NY
Posted:
November 21, 2014

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Resume:

MERIN ELIZABETH ABRAHAM

acgsy0@r.postjobfree.com

Mobile: 201-***-****

A dynamic Professional with 3 years of experience in clinical trials and

pharmaceutical industry. Strong interpersonal skills, team player and fast

learner. Ready to start a new career in clinical research.

CAREER HIGHLIGHTS:

1.St. Johns Research Institute, Bangalore. Feb '11 to Oct '13

Clinical Research Assistant

> Coordinating with multiple sites for various trial related activities.

> Reporting events to the regulatory, sponsor and Ethics committee

within the timeline.

> Monitoring the data quality of site data in e-crf and resolving the

issues faced at the site.

> Coordinate all lab related activities with local and central labs-

shipment of samples through the designated courier and ensure timely

receipt & filing of the lab reports.

> Maintain the study related logs - screening, enrolment and other

communication logs.

> Assist in the process of site selection and collecting regulatory

documents and submitting to regulatory.

> Report to Principal Investigator and co ordinate in subject's trial

related activities.

> Complete the Case Report Forms within the timelines and minimal

errors, resolve data queries (DCFs) arising from the CRFs'.

> Manage the accountability of the Clinical Trial Material at the site.

> Keep a track of and maintain all source documents related to the

patient / subject.

> Assist in the process of Recruitment, administering informed consent

to potential patients and discussing in detail the patient information

sheet and Retention of the patients as well.

2.Himalaya Drug Company, India. March 2010 to June 2010

Clinical Research coordinator

> Worked as a Trainee in the Documentation, and Publication Department,

Clinical Pharmacology, Himalaya Drug Company, Bangalore, India as a

Clinical Research Coordinator from the period of March 2010 to June

2010 (3 months). I have hands on experience in the preparation of the

following documents:

> Protocols involved in Clinical Trials

> Investigator Brochures (IB)

> Clinical Study Reports (CSR)

> Inform Consent Document

> Case Report Form (CRF)

> Product Profile

> Common Technical Document (CTD)

PROJECTS UNDERTAKEN

. Clinical Research Projects :

> A large, international, placebo-controlled, factorial trial to

assess the impact of clonidine and acetyl-salicylic acid (ASA) in

patients undergoing non cardiac surgery who are at risk of a

perioperative cardiovascular event.

> A randomized double-blind placebo-controlled trial for the

evaluation of a polypill, a low dose aspirin and vitamin D

supplementation in a primary prevention setting to reduce

cardiovascular disease (CVD) outcomes - The International polycap

Study 3.

> A large multicenter international cohort study evaluating major

vascular events in patients undergoing non cardiac surgery.

> A Situational Analysis of the attitudes, practices and perceived

barriers by physicians and patients for the treatment of

cardiovascular diseases across India.

> An observational prospective study of practice patterns and

outcomes in chronic disease in urban family practice in Bangalore.

TRAININGS UNDERGONE:

> Training on "ORACLE RDC" as a part of the P.G. Diploma Curriculum.

> Project on "Synthesis and activity studies of de-novo designed

antimicrobial peptides" at Rajiv Gandhi Centre for Biotechnology,

> Project on "Maintenance of Cervical Cell line SiHa and Primary

Fibroblast Culture"

> Underwent three month (April 2008- July 2008) training on

"Programming using C and C++" at school of management and computer

science.

TECHNICAL KNOWLEDGE:

SAS Products : SAS/BASE, SAS/MACROS, SAS/SQL,

SAS/STAT, SAS/ODS,

SAS/ACCESS [Data

Extraction; Manipulation; Management;

Analytics & Reporting]

Languages : SAS, SQL, HTML.

Tools : MS Office - Excel,

PowerPoint, Word, Outlook

Databases : Oracle, SQL Server,

Operating Systems : Windows 95/98/ XP, MS-DOS

QUALIFICATION HIGHLIGHTS

2010 P.G Diploma in Clinical Research from Lotus Clinical Research

Academy, Bangalore, India..

2008 B-Tech Biotechnology, Sathyabama University, Chennai, India and

secured 77%.

PERSONAL DETAILS

Gender : Female

Date of Birth : 5th April 1987

Marital status : Married.

Languages known : English, Malayalam, Tamil

Address: :Apt :9A, 60 south main street, lodi-07644,NJ.

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HIGHLIGHT



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