Medical Clinical Research

RAGITHA.E

****-** ******* ***,

ETOBICOKE,ON M*A 4X6

MOBLIE: 416-***-****

yajniu@r.postjobfree.com

yajniu@r.postjobfree.com

OBJECTIVE

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I seek to make substantial contributions in the field of Clinical Research through commitment, competence, dedication and hard work for the growth of the organization and the benefit of mankind.

SUMMARY OF QUALIFICATIONS

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Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements

knowledge of clinical trial process

Experience in Phase II and III drug trial

Quality documentation and analytical skills

Familiar with medical terminology and practices

Extensive knowledge of human anatomy and physiology

Strong computer skills

PROFESSIONAL EXPERIENCE

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Kumarasamy Hospital ,India (02/06/2009-22/02/2012)

Clinical Research Coordinator

Responsible for understanding and compliance with Investigator Brochure, Study Protocol procedures, ICH-GCP, SOPs and regulatory requirements

Performed all study related procedures including Informed and Voluntary Consent, past medical history, vital signs, inclusion/exclusion criteria, completion of source documents and CRFs/eCRFs

Communicated, and maintained accurate correspondence records, with the sponsor, CRO, and internal personnel departments

Lab sample preparation and shipment

Took part in Site Initiation Visit, Site Selection and Site Monitoring

Collected medical data on study subjects

Handling, receipt, storage and dispensing of the Investigational Product.

Reported SAE and PSUR to the Ethics Committee and sponsor

Documentation of all trial-related information and correspondence.

PSG Medical College and Hospitals, India (05/02/2008 –10/ 02/2009)

Clinical Research Coordinator

Ensured compliance with protocol guidelines.

Assisted the Principle Investigator for trial related activities.

Maintenance of various logs like drug accountability, temperature, patient screening and enrollment etc.

Coordinated Screening, randomization, discontinuation, screen failure, drug dispensing through IWRS (Interactive web response system) etc.

Coordinated and performed follow-up visits according to trial protocols.

Reported AEs and SAEs according to industry and sponsor standards.

Coordinated the informed consent process and documented the process according to the standards.

Ensured compliance with the requirements of local ethics committee and compiling the necessary documentation for new study protocol submissions and ongoing studies

Interacted with the sponsor representatives in an accurate, efficient and professional manner.

EDUCATION

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Post Graduate Diploma in Clinical Research and Regulatory Affairs, Prince

Edward University, Canada (2007)

Master’s degree in Biotechnology, Bharathiar university, India (2007)

Bachelor’s degree in Zoology ,Kannur university, India (2005)

Diploma in Computer Application(M.S.Access, M.S. Excel, M.S. Power Point,

M.S.Word)

Statistical Software: SAS (Highbrow Technologies,India)

KEY SKILLS

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Excellent organizational, planning and problem solving abilities

Established interpersonal and communication skills

Able to work under optimal supervision

Pro-active, and have an eye for detail.

Work well in teams and able to coordinate and relate to others.

Working knowledge of laboratory techniques

MSc PROJECT WORK

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“Production of microbial surfactants by Pseudomonas spp. isolated from oil contaminated soil”

WORKSHOP/TRAINING PROGRAMMES ATTENDED

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IPR and Patents by Adv.krishna Prasad Lecturer and copyright officer Edith cowen University, Perth West Australia.

clinical trial design and phases of clinical trial by Dr.J.R.Srinivas, ACEER, Chennai

Y schedule and Medical writing by Dr.Devan Parmar, Vice President, Wockhardt.

The Frontiers Of Dementia Care & Research by the Neurosciences India group & ARDSI at IIT, Madras.

Practical aspects of Clinical Research by Dr.ArunBhatt, Clininvent Research Pvt. Ltd.

Stem cell research, pharmacovigilance and clinical trials management by Dr. Ramananda Nadig, M.D (Pharmacology)

Biostatistics in clinical trials, Dr. Anil C. Mathew, Associate Professor, PSG Medical College, Coimbatore

REFERENCE________________________________________

Dr.J.S.Bhuvaneswaran, MBBS, MD,DM, Professor and Head of Department of Cardiology, PSG Medical college, Coimbatore, Tamilnadu.mobile: 098********

Dr.M.S.Vasanth,MD,Pediatrician,Kumarasamy Hospital,Tamilnadu,India,Mobile: 042*-*******

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