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Clinical Research Assistant

Location:
Piscataway, NJ
Posted:
June 20, 2020

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Resume:

Resume

Omeeta Chirayu Shah

Ph. no: 908-***-****

Email: addyek@r.postjobfree.com

Address: ** * ********* **, *** 257Q, Edison, NJ 08837

Linkedin : https://www.linkedin.com/in/omeeta-shah-67808140

Educational Qualification

2002-’05 - Baccalaureate in Optometry, Lotus college of Optometry, Mumbai, Nasik University, India

July ‘05-’06 Internship At Ophthalmologist Clinics and Optician shops. ( Part of Academic)

August ’05 Training in “Low Vision Aids” at LVP Eye institute, Hyderabad, India.( Part of Academic)

Certification:

May 2020 Prescription drug Regulation, Cost and Access: Current Controversies in Context

Harvardx, USA.

Trainings for Clinical Trial

2009, online training in OC-RDC & GCP from Pfizer, India

2014, online training in GCP from Bio pharma Institute, USA.

SKILLS:

Clinical Skills as Optometrist:

Taking patient History and resolving their visual needs by prescribing glasses, contact lenses, Binocular Vision Theraphy.

Basic refraction and prescribing glasses, soft contact lens fitting as well as RGP fitting, scleral lens fitting and prescribing appropriate lenses.

Used to evaluate patient for LVA and prescribing various LVA along with counseling patient.

Treated kids for Amblyopia with patching and trigger exercise on synaptophore.

Well versed with diagnostic procedures like Dilated and Undilated Retinoscopy,

Lensometry and Hand Neutralization,

Contact and Noncontact Tonometry,

Slit Lamp Examination of Anterior Segment of eye,

Sac Syringing, IOL measurement, ultrasound sonography, Visual Field Testing.

Master in handling;

Fundus Camera for Fundus Photography Fluorescence & ICG angiography, OCT for Macula and Anterior chamber depth

Skills as Clinical Research Coordinator:

Sept 09-Sept10

•Coordinated a clinical trials conducted by PI, which includes collection, compilation, documentation and analysis of clinical research data in accordance with the protocol, ICH/GCP guidelines, Company SOPs. Duties include

•Coordinated and participated in phase II clinical trials.

•Maintained all IRB submissions and approved documents as necessary.

•Served as liaison at the Site, CRA and PI.

•Completed, reviewed and maintained source documents and CRFs clinical trials.

•Participated in protocol review or study procedure planning meeting.

•Taken Oracle training thereby optimizing accurate and complete data captured at each subject’s Visits.

•Design and created subject tracking charts to ensure timely data entry and subject visit scheduling.

•Obtained and documented proper informed consent prior to study-related procedures.

•Reviewed source documents and case report forms for completeness, data integrity and accuracy.

•Ensured patient data is collected and entered into various EDC systems in a timely matter.

•Reviewed drug instructions and PI compliance importance with subjects.

•Completed and maintained all study drug accountability records.

•Reviewed all study related documents for adverse events and serious adverse events.

•Coordinated with study monitors to address any questions or issues and resolve data queries requiring attention.

WORK EXPERIENCE:

Currently working as Ophthalmic Assistant:

Sept 2018-till date- Eye Care Consultant of NJ, New Jersey, USA as Ophthalmic Assistant.

Past Work Experience as Optometrist and Clinical Research Coordinator:

July 14-sept14 Voluntary worked as Ophthalmic technician with Dr Alisha Kim at Maryland Eye Center, Rockville, MD, USA.

June ‘11- June ‘12 Former Full time consultant Optometrist with Dr. Dilip S. Gaitonde, MD and Dr. Sharang Wartikar, MD at Bhaskar Eye Clinic, Mumbai, India

Feb 11-May 11 Former Full time consultant Optometrist at Just Diabetes, Mumbai, India

Sept ‘09 - Sept ’10 Former Full time consultant Optometrist with Dr. Alay Banker, MD, Banker Retina Clinic and Laser center, Ahmedabad, India,

Worked as a Clinical Research Coordinator in Phase 2 International Clinical Trials of “MONET” study by Pfizer at Banker Retina Clinic, Ahmedabad, India

May ‘08 - April ’09 Owned Optometrist Clinic as Gadda eye Care Centre, Digras, India.

Nov ’06 – April ’08 - Former Full time as consultant Optometrist with Dr. Vatsal Parikh, MD, Drushti Eye and Retina Centre, Mumbai, India.

Feb ‘07 - March ’08 - Former Part time consultant Optometrist with Dr. Vaishal Kenya, MD, Sarvodaya Trust Hospital, Mumbai, India.

April 07-sept ’07- Former Part time locum optometrist at Belle Vision Optics, Mumbai, India

Non Profitable Service as Optometrist

Jan ‘05-Jan’06 Participated in “Sight for Kid’s” eye camps, by Lions Club, Mumbai, India.

Jan ‘06-Jan ’07 Participated in “Refraction Eye camps” by Sindhi Society Trust, Mumbai, India

July ‘04-July ’06 - Participated in “cataract screening camps” by Lotus Trust Hospital, Mumbai, India.

Jan ‘08 & Jan ’09 - Participated in “Cataract Eye camp” by Bidada Sarvodya Trust, Bidada (Kutch) Gujarat, India

Personal details:

DOB : 06/07/1985

Nationality : Indian

Language : English, Hindi, Marathi, Gujarati & Kutchhi.



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