Dr. Nitixa P. Patel

Trenton-NJ-*****

Cell no: +1-551-***-****

Email: adrobe@r.postjobfree.com

Summary

Highly motivated, goal-oriented Physician and Master in Anatomy with expert in clinical trial management and clinical research work (1 year) from India with teaching experience of 21 years in Anatomy in Medical College, as well as experience of treating patients in hospitals, ICU and in private clinic, seeking a career position in the Healthcare field or Pharmaceutical industry and Clinical research site to enhance professional skill set and knowledge.

Skills

Oral and written communication

Time management

MS Office expert

Fluent in Hindi,Gujarati & English

Education:

Certification: Clinical trial Management

Sollers college- New Jersey, Edison, USA, in January 2022 (6 months internship)

Certification: Advanced Post graduate Diploma in Clinical Research & Pharmacovigilance

James Lind Institute, Bengaluru, India in March 2022

Master’s degree in Anatomy (M.D. ANATOMY)

Veer Narmad South Gujarat University, Gujarat, India in July 2016.

Bachelor’s degree in medicine and surgery (M.B.B.S.)

First professional degree in medicine (Doctor of Medicine): GPA- 3.00 World education services evaluation scope: U.S Equivalency.

Sardar Patel University, Gujarat, India in August 1994.

Work History:

Clinical Trial Management & Pharmacovigilance

Skills:

Strong understanding of ICH-GCP-E6 guidelines, FDA regulations and medical terminologies

Trial master file and reconciling eTMF; proficiency in CTMS

AE and SAE reporting and administrating Informed Consent

Able to verify data accurately in the EDC system.

Case Report Forms using Oracle Clinical Application

Expertise in data analysis & verification, reports generation and documentation

Familiar with Oracle Clinical and SAS

Microsoft Office (Word, Excel, Power point)

Work experience: (July 2021-march 2022)

Organization: Sollers College, Edison, NJ.

Gained strong understanding of human subject protection for clinical trials, ethical and regulatory compliance of US FDA/ICH/GCP regulatory requirements, IRB functions, HIPAA and more.

Manages and executes IRB submissions for initial approval, containing reviews, amendments, protocol deviations and adverse events, while ensuring timelines and accuracy of all submissions.

Reviewed and reconciled all essential documents of the Trial Master File(TMF) in compliance with SOPS, GCP, and ICH Guidelines

Conducts study tracking and updates (e.g., CTMS, start-up, milestone, close-out); generates, reviews, and distributes management reports from internal tracking systems at requested intervals

Reviewed study case report forms (CRFs) completed by the investigative sites; verified entries by validating accurate source documentation to support CRF entries

Gained knowledge for monitoring study sites and clinical activities and making reports

Maintain specific records of research activity to include regulatory forms, drug dispensation records, case reports and consent forms.

Assists with preparation of investigational site reference materials (i.e.,screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)

Assists with preparation of investigational site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)

Tutor/Instructor in anatomy (2000-2022)

Work experience: 21yrs &3 months

Organization: Surat Municipal Institute of Medical education & Research, India.

Teaching Undergraduate medical students (1st M.B.B.S).

Delivering Theory lectures related to general anatomy, gross anatomy, embryology, histology, and genetics with the use of various audiovisual aids.

Practical teaching through using of various methods of learning like tutorial, seminars, demonstrations, group discussion.

Teaching Human cadaver dissection techniques.

Demonstration of human bones, soft parts, embryology models, charts, museum specimen making.

Reading of skiagram/radiograph including MRI and CT scan.

Histology slide preparation and its study.

Providing project to students and engaging them for study motivation and research work.

Preparation of human donated dead bodies for future dissection and teaching purpose through various arterial approaches like carotid artery, femoral artery, subclavian artery.

Practical help in study of different types of microscopes, tissue processing, section cutting, staining and preparation of slides.

Demonstration of embryology models and museum specimen of congenital anomaly.

Helps in preparation Barr Bodies, procedures of Karyotyping and reading of pedigree chart.

Private General medical practitioner (1998-2000)

Work experience: 2yrs

Conducting own private clinic: to performed patient examination and diagnostics as well as designed healthcare treatment plans and therapies.

Research work/presentation/publication:

Poster presentation:

“Abnormal Course of Left Testicular Artery in Relation to An Abnormal left Renal Vein; A case Report.”

Research paper presentation:

“A Study of Incidence of Bridges of Human Atlas Vertebra In South Gujarat Population.”

Research paper Publication:

a)“Incidence of Ponticles in Human Atlas Vertebrae -A Study from South Gujarat Population.” Published in Indian Journal of Clinical Anatomy and Physiology.Vol-2

b)“A Morphometric study of Adult Human Atlas vertebrae in South Gujarat Population, India” Published in International Journal of Research in Medical Science.vol-4

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