Clinical Research Coordinator III

Nilam Babulal Patel

E mail: adilgo@r.postjobfree.com

LinkedIn: linkedin.com/in/nilam-patel-5713601aa

Professional Summary

Dependable Clinical Research Coordinator with 2.5 years of experience with all aspects of clinical trials in adherence to the Protocol, ICH/GCP E6(R2), the United States Code of Federal Regulations, ICH Clinical Safety Data Management: Definitions and standards for Expedited Reporting (E2A), Human Research Protection Program (HRPP), the ethical principles of the Nuremberg Code, the Belmont Report, the Declaration of Helsinki, and other applicable federal, state, and local laws and policies.

Clinical Research Experience

Clinical Research Coordinator III October 2015 to April 2018

Apollo Research and Innovations,

Apollo Hospitals International Limited,

Gandhinagar, Gujarat, India

Worked as a primary Clinical Research Coordinator across multiple therapeutic indications named Pulmonary Arterial Hypertension Phase III, Breast Cancer Phase IV, Myocardial infarction Phase III, H1N1 vaccine trials phase II, Rabies vaccine trial phase II & III, Vit B12 Nasal Spray Phase IV, BP monitoring medical device PMS study, Chronic Obstructive Pulmonary Disease (COPD) PMS study and Heavy Metal Poisoning Phase 1 trial.

Spearheaded study-start up activities including but not limited to feasibility completion and follow up, HRPP activities, Site Initiation Visits and Pre-Site Initiation Visits, and maintaining feasibility register.

Performed screening and enrollment of potential study participants eligibility, patient randomization through IVRS, and IWRS, drug accountability, blood processing for central lab investigations i.e. Covance, Eurofins.

Prepared and Submitted monthly progress reports, payment invoices to clinical trial manager and tracked patient enrollment, and corresponding payments from sponsor.

Prepared and coordinated study documents, CRF binders, IRB submissions, regulatory binders, CIOMs and other study supplies.

Ensured timely and accurate source documentation, CRF data entry in RDC and RAVE iMedidata software, and resolution of queries.

Worked closely with site manager to develop follow up corrective plans for source documents, CRFs, Regulatory files and IRB documents for regulatory and IRB audits.

Skills

Informed Consent Procedures, IRB, Regulatory documents, Study Drug Accountability, Study start up activities, Source documentation, Adverse Events and Adverse Drug Reactions reporting, Clinical Trials,, Central lab investigations, Patient safety, Study Protocol, Electronic Data Capturing, FDA, Investigator Meetings

Education

Master of Healthcare Administration, 2020

University of the Potomac, Virginia

GPA: 4, Scholarship awarded

Post Graduate Advanced Certificate course in Clinical Research, 2015

Apollo Hospitals Educations and Research Foundation, Ahmedabad

& Anna University, Chennai, India

1st Rank Holder

Master of Science in Biotechnology, 2010

Ganpat University, Mehsana, India

First class

ICH GCP Training

ICH Good Clinical Practice E6 (R2) online training- June 2020

NIDA Clinical Trials Network Good Clinical Practice (GCP) training- June 2020

Workshops and Research Training

Attended One Day Sensitization Workshop on Research Methods at National Institute of Epidemiology, Chennai March 25, 2015

Standardization of Study of DNA Damage in Male Reproductive cells

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