Clinical Research Coordinator

AMREEN SULTANA SHAIK

Boston, MA ***** ***************@*****.***

https://www.linkedin.com/in/amreen-sultana-shaik-a30884123

Education:

Master of Science in Clinical Research May 2023

Massachusetts College of Pharmacy and Health Science, 3.86 / 4.00 Boston, MA

Master of Pharmacy in Pharmacology Aug 2019

Chalapathi Institute of Pharmaceutical Sciences, 3.89 / 4.00 Guntur, India

Bachelor of Pharmacy May 2017

Chalapathi Institute of Pharmaceutical Sciences, 3.79 / 4.00 Guntur, India

Skills:

Domain skills:

Drug discovery and development process, including different phases of clinical trials, which include study design, randomization procedures, and Case Report Forms

Protocol writing and protocol handling, Patient/subject recruitment, Informed Consent Process, Site Monitoring for compliance with protocol and other regulatory guidelines such as IRB

Declaration of Helsinki and ICH-GCP, Code of Federal Regulations (CFR)

Trial Master File (TMF) and Clinical Trial Documentation and review by using Veeva vault

Essential document lists and Milestone review for e-TMF

Technical skills: Microsoft word, Power point, Outlook, Teams, SharePoint, Zoom

Languages: Hindi (Fluent), Urdu (Fluent), Telugu (Conversational)

Work Experience:

TMF Document Specialist I Mar 2021 – July 2021

Syneos Health Hyderabad, India

Performed gap and non-gap analysis related to the set-up, maintenance, and close out of the Electronic Trial Master File (e-TMF) for nine studies sponsored by Ixaka Limited, Allergan Inc, Omeros Corporation, Eli Lilly and Company.

Processed study documentation for compliance with FDA, site visits, agreements, and certifications/training of the study staff in accordance with study-specific TMF Plans and other applicable guidelines.

Performed quality review of documents of the studies submitted for entry into the e-TMF and liaised with respective project teams to resolve the issues identified.

Research Experience:

Clinical Research Intern Apr 2019 – Mar 2020

Jeevan Scientific Technology Limited Hyderabad, India

Involved in all the tasks from screening to the follow-up of the clinical subjects for two studies.

Preliminary screening for enrolling the study subjects based on inclusion and exclusion criteria of the study.

Participated in clinical protocol training for conducting trials in accordance with the protocol.

Obtained informed consent from the subjects or their representatives in case of vulnerable populations for enrolling them into the study.

Check-in and check-out of the enrolled subjects at the study site.

Dosed the subjects based on the treatments assigned during randomization.

Assisted phlebotomist during sample collection (blood) from the subjects.

Followed-up with the subjects to determine adverse events (AEs/SAEs) or to determine study-related outcomes (based on the study protocol).

Assisted in document control by performing quality control and quality assurance related tasks of the study-related documents such as subject registration forms, screening forms, screening reports, informed consent forms, and study reports by following the HIPAA regulations.

Additional Skills:

Worked as an Event Coordinator at Chalapathi Institute of Pharmaceutical sciences during the academic years 2015-2016, 2016-2017, 2017-2018, 2018-2019.

Working (part-time) as a Guest Services Coordinator at Department of Fitness and Wellness of Wentworth Institute of Technology.

Certifications:

1)Basic Human Subject Research 2022

CITI Program Valid through Feb 2025

Basic course for biomedical research involving human subjects including chart reviews.

2)Advanced Post Graduate Program in Clinical Research & Management 2020

CliniIndia Hyderabad, India

Clinical Trial Management: Drug Discovery and Development Process, History of Clinical Research, Design and phases of Clinical Trial, ICH-GCP guidelines, Informed consent process, Responsibilities of stakeholders of Clinical Trial, Protocol, and Case Report Form (CRF) designing.

Clinical Data Management: Clinical Data Management System (CDMS) and CDM process flow, Data management Plan, Discrepancy and Query Management, Medical coding by MedDRA and WHODD, CRF designing (Paper base and e-CRF), and CRF Annotation Using SDTM model.

Pharmacovigilance: Adverse drug reaction and Adverse event, PVPI and Pharmacovigilance role, Risk Management, Adverse event reporting (Medwatch form), Causality assessment.

Medical Writing: Safety Writing, Regulatory Writing, Clinical Writing, Writing for Medical Communication, and Regulatory Submissions.

Awards:

1st prize in Science Expo held at Chalapathi Institute of Pharmaceutical Sciences for demonstrating animal handling, dosing, and blood collection techniques during the academic years 2016-2017 and 2018-2019.

3rd prize in e-poster competition held at Chalapathi Institute of Pharmaceutical Sciences in Aug 2018.

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