Senior Clinical Research Associate with MBBS background

Brampton, Monaliben ON • +* ***-***-Patel **** • monap7950@(Msc, gmail.CCRP) com

Clinical Research Coordinator

Experienced SOCRA Certified Clinical Research Coordinator and Medical Officer with 3+ years of experience in conducting patient care visits and ensuring compliance with regulations. Proven track record of successfully administering questionnaires and obtaining consent for studies. Collaborated with clinical research associates to facilitate monitoring and database clean-up processes. WORK EXPERIENCE

Clinical Research Coordinator: Newmarket, Ontario, Canada 05/2021-Present

● Inform patients about study objective, administering questionnaires, obtaining required consent - Adhere to research regulatory and ethical standard - Maintain protocol requirements for patient visits, patient visit schedules, blood draw, test procedures, and drug accountability requirements - Complete all study documentation forms like case report form and other specific research documents - Conduct patient care visits and assure that all the procedure are performed in compliance with the standard of the clinic and ICH-GCP guidelines - Interact with investigators to assure that the patient receives appropriate medical evaluation and care, when needed - Interact with clinical research associate to facilitate monitoring and database clean-up process - Attend meetings and conduct clinical research in compliance with all the applicable regulations

● Recruited 35+ subjects for clinical trials, meeting enrollment goals and expediting study completion for improved patient care.

Clinical Research Associate: Hyderabad, India, 09/2020 - 05/2021

● Carry out selection, initiation, monitoring and close-out visits at the participating clinical trial centres, also for logistics and coordination of the study;

● Monitor the study to check whether it has been carried out in accordance with applicable laws and regulations;

● Manage study supplies, medication supplies and medication accountability;

● collect, verify and finalise collected data to create reports and present results of findings to other medical staff;

● Participate in vendor management and oversight

● Contribute to the development of study training and ancillary project management materials including databases and trackers

● Review and maintain study level clinical plans (including, but not limited to, site monitoring plan, deviation plan, data management plan)

● Manage the Trial Master File (TMF) and perform ongoing quality reviews

● Additional responsibilities as assigned.

EDUCATION

M Sc In Clinical Research Regulatory Affairs

Northeastern University • Toronto, Ontario, Canada • 09/2021 - 06/2023 M.B.B.S. Bachelor Of Medicine And Bachelor Of Surgery Medicine Gmers Medical College • Gandhinagar, Gujarat, India • 06/2013 - 03/2019 CERTIFICATIONS

Certified Clinical Research Professional

SOCRA • 01/2024 - Present

Tcps 2 : Core Panel On Research Ethics

04/2022 - 04/2025

Basic Life Support certificate from GMERS Medical College Gandhinagar ICH Harmonised Guideline Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)

Health Canada Food and Drug Regulations Part C, Division 5: Drug for Clinical Trial Involving Human Subjects

PROJECTS

Clinical study

Currently working on 9 clinical study independently Two Hidredenitis suppurativa

● Four study of Eczema

● Five study of Psoriasis

SKILLS

Attention to Detail, Problem Solving, Research Ethics, Resiliency, Facilitate, Research, Conduct Clinical Research, Drug Accountability, Clinical Practice, Case Report Form, Microsoft Office, Research Skills, Healthcare, Phlebotomy

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