My name is Syed Ramsh Ali Zaidi, I am a foreign medical graduate, having earned my MBBS in Pakistan, where I worked as a Physician. I'm a permanent resident in the US (Green Card holder). Having transitioned into Clinical Research, I am working at IQVIA as a Clinical Research Associate in the Neurology and Oncology therapeutic areas.

Working in this industry has afforded me the opportunity to work closely in clinical trials maintaining patient safety. In my career so far, I have been fortunate to have had 3 years of experience in the management of multiple clinical trial protocols in various phases monitoring, report and review of Adverse Events, Serious Adverse Events in patients participating in clinical trials.

As a doctor, this Clinical Safety Analyst role really excites me and is one that I see as a natural progression in my career, a position in which my medical knowledge and experience with patient safety would allow me to adapt quickly allowing me to contribute to the team sooner rather than later and make a real impact in the position. I have attached my resume to this application. Please, do not hesitate to reach out to me for any questions or details about my experience. I look forward to hearing from you soon. Have a wonderful day!

I earned my international medical degree, MBBS from Karachi, Pakistan.

Jinnah Sindh Medical University

• Reviewing Adverse Event (AE) and Serious Adverse Event (SAE) data in patient Case Report Forms and EMR to confirm adequate reporting and documentation of such events and identify any risks to patient safety in clinical trials.
• Reviewing and monitoring subject safety profiles.
• Performing site monitoring visits (selection, initiation, monitoring and close-out visits) according to the scope of work and regulatory ICH/GCP requirements.
• Administering protocol and related study training to assigned sites and establishing regular communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Managing the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Ensuring copies/originals site documents are available for filing in the Trial Master File &#40;TMF&#41; verify that the Investigator's Site File &#40;ISF&#41; is maintained in accordance with ICH/GCP and local regulatory requirements.

Clinical Research Associate

• Actively involved in reviewing safety reports (SUSARs) for potential Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO) to determine if it necessitates a change to the Informed Consent Form (ICF), protocol, and/or investigator brochure (IB).
• Managing all aspects of conducting clinical including: screening, enrollment, subject follow-up, completion and analyzing of the case report form, and adverse event reports.
• Recruiting and interviewing potential study patients with guidance from PI and other clinical research staff. Collecting, processing, shipping and storing specimens to appropriate laboratories. Performing assessments at visits.

Clinical Research Coordinator

• Create and maintain patient profiles, including adding personal information, medical records, AEs and SAEs in CTMS.
• Study documentation and data entry, schedule/reschedule patients into a Clinical Trial Management System &#40;CTMS&#41;.
• Assist research coordinators with conduct of scheduled and unscheduled patient visits and routine tasks, prepping source documentation and visit supplies, discussing and processing medical release forms, and data entry into eCRF

Clinical Research Assistant

• Obtained medical history and performed physical examinations in an underserved outpatient setting and escalated any clinically significant findings to the attending physician.

Clinical Extern

• Obtained medical history and performed physical examinations in an inpatient setting and escalated any clinically significant findings to the attending physician.

Clinical Observer

• Performed tasks expected of a licensed physician for patient in the inpatient and outpatient setting.
• Coordinated care with consultant physicians, nurses, and various other departments
• Educated and instructed patients regarding their illness and medications, including adverse drug reactions
• Assisted senior physicians as necessary in their responsibilities including surgical interventions (e.g., blood draw, NG tube insertion, lumbar puncture, etc.)
• Gained competency in the following therapeutic areas: General Medicine, Pulmonology, Gastroenterology, Endocrinology.

Syed Zaidi

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