Clinical Research Trial

Wael Mohammed ***************@*****.***

Mississauga, Onatrio, 647-***-****

Consultant Physician & Certified Clinical Research Professional

Summary

Canadian skilled and insightful certified clinical research professional with expertise in multiple facets of clinical research and medical practice. Well-versed in research methodologies and procedures involving human subjects from informed consent and questionnaire development, adherence to GCP and detailed protocols, conducting multiple clinical research trials including phase two and three trials. Strong statistical insight, examining complex data from multiple sources to identify patterns and potential contributing factors.

Areas of Expertise

•Clinical Trial Administration • Statistical Analysis • Intercultural Communication

•Participant Interactions • Regulatory Compliance • Cross-Functional Teams

•Laboratory Equipment • Electronic Records Systems • Training & Development

Professional Experience

Clinical Research Coordinator

Bone Research & Education Center 02/2024-till present

Senior Clinical Research Coordinator 05/2023-01/2024 Uptown Eye Specialists

· Oversees the daily clinical trial tasks, is detailed orientated and organized and ensures effective communication to all research stakeholders.

· Coordinates and supports operational aspects for implementation of ophthalmology clinical trial activities from study start-up through close-out, ensuring quality and safety standards, regulations, protocol adherence and timelines are met.

· Prepares and negotiates clinical trial budgets with sponsors. Implements payment tracker to track study payments.

· Ensures adverse events are documented and reported in a timely manner to sponsor.

· Responsible to ensure good documentation practices and ensures accurate clinical trial data is entered into EDC. Responds to data queries in a timely manner.

· Ensures Investigator's Products (IPs) are stored according to the sponsor requirements and destroyed IPs according to the clinic SOPs.

· Reviews patients’ chart to identify potential subjects for clinical trials. Educates the subjects about clinical trial studies and obtains informed consent from them to determine eligibility.

· Completes all the regulatory essential documents for the study are filled appropriately.

· Ensures that the sponsor is aware of the current status of the studies as well as documents and addresses any protocol deviations and CAPAs as required.

· Prepared site-specific ICF for sponsor review and negotiated with sponsor to ensure REB requirements are met.

· Acts as a point of contact when study participant has questions and concerns are escalated, related to the clinical intervention being delivered in the study.

· Responsible for oversight of study medical records, Providing timely study, updates/reports under supervision from the Principal Investigator.

· Document all records of research activities and present to sponsors as per protocols.

· Organize daily/weekly/monthly team meetings to ensure proper communication with all stakeholders.

· Responsible for collaborating with the Investigator, Corporate Research Coordinator and other relevant partners involved in the project both internally and externally during the conduct of the research and knowledge translation.

· Preparing and maintaining any study documents and materials as required.

· Proactively identifies barriers/threats/risks for project completion and work with team members.

· Coordinating study visits and collection of study data and materials.

· Organizing and coordinating the involvement of other hospital departments/divisions related to new and/or ongoing studies.

· Entering data, checking data for accuracy and completeness, including data re-entry; data cleaning.

· Use the log detailing activity to allocate the worked hours for each study project for financial and administration purposes

Clinical Research Coordinator

Gordon L. Sussman Research Inc. 07/2022- 04/2023

Performing different phases of clinical trials for allergy studies, including various required study procedures, as well as ECG, spirometry, and SPT. Observation of recruited participants, and implementing ICH-GCP guidelines.

Clinical Research Coordinator 11/2020- 07/2022

Cliantha Research, Mississauga, ON

Conduct phase two and three trials, obtain informed consent and establish patient eligibility by examining medical history and vital signs. Follow up with all patients to detect adverse drug reactions.

Informed all study participants of study processes and objectives to achieve informed consent for participation

Clinical Research Assistant

St. Michael Hospital 08/2017 – 01/2020

Facilitate effective execution of multiple clinical trials, ensuring alignment with all relevant regulations and ethical standards. Demonstrated attention to detail in collecting and coding data, and strong analytical abilities when examining results obtained.

Contributed to Gemini team on multiple aspects of numerous clinical research studies, interacting closely with trial patients to provide information and support during study including selection, initiation, monitoring, and closure visits. Reviewed and validated thousands of clinical charts. Generated required paperwork including IRB forms, trained new researchers in all policies and procedures. Participated in regular meetings to assess trial progress and ensure continuing alignment with all ethical guidelines.

●Gathered and recorded data accurately including metrics, medical history, and individual adverse effects, aligning with both established clinical practice and international guidelines, entered in electronic report system.

●Contributed to QI of sedation reduction study: conducted survey to evaluate quality of patients’ sleep during period of admission via questionnaire, reviewed charts of sedative prescription retrospective data to identify naïve and non-naïve patients to determine inappropriate sedative prescriptions.

●Performed chart abstraction on over 8,000 patients across multiple study projects.

●Validated electronic clinical data for large clinical research database including chart reviews and onsite data validation for Redcap software system to support analytical approaches.

●Expanded participants’ awareness of study goals and risks by producing educational materials.

Ministry of Health, Kuwait 09/2003 – 06/2016 Internal medicine Specialist

Delivered full range of internal medicine services including medical exams, recording medical history, collecting blood samples, ordering laboratory tests, diagnosing illnesses, and providing appropriate treatment including education and counseling when appropriate. Maintained accurate and complete medical records for each patient covering full age spectrum.

●Led both qualitative and quantitative clinical pharmaceutical trials, ensuring compliance with local regulatory requirements and ICH guidelines.

●Participated in clinical studies of cervical cancer by obtaining PAP smears, evaluating results, and formulating statistics for high-risk pregnancies, outlined complications and relevant statistics.

●Safeguarded quality of information and results by preparing on-site and remote source document verification, data review, study product reconciliation, and regulatory and SOP binder reviews.

Additional Experience

Resident Doctor, Alexandria University Hospital, Alexandria, Egypt, 02/2004 – 02/2006

House Officer, Alexandria University Hospital, Alexandria, Egypt, 02/2003 – 02/2004

Education

Post-Graduate Diploma in Clinical Research Oxford

College, Toronto, Ontario, 2017 Post-Graduate

Diploma in internal medicine Alexandria University, Alexandria, Egypt Bachelor’s Degree in Medicine and Surgery

Alexandria University, Alexandria, Egypt

MCCQE1 JUN 2020

NACOSCE OCT 2021

OET MAR 2021

Professional Training

ICH- GCP Training Certificate, 2019

TCPS2: Core Certificate, Panel on Research Ethics

Phlebotomy certificate, GIMT College, Mississauga, Ontario, 2017

First Aid CCRR/ AED, Lancaster Medical Group, Mississauga, Ontario, 2017

Certified Clinical Research Professional (SOCRA), 2022

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