Yusra Maryam

Dedicated Clinical Research professional with over 5 years of experience managing complex clinical trials from initiation to close-out. Proven ability to lead local study teams, coordinate cross-functional contributors, and ensure regulatory compliance with Health Canada guidelines and GCP. Adept at tracking timelines, managing budgets, and mitigating risks to deliver studies on time and within budget.

Seeking to leverage expertise in operational delivery and stakeholder management to drive successful clinical study execution at GSK.

Clinical Research Coordinator at Sunnybrook Health Sciences Centre (2019-11 – 2024-04)

• Functioned as part of an interdisciplinary, patient-focused team of professionals to ensure smooth and efficient facilitation of clinical trial activities
• Managed day-to-day activities of a clinical trial including screening and recruiting eligible participants, obtaining informed consent, collecting and managing study data and ensuring compliance with protocols and regulatory guidelines
• Worked with several teams to ensure protocol training was up-to-date and the study team was in compliance with study protocols, local SOPs, and REB and Health Canada guidelines
• Ensured the validity and accuracy of clinical data collected with a focus on data integrity and patient safety as dictated by trial protocols and ICH-GCP guidelines
• Served as the primary point of contact for investigative sites, managed query resolution, participated in Investigators' Meetings, and completed project tasks in accordance with study timelines and budget
• Supported, managed, and coordinated submissions to Research Ethics Board
• Worked with clinical monitors to ensure site initiation, interim monitoring and close-out visits were completed in a timely manner
• Liaised with sponsors as required and prepared for monitoring visits, audits and inspections
• Worked closely with Principal Investigators and interdisciplinary teams to support the activation and coordination of multiple clinical trials and ensured accuracy and maintenance of all Trial Master Files

Clinical Research Associate at Royal Victoria Regional Health Center (2019-01 – 2019-05)

• Assisted with laboratory processing and shipping of specimens, and supported study start-up activities.
• Executed mock-audits of active clinical trials to ensure readiness for a Health Canada inspections
• Administered regulatory documentation for multiple clinical trials, including study amendments and associated training records.
• Completed ARIA training, mastering navigation of the software to retrieve necessary information.
• Developed Training Attestation forms for study team members, including the Principal Investigator, study staff, and pharmacy personnel.
• Leveraged Medidata RAVE for study data entry, query resolution, and contributions to quality improvement initiatives.

Teaching Assistant at University of Waterloo (2012-09 – 2017-05)

• Facilitated student learning and conducted laboratory demonstrations of fundamental lab techniques.
• Provided grading support, gained proficiency in wet lab techniques, and served as an assistant lab technician.

Research Assistant (Psychology Lab) at University of Waterloo (2016-05 – 2018-06)

• Designed experiments and prepared study materials utilizing PsychoPy and Qualtrics.
• Conducted literature searches and performed data abstraction to author research papers and develop posters.
• Mastered the use of SONA for study creation, participant recruitment, and scheduling.
• Gained expertise in SPSS for data collection, entry, and coding across various experiments.
• Developed online experiments for audio file recording using HTML.
• Assembled and submitted ethics approval applications and subsequent modifications as required.

Graduate Certificate in Clinical Research – Seneca College (2018 – 2019)

B.A. Honours in Psychology (Research Intensive) – University of Waterloo (2016 – 2018)

B.Sc. Honours in Biology – University of Waterloo (2010 – 2016)