Erum Baig

• Lead the coordination and monitoring of multi-phase oncology clinical trials focused on diet, nutrition, and physical activity interventions for patients undergoing chemotherapy and in remission, ensuring strict adherence to ICH-GCP, FDA, and institutional regulatory guidelines. • Act as the primary liaison between key recruitment sites to manage and review research agreements with external sponsors and collaborators for multi-site clinical studies—including Sunnybrook Hospital, Princess Margaret Cancer Centre, and Mount Sinai Hospital • Work closely with institutional legal and contracts offices to facilitate timely negotiation and execution of agreements • Conducted medical literature searches using scientific databases and critically evaluated published literature to support clinical research activities and study documentation • Coordinate subject recruitment and foster strong relationships with physicians, nurse navigators, and multidisciplinary care teams. • Conduct site initiation, interim monitoring, and close-out visits across multiple investigator sites; assess site performance, resolve protocol deviations, and ensure the integrity and quality of collected data. • Monitor and verify CRFs and source documents for accuracy and completeness, identifying data discrepancies and coordinating timely resolution with site staff and data management teams. • Prepare and manage study budget projections, oversee spending, and ensure appropriate financial controls • Track billable study activities and additional project-related expenses; prepare and submit invoices for cost recovery • Maintain oversight of participant visit schedules to ensure protocol compliance and accurate cost attribution • Perform phlebotomy procedures including blood draws, processing, labeling, and preparing biospecimen samples for laboratory analysis; coordinate transportation of biological samples in accordance with Transportation of Dangerous Goods (TDG/IATA) regulations.

Transcribed patient visits in real time, capturing medical history, physical exams, assessments, and treatment plans Ensured accuracy, clarity, and completeness of SOAP notes and documentation for physician review Collaborated with healthcare providers to improve efficiency and accuracy of clinical records Maintained confidentiality and compliance with HIPAA and medical documentation standards

Reviewed and revised study protocols, consent forms, and SOPs for REB and regulatory submissions Ensured compliance with ICH-GCP, TCPS2, NIH, and Health Canada standards across multiple trials Supported Principal Investigator during sponsor and stakeholder meetings as subject matter expert Managed adverse event documentation, follow-up, and reconciliation to ensure timely reporting Participated in internal audits and QA processes to maintain adherence to clinical and regulatory standards

Managed clinical trials from initiation through close-out, overseeing budgets, resources, and timelines Coordinated participant recruitment, data collection, and laboratory procedures under GCP standards Implemented protocol amendments and maintained compliance during the COVID-19 pandemic Facilitated sponsor communication, audit preparation, and site visit coordination Collaborated with cross-functional teams to ensure study objectives and milestones were met

Managed daily operations and physician workflows for comprehensive health assessments Provided professional client service, resolving issues efficiently to enhance patient satisfaction Trained physicians and staff on new EMR systems to optimize clinic productivity Maintained scheduling efficiency and supported cross-departmental coordination

Performed physical exams, ECGs, and vital sign assessments under physician supervision Collected and documented patient medical histories and diagnostic results Assisted in developing treatment plans and implementing clinical protocols Revised SOPs and policies to improve accuracy and consistency in diagnostic testing

Assisted in laboratory-based research studying stem cell responses to inflammation Processed biological samples and performed gel electrophoresis, PCR, and western blotting Maintained accurate data records and ensured compliance with lab safety protocols Supported data analysis and contributed to ongoing research documentation

Clinical Research, Drug Safety & Pharmacovigilance Drug Lifecycle Safety Management & Compliance GMP, GCP & GVP Inspections/Audits Intro to Pharmacovigilance, Statistical Analysis & Clinical Research Clinical Trials: Protocol, ICF, Monitoring & Project Management Regulatory Affairs: Biotech, Biologics, Generics, Devices & NHPs Canadian Pharmaceutical Industry Overview Technical Writing & Scientific Communication Clinical Data Acquisition & Management Legislation, Ethics & Safety Assessments Medical Devices, Medical Cannabis & Pharmaceutical Biotechnology