Brendon N.

Clinical Research Supervisor specializing in dermatology clinical trial operations, site leadership, regulatory compliance, and audit readiness. Experienced in overseeing multi-study clinical research workflows across psoriasis, atopic dermatitis, hidradenitis suppurativa, prurigo nodularis, and other inflammatory skin disease trials. Lead day-to-day site operations including feasibility, study start-up, IRB/REB submissions, delegation and training oversight, source documentation, ISF maintenance, monitoring visit preparation, protocol deviation management, CAPA development, query resolution, vendor coordination, and sponsor/CRO communication. Skilled in improving clinical trial execution through structured tracking systems, compliance dashboards, workflow automation, risk-based oversight, and process improvement initiatives. Strong background in EDC, IRT/IWRS, eCOA, safety reporting, lab/sample shipment workflows, temperature log reconciliation, and inspection-ready documentation. Known for combining clinical knowledge, operational discipline, and regulatory judgment to reduce site risk, improve documentation quality, support investigator oversight, and keep high-volume dermatology trials moving efficiently.

Mid-level Senior Clinical Research Coordinator in dermatology and autoimmune disorders, ensuring compliance with all regulatory authorities, GCP, GLP and GDP. - Clinical Trials Management: Expert in clinical trials, protocol review, and informed consent administration, serving as lead and backup coordinator. - Quality Assurance: Rigorous adherence to protocol requirements, precise medication accountability, and accurate documentation, including successful FDA, Health Canada, and Sponsor audits. - Data Management: Proficient in clinical data management, data entry, and resolving queries to ensure data accuracy. - Regulatory Compliance: Maintaining trial regulatory documents, and facilitating sample shipping while adhering to strict protocols. - Photographic Training: Trained in capturing high-quality photographs to document the extent of disease progression, ensuring comprehensive and visual data representation. - Protocol Procedures: Proficient in procedures like spirometry, ECG, phlebotomy, SC injections, and sample processing, contributing to smooth trials. - Training and Mentoring: Key role in mentoring and training new recruits, sharing expertise and knowledge for their success in the field.

- Managed clinical trials, reviewed protocols and administered informed consent forms to study subjects - IRB/REB submission - Served as lead and backup coordinator for clinical trials in dermatology and autoimmune disorders. - Ensured adherence to protocol requirements and managed medication accountability and distribution - Documented adverse events, medical history, and clinical notes in compliance with protocol requirements - Conducted data entry using various platforms including RAVE, ERT, RedCap, Medrio, Inform and Veeva Vault - Resolved data queries in a timely manner to maintain accurate records - Communicated with central ethics board representatives and maintained trial regulatory documents - Conducted protocol procedures such as spirometry, ECG, phlebotomy, SC injections and sample processing - Facilitated shipping of biological samples and ensured compliance with dangerous shipping protocols - Assisted with monitoring visits, site initiation visits, and completion of site feasibility questionnaires - Demonstrated proficiency in medical terminology, effective communication, and problem-solving skills - Maintained exceptional attention to detail and accuracy in all tasks and documentation

- Managed clinical trials, reviewed protocols and administered informed consent forms to study subjects - IRB/REB submission - Served as lead and backup coordinator for clinical trials in dermatology and autoimmune disorders. - Ensured adherence to protocol requirements and managed medication accountability and distribution - Documented adverse events, medical history, and clinical notes in compliance with protocol requirements - Conducted data entry using various platforms including RAVE, ERT, RedCap, and Medrio - Resolved data queries in a timely manner to maintain accurate records - Communicated with central ethics board representatives and maintained trial regulatory documents - Conducted protocol procedures such as spirometry, ECG, phlebotomy, SC injections and sample processing - Facilitated shipping of biological samples and ensured compliance with dangerous shipping protocols - Assisted with monitoring visits, site initiation visits, and completion of site feasibility questionnaires - Demonstrated proficiency in medical terminology, effective communication, and problem-solving skills - Maintained exceptional attention to detail and accuracy in all tasks and documentation

- Engaged directly with study participants as a patient-facing Sub-Investigator in an orthopedic surgery clinical study - Assisted in the recruitment and screening of eligible patients, ensuring informed consent and patient understanding - Conducted thorough assessments and evaluations of patients, documenting their medical history and relevant data - Provided compassionate care and support to pregnant patients suffering from ankylosing spondylitis, back pain, or spinal injury - Administered study procedures to patients, ensuring their comfort and compliance with protocol requirements - Acted as a liaison between patients and the study team, addressing concerns and providing education about the study - Documented and maintained accurate patient records and study-related documentation - Oversaw delegated responsibilities of clinical research coordinators - Collaborated with the research team to analyze patient data and contribute to the overall understanding of the clinical association - Prioritized patient safety and well-being, adhering to ethical standards and regulatory guidelines - Played a vital role in advancing orthopedic research by actively engaging and supporting patients in their participation

- Accomplished medical intern recognized as "Intern of the Month" during Hematology department rotation - Proficient in conducting comprehensive patient assessments and developing evidence-based treatment plans - Skilled in assisting attendings with various procedures and maintaining patient records with confidentiality - Experienced in updating and managing electronic medical records (EMR) - Effective communicator, engaging with internal and external stakeholders regarding patient procedures and follow-up appointments - Demonstrates versatility, fast learning, and a compassionate patient-centred approach - Committed to upholding ethical standards and lifelong learning - Dedicated to contributing to healthcare excellence and making a positive impact in patient care

- Proficiently followed SOPs and work instructions to ensure a reduction in sample analysis errors - Accurately, aseptically and efficiently prepared and analyzed biological and chemical samples - Worked independently and within multi-disciplinary teams to achieve analysis of samples completion ahead of schedule - Assisted in the development and drafting of key performance indicators (KPI) and monthly progress reports - Maintained a high level of professionalism and confidentiality when working in the biohazard level 2 microbiology laboratory - Assisted in the development and maintenance of SOP and training of new co-op students - Aided in the maintenance of QC logs and tracking of laboratory supplies

- Assisted school administrators in developing an enhanced English curriculum with additional extracurricular activities to improve communication skills - Successfully taught and mentored over 10 students each semester - Documented and tracked student performance to showcase their progress and growth - Coordinated office activities and operations to ensure efficiency and compliance with school policies - Supervised and delegated responsibilities among staff members to optimize performance and productivity - Provided administrative and technical support to the administrative team - Demonstrated strong organizational and multitasking skills in managing administrative tasks - Contributed to creating a conducive learning environment for students through effective administrative capabilities

- Research Assistant involved in the analysis of data for the study on the association of ATG4C as a susceptible gene in Kashin-Beck disease - Utilized PASW Statistics software for data analysis and interpretation - Demonstrated efficiency in working with Microsoft Office suite, including Excel, Word, and PowerPoint - Collaborated with the research team to organize and clean datasets for analysis - Conducted statistical analysis and applied appropriate statistical methods to interpret research findings - Assisted in the preparation of research reports, presentations, and scientific manuscripts - Ensured data accuracy and integrity by performing thorough quality checks and validation procedures - Contributed to the development and implementation of data management protocols and standard operating procedures - Maintained a systematic and organized approach to data organization and documentation - Worked closely with the Principal Investigator and research team to meet project timelines and objectives

Hematology, Microbiology, Molecular biology, Immunology, Epidemiology, Pathology, Pathophysiology, Clinical Research, Clinical Medicine, and Internal Medicine