The Clinical Trials Specialist (CTS) participates in the development, coordination, and project management of clinical trials from protocol development/review, approval through to activation, follow-up and trial closure. The CTS is responsible for a wide variety of projects involving phase I, II, and III trials for various investigator-initiated sponsors, pharmaceutical, and biotechnology companies. Principals responsible include:- Project Management- Coordinating single and/or multi-centre studies- Protocol development, writing, and amendments- Regulatory compliance- Site Management- Communication with various stakeholder including sites, staff, and sponsor at all levels- Vendor Management - Utilize quality assurance procedures to ensure that high quality data is obtained- Ensuring studies are conducted in accordance with ICG-GCP, Health Canada, FDA and US Federal Code, as well as other regulatory agencies

Initiate 10+ studies, resulting in a 25% increase in the site’s revenue, by collaborating with sponsors, investigators and clinical research associates during feasibility questionnaires and study start-up activitiesDesign and execute strategies to boost patient enrolment by over 50% by leveraging targeted advertising, community outreach programs and collaborating with referring physiciansDevelop and standardize internal tools, templates and quality control measures, thus doubling the site’s patient accommodation capacity and enhancing operational efficiencyMentor, train and support a team of over 10 individuals, fostering their professional growth and success in clinical researchCultivate a supportive and positive work culture by organizing staff dinners and encouraging an environment of open communication, resulting in high levels of staff motivation and retention

Led 10+ clinical trials from site initiation visits through closeout, ensuring adherence to ICH/GCP and regulatory guidelinesConducted over 100 in-person patient visits by delivering patient questionnaires, recording medical information and administering study medicationClosely monitored patient health by performing medical procedures such as blood draws, ECG recordings and vital sign collection, escalating concerning findings to the principal investigator for reviewPrescreened and recruited a diverse group of hundreds of patients by effectively communicating complex study protocols, assessing their eligibility and answering their questionsSupported team members during their patient visits when unanticipated issues would arise such as technical difficulties, mitigating delays and establishing smooth trial executionProactively identified and prevented potential protocol deviations by developing a thorough understanding of research protocols, thus ensuring patient safety and data integrityMet database lock timelines by meticulously entering thousands of critical data points into Electronic Data Capture (EDC) systems and promptly responding to queries, contributing to the overall success of global clinical trials

Collect, process, and quality-review clinical trial data of thousands of participants using in-house and third-party data management tools, resulting in the randomization of hundreds of participants around the globeImprove data collection efficiency and decrease data entry errors by designing workflow organizational tools such as an electronic bulletin board and colour-coordinated headings for data management processesEnsure that ICH/GCP guidelines, industry regulations, and sponsor specifications are closely upheld while handling sensitive participant information, reporting incidental findings, and relaying study-specific information to appropriate personnel Liaise with a variety of internal and external stakeholders such as sponsors, medical doctors, project managers, and clinical trial sites to prioritize cases and guarantee the timely delivery of participants’ trial results Support clinical sites in recording procedures and troubleshooting endoscopy imaging issues via telephone and email technical assistance

Conducted literature searches on the current state of calcium imaging to create effective experimental proceduresDetermined the optimal Fura-2 dye concentration to be used in live-cell imaging by performing fluorescence microscopy experiments and quantitatively and qualitatively analyzing the results Prepared weekly study reports and presentations to keep the team up to date with the progress of the research project Carried out wet lab procedures such as tissue culture maintenance, cell staining, and plasmid amplification