Tess McGurn
Lead Clinical Research Associate at Calian Health- Claim this Profile
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Bio
Meghan Devereux, EMBA, HBSc
Tess is an exceptional talent. She has a clear sense of self, with a focused and determined ambition towards her career goals. Her meticulous attention to detail has equipped her with strong skill set in the role of CRA. Personable and charismatic, she quickly builds trusting relationships and exudes confidence, captivating her audience. It was a pleasure having Tess report into me and even just being a small part of what will surely be a long and prosperous career for this rising star.
Meghan Devereux, EMBA, HBSc
Tess is an exceptional talent. She has a clear sense of self, with a focused and determined ambition towards her career goals. Her meticulous attention to detail has equipped her with strong skill set in the role of CRA. Personable and charismatic, she quickly builds trusting relationships and exudes confidence, captivating her audience. It was a pleasure having Tess report into me and even just being a small part of what will surely be a long and prosperous career for this rising star.
Meghan Devereux, EMBA, HBSc
Tess is an exceptional talent. She has a clear sense of self, with a focused and determined ambition towards her career goals. Her meticulous attention to detail has equipped her with strong skill set in the role of CRA. Personable and charismatic, she quickly builds trusting relationships and exudes confidence, captivating her audience. It was a pleasure having Tess report into me and even just being a small part of what will surely be a long and prosperous career for this rising star.
Meghan Devereux, EMBA, HBSc
Tess is an exceptional talent. She has a clear sense of self, with a focused and determined ambition towards her career goals. Her meticulous attention to detail has equipped her with strong skill set in the role of CRA. Personable and charismatic, she quickly builds trusting relationships and exudes confidence, captivating her audience. It was a pleasure having Tess report into me and even just being a small part of what will surely be a long and prosperous career for this rising star.
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Credentials
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Epidemiology in Public Health Practice Specialization
CourseraNov, 2022- Sep, 2024 -
SOCRA Clinical Research Monitoring Workshop
Society of Clinical Research Associates (SOCRA)Feb, 2020- Sep, 2024 -
Project Management Professional (PMP)
Project Management InstituteJan, 2023- Sep, 2024 -
Certified Clinical Research Professional (CCRP)
Society of Clinical Research Associates (SOCRA)Nov, 2019- Sep, 2024 -
Standard First Aid and CPR C
Canadian Red CrossAug, 2019- Sep, 2024 -
Good Clinical Practice (GCP) - Canada
Collaborative institutional training initiativeMar, 2018- Sep, 2024
Experience
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Calian Health
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Canada
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Hospitals and Health Care
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1 - 100 Employee
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Lead Clinical Research Associate
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Jul 2023 - Present
• Represent Sponsor and CRO in developing partnerships, fostering business growth, and ensuring successful clinical trials. • Collaborate with project management and cross-functional leads to ensure effective study management and achieve project objectives.• Perform site selection, site initiation, interim monitoring and site closure visits.
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Clinical Research Associate
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Jul 2021 - Jun 2023
• Partner with study sites to achieve successful clinical trials. • Perform on-site and remote Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits as a blinded and unblinded monitor. • Provide feedback on study manuals, monitoring plans, informed consent, recruitment materials, monitoring tools, Case Report Forms, and completion guidelines.• Oversee essential documentation as pre GCP, study, and regulatory requirements for a complete Investigator Site Files (ISFs) and Trial Master File (TMF).• Establish site recruitment plans and track implementation to promote on-time enrollment. • Ensure proper handling, accountability, and reconciliation of all investigational products. Show less
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Everest Clinical Research
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Canada
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Clinical Research Associate
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Nov 2020 - Jul 2021
• Successfully manage Clinical Trials at both the site and study level.• Develop and review study manuals, monitoring plans, informed consent, recruitment materials, monitoring tools, Case Report Forms, and completion guidelines.• Identify, select, and monitor study sites through to study closeout.• System manager for eTMF and CTMS. Experience includes system selection/implementation/training, and SOP process development/implementation. • Mentored Clinical Trial Assistants. • Create and maintain study budget projections and invoices. • Contribute to the preparation and completion of Requests for Proposals and Bid Defenses. • Support sites and sponsors through internal audits and regulatory inspections. Show less
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Clinical Trial Assistant
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Jan 2019 - Oct 2020
• Establish interdepartmental processes and norms within a growing Clinical Operations functional team to ensure efficient clinical trial management.• Grow the company’s brand with Sponsors to obtain repeat business and attract top talent. • Monitor Clinical Trial Sites, with a focus on compliance and documentation.• Expertise in CTMS and TMF management and document review.• Support general study and project management across all aspects of clinical trials.
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Clinical Research/Administrative Assistant
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May 2017 - Dec 2018
• Developed skills across multiple functional departments including Clinical Operations, Data Management, Medical Writing, Quality Assurance, and Office Management. • Trained in Election Data Capture Systems: Oracle InForm, Medidate Rave, iDataFax, ClinPlus.• Organized various events from Investigators' Meetings and Sponsor Audits to Employee Events.
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Legislative Page
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Nov 2008 - Dec 2008
Followed strict protocol to ensure the smooth running of business conducted in the House of Commons Ensured safe transportation of official documents to public officials Required to be self-regulated and managerial over time management within the House of Commons Concurrent education whilst attending the Page program, self-regulated Followed strict protocol to ensure the smooth running of business conducted in the House of Commons Ensured safe transportation of official documents to public officials Required to be self-regulated and managerial over time management within the House of Commons Concurrent education whilst attending the Page program, self-regulated
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Education
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University of Fredericton
Master of Business Administration - MBA, Business Administration and Data Analytics -
McMaster University
Graduate Certificate, Clinical Research -
McMaster University
Honours Bachelor's Degree, Biology and Psychology -
Maynooth University
Biology, General Psychology, Irish studies -
University of Toronto
Project Management