Edna K.

Experience

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  Management Sciences for Health and McMaster University

  Oct 2002 - Mar 2003

  Research Intern
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  Sunnybrook Health Sciences Centre

  Sept 2003 - Jul 2010

  Senior Clinical Research Coordinator

  I was the rimary lead for managing study budgets, study enrollment, patient retention, and protocol adherence. Led study activities from start-up to close-out with staff supervisory duties.Key Contributions:Implemented global clinical trials at 80 sites in 20 countries requiring 2 to 5-year follow-up. Developed training manuals, SOPs, and streamlined data management processes.

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  Susan G. Komen for the Cure

  Sept 2010 - Dec 2012

  Senior Program Specialist

  I specialized in community health research, orchestrating the planning and execution of 122 national breast cancer community profiles.Key Contributions:• Provided expert guidance on statistical and qualitative data collection techniques and conducted thorough health systems analysis

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  American Heart Association | American Stroke Association

  Jan 2013 - Jun 2018

  I was responsible for recruiting and managing a research team, providing mentorship, and implementing performance management techniques that focused on finding solutions. I led project management efforts by coordinating feasibility assessments, site selections, and patient recruitment and retention strategies. I was the principal lead in study-specific monitoring activities and data management solutions.Key Contributions:• Developed and implemented operational study Standard Operating Procedures (SOPs) and training modules.• Elevated to manage clinical registry research study operations and budgets, overseeing studies across two hundred sites with fund allocation exceeding $10 million. Show less As a project manager, I oversaw the planning of various research study project from start-up to closeout. This included the hiring and onboarding of study personnel. I also facilitated important meetings with stakeholders and provided regular updates on the project's progress. I negotiated contracts with vendors and participating sites to obtain essential study tools. Additionally, I coordinated investigator meetings and organized site engagement activities to enrollment and patient retention.Key Contributions:• Advanced to spearhead operations of inaugural AHA/ASA-led trials, overseeing site recruitment, regulatory compliance, IRB processes, training initiatives, and site activation. Show less

  • Senior Clinical Research Programs Manager, Healthcare Quality

    Oct 2015 - Jun 2018

  • Clinical Research Programs Manager, Healthcare Quality

    Mar 2014 - Oct 2015

  • Program Manager, Hospital Accreditation, Healthcare Quality

    Jan 2013 - Mar 2014
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  Cencora

  Jun 2018 - Jun 2024

  I designed unique study methodologies in response to Requests for Proposals (RFPs) and new company growth prospects. I oversaw high-quality clinical operations and services, which have earned accolades from sponsor clients and resulted in recurring business. I managed customer and vendor relationships and provide a solution-focused approach. I direct the team to produce high-quality outputs.Key Contributions:• Managed team personnel, offered mentorship, nurtured development, and fostered growth opportunities.• Achieved and surpassed study performance metrics by accomplishing a 92% enrollment target ahead of schedule, exceeding a 70% patient follow-up retention rate, and consistently delivering client satisfaction levels over 95%. Show less I oversaw the study's scope, timeframes, and budget management, as well as the assessment of key performance metrics. I was the team leader for data monitoring and quality process improvement solutions. Completed the 2021 AmerisourceBergen People Manager leadership training program.Key Contributions:• Promoted to lead the clinical operations team for end-to-end study startup, conduct, and closeout phases.• Independently led global multi-site studies including regulatory, site management, and data quality. Show less I streamlined the development of protocols, managed study budgets, and supervised timelines. I oversaw staff, facilitated a smooth transition to a new CTMS system, and maintained good relationships withvendors. I conducted thorough site feasibility assessments and managed site selection processes, qualification procedures, initiation activities, and monitoring visits.Key Contributions:• Formulated study Informed Consent Forms (ICFs), Case Report Forms (CRFs), Standard Operating Procedures (SOPs), and maintained regulatory documents and the Trial Master File (TMF). Show less

  • Associate Director - Clinical Operations

    Nov 2023 - Jun 2024

  • Assistant Director - Clinical Operations

    Sept 2022 - Nov 2023

  • Senior Manager - Clinical Operations

    Sept 2021 - Sept 2022

  • Manager - Clinical Operations

    Jun 2018 - Sept 2021
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  Premier Inc.

  Jun 2024 - now

  Principal, Research Sciences

  Develop and execute a strategic vision for expanding research capabilities by designing innovative solutions that leverage data sources for business development. Drive client relationships in collaboration with business development and establish strong partnerships with internal stakeholders. Lead talent development, manage performance, and provide coaching and mentorship to the team.Focus:• Ensure scientifically valid and feasible project outcomes.• Meet client expectations for data and deliverables.• Oversight of content deliverables and project scope.• Provide research guidance and thought leadership. Show less