Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

Carolyn Solek

Toronto

Overview

6
6
years of professional experience

Work History

Clinical Trial Manager

Alexion
07.2023 - Current
  • Ensuring clinical study document compliance and submission to the TMF throughout Periodic Quality check (PQC) reviews and creations of Clinical Study Report (CSR) appendices
  • Maintaining 6 global studies in Phase 1
  • Ensuring that project documents are maintained per relevant Standard Operating Procedures (SOPs)/Work Instructions (WIs).
  • Maintaining Vendor Oversight Plan, Vendor Accountability Logs and proficient in editing ICF's as well as budgets
  • Procuring, printing and distributing patient safety cards in multiple languages for use across studies.
  • Serving as CIOMS coordinator to track and update log of investigator letters against Investigator Brochure.
  • Coordinate delivery of documents to support registration of a protocol in
    ClinTrials.gov/EUdract and monitor its update throughout a study.
  • Act as central point of contact for vendor providing this service.
  • Entering, tracking and routing contracts for legal input and approval using business systems and internal work spaces.
  • Upon site closure, preparing subject files, inventories documents, reconciling document discrepancies, and organizing study files for electronic archive and off-site storage.
  • Providing administrative support around and assembly of presentations for Investigator, CRO/vendor kick-off meetings as required.
  • Customizing/updating any study-specific plans and process flows for multiple clinical vendors, as appropriate e.g., site training plan, site monitoring plan, cross functional data review plan, IP release plan etc.

Clinical Trial Assistant 2

IQVIA on behalf of Hoffmann-La Roche
05.2021 - 07.2024
  • Leading Clinical Research Associates and Start-Up Specialist (SUSS) with accurately updating and maintaining 22 studies clinical systems that track site compliance and performance within project timelines, ensuring all sites are compliant to strict guidelines.
  • Collaborating with Neuro-Degen-Immuno-Rare Clinical Operation Lead's (COL) with site start-up process through handling, distribution, filing, and archiving of clinical documentation, reports, ICFs and IRB documents according to the scope of work and standard operating procedures
  • Assists with the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow
  • Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation
  • Performing administrative tasks such as tracking CRA and CTAs trainings, compliance, KPIs and site risk assessments
  • Ensures good document practices to maintain electronic file systems (eTMF and GLG) for studies to be audit ready at all times
  • Assisting in vendor management by performing vendor-set up activities and tracking of patient enrollment
  • Reforming CTA onboarding program, lead of mentoring program and newsletter team

Public Relations Manager

Vivorosa
03.2020 - 05.2021
  • Researched, negotiated, implemented, and tracked advertising and public relations activities
  • Collaborated with other companies to encourage product coverage and promote brand mission and values
  • Created and managed published content for Instagram feed
  • Built relationships with other brand ambassadors and influencers to assist in social media strategy
  • Developed paid client ads for use on diverse social media platforms

Social Media Coordinator

University of Toronto
11.2018 - 05.2019
  • Took photographs and videos of athletes during track meets and relevant practices for social media platforms (Twitter & Instagram)
  • Traveled with the team when requested for further updated photos, videos and status of athlete’s progress on social media
  • Managed the track and field teams Instagram and Twitter accounts by curating posts and stories appropriate to the school’s image
  • Reached out to companies for collaboration opportunities
  • Analyzed engagement of posts and stories to increase following

Education

Bachelor of Kinesiology -

University of Toronto
Toronto, ON
2023

Skills

  • Interpersonal Skills
  • Project Management
  • Collaborative Leadership
  • Cross-functional and creative problem solving
  • TMF Management
  • Good Clinical Practice
  • Mentoring

Accomplishments

  • Barnett Accreditation-Fundamental GCP Accreditation, Version 4, 2021
  • IQVIA Impact Award, 2021
  • Subject Matter Expert (SME) for site communications and follow-up process
  • Subject Matter Expert (SME) for the Shared Investigator Platform and Manual Distribution (MDR)
  • SME of Zycus (legal platform)
  • SME of CIOMS

Timeline

Clinical Trial Manager

Alexion
07.2023 - Current

Clinical Trial Assistant 2

IQVIA on behalf of Hoffmann-La Roche
05.2021 - 07.2024

Public Relations Manager

Vivorosa
03.2020 - 05.2021

Social Media Coordinator

University of Toronto
11.2018 - 05.2019

Bachelor of Kinesiology -

University of Toronto

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Carolyn Solek