Clinical Research Coordinator I

University Health NetworkToronto, ON
CA$73,069 - CA$91,347Onsite

About The Position

The Clinical Research Coordinator I (CRC I) is a key position in the Cardiotoxicity (Cardio-Oncology) Prevention Program supported by Clinical Trials and Translation Unit (CTTU) within the Peter Munk Cardiac Centre (PMCC). CRC I will play a crucial role in operationalizing cutting edge research including a multi-site trial ongoing in the program. We are looking for a forward thinking and enthusiastic professional to join our team and be a part of many of the innovative initiatives and clinical trials at local, national and international stage. Interested applicant must be willing to work on-site full time. The CRC I will report to the Director of Cardio-Oncology Program and to the Clinical Research Manager of the CTTU.

Requirements

  • At minimum Bachelor’s degree, or recognized equivalent, in a health or science-related discipline
  • 3 years clinical and/or professional experience
  • Minimum 2 year clinical research experience and experience with patient contact
  • Proven and demonstrable expertise in budgeting and research financials management is required
  • Knowledge of research regulations and guidelines, such as ICH/GCP guidelines, Tri-Council Policy, Declaration of Helsinki and FDA CFR and Health Canada TPD
  • Knowledge of investigational product development process (e.g. drugs/biologics, devices, natural health products, etc.)
  • Excellent written and verbal communication skills
  • Excellent interpersonal and customer service skills
  • Strong organizational and time management skills
  • Ability to work well independently as well as part of a team; self-motivated
  • Strong analytical and problem solving skills
  • Proficiency with MS Office software (Outlook, Word, Excel, PowerPoint)

Nice To Haves

  • Cardiology experience in a clinical/research setting, especially in advanced heart failure, is strongly preferred and will be an asset
  • Recognized certification in clinical research (through ACRP or SoCRA e.g. CCRP) preferred
  • TDG (Transportation of Dangerous Goods) certification preferred
  • Knowledge of IATA (International Air Transport Association) shipping regulations and basic laboratory procedures an asset

Responsibilities

  • Executing requirements at local site level and start-up activities at the sub-site level for the multi-site trial
  • Recruitment of study participants (e.g. identifying, screening potential participants and obtaining informed consent)
  • Executing/coordinating all aspects of patient study visits as per study protocol (e.g. source documentation including adverse events and medications, administration of questionnaires, sample processing and shipping, etc.)
  • Implementing and coordinating all aspects of data management including data collection, data entry into CRFs, and source documentation, as per UHN policy and ICH/GCP guidelines
  • Study financial management, oversight and budgeting
  • Execution of study-related administrative tasks
  • Reviewing and assessing study-related documents
  • Participate in internal and external monitoring (and audits) and quality assurance activities
  • Prepare study status reports for investigators and CTTU management
  • Submissions to the Research Ethics Board and other regulatory agencies as required
  • Liaising with sub-site teams as lead coordinator (sponsor rep), external stakeholders and members of the clinical care team(s)

Benefits

  • Competitive offer packages
  • Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP)
  • Close access to Transit and UHN shuttle service
  • A flexible work environment
  • Opportunities for development and promotions within a large organization
  • Additional perks (multiple corporate discounts including: travel, restaurants, parking, phone plans, auto insurance discounts, on-site gyms, etc.)
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