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Clinical Study and Regulatory Specialist I

Clinical Study and Regulatory Specialist I

University Health NetworkToronto, Ontario, Canada
30+ days ago
Salary
CA$66,924.00–CA$83,655.00 yearly
Job description

Union : NonUnion

Site :   Princess Margaret Cancer Centre

Department :   Division of Medical Oncology and Hematology Clinical Trials Group

Reports to :    Clinical Research Manager DMOHCTG

Work Model : OnSite

Grade : N0 : 06

Hours :   37.5 hours per week

Salary : $66924 $83655 annually (To commensurate with experience and consistent with UHN compensation policy)

Shifts : Monday Friday

Status :   Permanent Fulltime

Closing Date : February 14 2025

Position Summary

The Clinical Study and Regulatory Specialist I participates in the coordination of clinical trials from protocol activation and follow up to trial closure.

Duties

  • Monitoring and promoting the quality and integrity of data recording clinical trial data in case report forms (CRFs) and compilation of ethics and regulatory documents.
  • The coordination and monitoring of data is performed in accordance with the trial protocol hospital and departmental guidelines and professional standards of practice.
  • Data is assessed compiled recorded and submitted to pharmaceutical companies or used for internal studies.
  • All data must be complete accurate timely and must be in compliance with applicable ICHGCP FDA and US federal code and TriCouncil regulations.
  • Interpret the applicable regulations in order to ensure compliance. Quality assurance procedures are utilized to ensure high quality data is obtained.

Qualifications :

  • At minimum a Bachelors degree in a health or sciencerelated discipline (required)
  • At least two (2) years experience in some or all of Oncology Clinical trials medical terminology regulatory issues involving human subjects
  • At least one (1) year experience in the review and preparation of Health Canada and Research Ethics Board submissions including writing informed consent forms
  • Clinical Research Graduate Certificate (preferred)
  • Demonstrated relevant clinical research knowledge
  • Excellent written and verbal communication skills excellent organization prioritization skills good computer skills ability to learn quickly and work independently
  • Excellent interpersonal skills
  • Ability to work under pressure and attention to detail
  • Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to UHN standards
  • Ability to perform multiple concurrent tasks
  • Knowledge of applicable legislative UHN and / or departmental policies
  • Client service oriented with the ability to effectively work with diversity and appreciate that people with different opinions backgrounds and characteristics bring richness to the challenge or situation at hand
  • Satisfactory attendance
  • Additional Information :

    Why join UHN

    In addition to working alongside some of the most talented and inspiring healthcare professionals in the world UHN offers a wide range of benefits programs and perks. It is the comprehensiveness of these offerings that makes it a differentiating factor allowing you to find value where it matters most to you now and throughout your career at UHN.

  • 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 onsite gyms etc.)
  • Current UHN employees must have successfully completed their probationary period have a good employee record along with satisfactory attendance in accordance with UHNs attendance management program to be eligible for consideration.

    All applications must be submitted before the posting close date.

    UHN uses email to communicate with selected candidates.  Please ensure you check your email regularly.

    Please be advised that a Criminal Record Check may be required of the successful candidate. Should it be determined that any information provided by a candidate be misleading inaccurate or incorrect UHN reserves the right to discontinue with the consideration of their application.

    UHN is an equal opportunity employer committed to an inclusive recruitment process and workplace. Requests for accommodation can be made at any stage of the recruitment process. Applicants need to make their requirements known.

    We thank all applicants for their interest however only those selected for further consideration will be contacted.

    Remote Work : Employment Type :

    Fulltime

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