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Primary Purpose: The Clinical Research Coordinator's primary purpose is to proficiently assist the Principal Investigator and associated research team through providing research coordination and support. This individual will also assist with administrative duties in relation to CTSU Studies. Success in the role will require some judgment and decision making, following procedures and guidelines set by the Director, PI and research team.

Nature of Work: The CRC reports to the Director of Research and is accountable to the PI for the studies they coordinate. The position involves some research assistant functions within the research program in addition to administrative duties associated with CTSU services. The incumbent must be capable of working under general supervision subject to occasional review by the supervisor. The ability to effectively work through complex issues and concerns with low to moderate stress resulting from work pressure is necessary. Strong communication, organizational, analytical, and problem-solving skills are required. The ability to work well as a team member is critical to the role. The position may involve field work and irregular hours, such as weekend and evening work.

Accountabilities

  • Acts as the primary contact and provides administrative and coordination support for research
  • Establishes and maintains strong working relationships with participants, researchers, and other study personnel; Liaises between study sponsors, staff, investigators and the CTSU
  • Ensures per protocol tasks are completed as per the schedule of assessments
  • Maintains organization and proper documentation of research materials
  • Ensures a safe environment for research participants and staff
  • Demonstrate a commitment to teamwork and positivity, along with an ability to create and nurture positive working relationships.

Duties

Research Administration

  • Provides accurate operational support for potential new studies, confidential correspondence, annual reports, contracts, proposals and regulatory documents.
  • Assists with the distribution and preparation of correspondence (mail, email and courier deliveries) and with the filing and retention of paper-based and electronic information.
  • Assists with the collection, preparation, review and submission of regulatory documents.
  • Assists with completion and maintenance of records in the Clinical Trial Management System (CTMS)
  • Attends meetings including investigator, site initiation/close out, and monitoring visits
  • Completes general office duties, including distribution of memos and announcements, photocopying, mailing, and faxing

Study Coordination - Set-up, Execution, & Close-out

  • Participates in site pre-qualification and qualification efforts
  • Ensures all required approvals are in place prior to enrollment
  • Assists in planning, implementation, and coordination of data collection
  • Recruits research participants and conducts eligibility assessment
  • Coordinates and conducts study visits and procedures per protocol
  • Obtains informed consent and conducts baseline testing
  • Maintains informed consent and oversees participant retention and compliance
  • Creates and maintains accurate patient source documents ensuring GCP
  • Participates in Health Canada inspections and sponsor audits
  • Prepares periodic and special reports, manuals, and correspondence
  • Prepares and submits case report forms in compliance with SOPs and regulations

Qualifications

Education and Experience: A Bachelor's Degree in a health-related field with 2 years of experience in clinical research. A Master's Degree in a health-related field would be considered an asset.

Required Skills:

  • Proficiency with Microsoft Office (Word, Excel, Outlook)
  • Excellent verbal and written communication skills
  • Strong organizational, time, and project management skills
  • Experience conducting patient-oriented research
  • Excellent interpersonal skills and ability to collaborate with team members
  • Detail oriented and able to exercise initiative and good judgement

Training: The following certifications are required prior to commencing any study related procedures

  • TCPS2 Core Course
  • Safety Orientation for Employees (USask)
  • Off-Campus Activity Safety Plans (USask)
  • Canada GCP (CITI)
  • Clinical Research Coordinator (CITI)
  • Health Canada Division 5 (CITI)
  • Protocol Specific SOPs (N2)

Department: Clinical Trial Support Unit

Status: Term 2 years with the possibility of extension or becoming permanent

Employment Group: ASPA

Shift: Mon-Fri, 8:00-4:30

Full Time Equivalent (FTE): 1.0

Salary: The salary range, based on 1.0 FTE, is $49,301.00 - 77,033.00 per annum. The starting salary will be commensurate with education and experience.

Salary Family (if applicable): Specialist Professional

Salary Phase/Band: Phase 1

Posted Date: 9/23/2022

Closing Date: 9/29/2022

Number of Openings: 1

Work Location: May be eligible for hybrid work under the terms of USask's Alternative Workspace Guidelines

The successful applicant will be required to provide the following current verification(s) where 'Yes' is indicated below. Further information is available at: https://careers.usask.ca/tips-for-applying.php

Criminal Record Check: Yes

Driver's License and Abstract Check: Not Applicable

Education/Credential Verification: Not Applicable

Vulnerable Sector Check: Not Applicable

Please review the University of Saskatchewan's health and safety requirements for faculty, staff and students in consideration of the COVID-19 pandemic.

The University believes equity, diversity, and inclusion strengthen the community and enhance excellence, innovation and creativity. We are dedicated to recruiting individuals who will enrich our work and learning environments. All qualified candidates are encouraged to apply; however, in accordance with Canadian immigration requirements, Canadian citizens and permanent residents will be given priority. We are committed to providing accommodations to those with a disability or medical necessity. If you require an accommodation in order to participate in the recruitment process, please notify us and we will work together on the accommodation request. The University of Saskatchewan's main campus is situated on Treaty 6 Territory and the Homeland of the Métis. We pay our respects to the First Nations and Métis ancestors of this place and reaffirm our relationship with one another. Together, we are uplifting Indigenization to a place of prominence at the University of Saskatchewan.

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