Clinical Research Coordinator, Clinical Trial Support Unit

2 weeks ago

Saskatoon, Saskatchewan, Canada University of Saskatchewan Full time

Clinical Research Coordinator, Clinical Trial Support Unit

Primary Purpose: The Clinical Research Coordinator's primary purpose is to assist the Principal Investigator and research team in providing research coordination and support. Success in the role requires judgment and decision-making, following procedures and guidelines set by the PI and collaborating with the research team.

Nature of Work: The CRC/CRN reports to the Director of Research and is accountable to the PI. The position coordinates clinical studies within the PI's research program, involving research assistant functions. The incumbent must work under general supervision, with occasional review by the supervisor. Strong communication, organizational, analytical, and problem-solving skills are required. The ability to work well as a team member is critical.

Accountabilities:

  • Coordinates and executes study visits per protocol
  • Ensures per protocol tasks are completed as per the schedule of assessments
  • Ensures a safe environment for research participants and staff
  • Acts as the primary contact and provides 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
  • Maintains organization and proper documentation of research materials
  • Demonstrates a commitment to teamwork and positivity, along with an ability to create and nurture positive working relationships

Duties:

Study Set-up (20%):

  • Participates in site pre-qualification and qualification effort
  • 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

Study Execution (50%):

  • 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

Study Close-out (5%):

  • Prepares and submits case report forms in compliance with SOPs and regulations

Research Administration (25%):

  • Assists with monitoring and ordering of study specific supplies
  • Attends meetings including investigator, site initiation/close out, and monitoring visits
  • Provides general office duties, including distribution of memos and announcements, photocopying, mailing, and faxing

Qualifications:

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

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 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)

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