Clinical Research Coordinator, Administrator

**Clinical Research Coordinator, Administrator**:
**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.
Success in the role will require some judgment and decision making, following procedures and guidelines set by the PI and collaborating with the research team. The role will be comprised of 70% study coordination of independently assigned research projects and 30% assisting in administrative study coordination with CTSU Clinical Research Nurses (CRNs).

**Accountabilities**:

- Provides effective and efficient services and support to clinical investigators
- 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
- Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts
- Maintains organization and proper documentation of research materials as per regulatory requirements
- Ensures a safe environment for research participants and staff
- Demonstrates a commitment to teamwork and positivity, along with an ability to create and nurture positive working relationships.

**Duties (70% Independent Study Coordination / 30% Assisting Nurse Coordination)**:
Study Set-up
- Participates in site pre-qualification and qualification efforts
- Ensures all required approvals are in place prior to enrollment
- Ensures all documentation both electronic and physical is in place before enrollment
- Assists in planning, implementation, and coordination of data collection
- Recruits research participants and conducts eligibility assessment

Study Execution
- Coordinates and conducts study visits and procedures per protocol
- Obtains informed consent and conducts baseline testing
- Maintains and organizes study data forms, ensuring high standards of data quality and control
- Enters data into relevant databases and assists with data management
- Participates in Health Canada inspections and sponsor audits
- Prepares periodic and special reports, manuals, and correspondence
- Assists in the storage and distribution of study samples for analyses

Study Close-out
- Prepares and submits case report forms in compliance with SOPs and regulations
- Ensures proper long-term storage of study materials is arranged with investigators

Research Administration
- Assists with monitoring and ordering of study specific supplies and devices
- Attends meetings including investigator, site initiation/close out, and monitoring visits
- Collects documentation as required for above listed meetings
- Provides general office duties, including distribution of memos and announcements, photocopying,
- mailing, and faxing
- Prepares participant follow-up communication as needed per study

**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 communication skills and ability to collaborate with team members
- Detail oriented and able to exercise initiative and good judgement
- Handle all patient interactions with tact, discretion, confidentiality, cultural sensitivity.

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, College of Medicine
**Status**: Term 2 years with the possibility of extension or becoming permanent
**Employment Group**: Research Positions - Non-union
**Shift**: Monday-Friday, 8:00-4:30
**Full Time Equivalent (FTE)**: 1.0
**Salary**:The starting salary will be commensurate with education and experience.
**Salary Phase/Band**:Salary Band 6
**Posted Date**: 12/3/2024
**Closing Date**: 12/9/2024 at 6:00 pm CST
**Number of Openings**:1
**Work Location**:On Campus