Job Title: Clinical Research Coordinator V
Location: Toronto, ON
Duration: 6 months

Position Summary
The Clinical Research Coordinator V is responsible for performing a variety of clinical procedures to collect, record, report, and interpret data on patients enrolled in or seeking enrollment in clinical studies. This role ensures all activities are conducted in accordance with study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements. The incumbent will also assist with daily workload planning and provide support to research investigators and study teams.Key Responsibilities
Clinical Research Support

• Provide clinical research support to investigators in the preparation and execution of assigned research studies.
• Review study protocols, Case Report Forms (CRFs), study-specific documents, and electronic data capture systems.
• Attend and participate in all relevant study meetings.
• Collect and submit regulatory and ethics documentation required by the FDA and other governing regulatory bodies.
• Recruit and screen potential participants for clinical trials and maintain subject screening logs.
• Educate research subjects regarding study objectives, procedures, timelines, and protocol requirements.
• Design and maintain source documentation in accordance with protocol requirements.
• Schedule and conduct study visits and perform required study procedures.

Data Collection & Management

• Collect, record, and maintain research subject data in accordance with study protocols and SOPs.
• Ensure data quality, accuracy, completeness, and regulatory compliance.
• Assist with data quality reviews and resolution of data queries.
• Record, report, and interpret study findings appropriately to support development of study-specific databases.

Clinical Procedures
Perform a variety of complex clinical research procedures, including but not limited to:

• Electrocardiograms (ECGs)
• Sample collection and processing
• Spirometry testing
• Vital signs assessment
• Dose verification
• Cannulation
• Cardiac telemetry monitoring

Laboratory & Subject Safety

• Manage laboratory testing and specimen logistics, including preparation of collection materials.
• Monitor subject safety and promptly report adverse events or reactions to appropriate medical personnel.
• Communicate with study participants and address study-related questions or concerns.

Study Coordination & Compliance

• Participate in daily team huddles to ensure study tasks are assigned and completed according to expected standards.
• Assist investigators in ensuring study objectives are met on schedule, within budget, and in compliance with regulatory requirements and quality standards.
• Prepare for and participate in study monitoring visits, audits, and regulatory inspections.
• Support research site staffing and scheduling coverage planning.

Training & Mentorship

• Train new investigator site staff on study-specific requirements and procedures.
• Maintain compliance with site staff training requirements through auditing and record maintenance.
• Support ongoing adherence to training and regulatory standards.

Required Knowledge, Skills, and Abilities

• Knowledge of clinical trial processes and methodologies.
• In-depth understanding of departmental, protocol-specific, and study-specific operating procedures.
• Knowledge of informed consent processes and study schedules.
• Familiarity with medical terminology.
• Proficiency with Microsoft Windows and Microsoft Office applications, including:
  • Outlook
  • Excel
  • Word
  • Access
• Excellent interpersonal and communication skills.
• Strong attention to detail and organizational abilities.
• Ability to establish and maintain effective working relationships with investigators, colleagues, managers, clients, and study participants.
• Ability to manage multiple priorities in a fast-paced clinical research environment.

Minimum Education & Experience

• High School Diploma or equivalent required.
• Bachelor's degree in a scientific or healthcare-related field is considered an asset.
• Relevant work experience in a clinical environment, medical setting, or clinical research environment.
• Equivalent combinations of education, training, and experience may be considered.
• Applicable certifications and licenses as required by the company, province, country, or regulatory authorities.

Preferred Qualifications

• Prior experience coordinating clinical trials.
• Working knowledge of Good Clinical Practice (GCP) guidelines.
• Experience with electronic data capture (EDC) systems.
• Experience supporting regulatory audits and inspections.
• Ability to train and mentor junior staff members.

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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 55.00/hr.