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Site Lead

3 months ago

Hamilton Ontario EH, Ontario, Canada Premier Clinical Trial Network Full time

Join our cutting-edge clinical research team as a Site Lead in our newly constructed, purpose-built research suite. Located directly across from Hamilton General Hospital, this pivotal role combines hands-on research coordination with strategic leadership. You'll oversee critical studies, mentor a dedicated team, and drive our site's success in this unparalleled setting. If you're an experienced clinical research professional ready to shape the future of medical research in a groundbreaking environment, this is your opportunity to make a lasting impact.

Qualifications

  • Training: Bachelor's degree in biomedical sciences, public health, nursing, or a related field. Advanced degree preferred but not required.
  • Certification: Certification by a recognized clinical research association (e.g., SoCRA, ACRP) required, or to be completed within one year of employment.
  • Experience: Minimum of three years of experience in clinical research, including experience with REB submissions, reporting, source document creation and editing, and trial management. Experience with site feasibility assessments, IRB/ethics submissions, and inventory management is required.
  • Regulatory and GCP Knowledge: Strong understanding of regulatory requirements, ICH GCP (E.6) principles, PCTN SOPs/WPs, and biomedical research ethics.
  • Skills: Excellent interpersonal, communication, and organizational skills. Ability to work effectively with professional and administrative staff, sponsors, regulatory representatives, patients, and potential subjects. Proficiency in financial management and reporting.

Responsibility

Under the direction of the Principal Investigator and PCTN executive team, lead the site's research activities, ensuring the smooth conduct of clinical trials. Serve as a senior Clinical Research Coordinator while overseeing junior CRCs and managing key site operations, including financial aspects, regulatory submissions, and inventory management.

Duties

Study Preparation and Management:

  • Assess study feasibility considering site resources, budget, and potential challenges
  • Develop in-depth understanding of study protocols
  • Create and maintain source documents and study supplies
  • Develop and implement subject recruitment and compliance strategies
  • Review protocols with the Principal Investigator and study team

Regulatory Compliance and Documentation:

  • Maintain adherence to ICH-GCP, PCTN SOPs/Work Instructions, and biomedical research ethics
  • Manage IRB/ethics submissions from initial trial application to close out
  • Ensure all regulatory documentation is complete and appropriately filed in ISF
  • Prepare for and manage quality assurance audits and sponsor or regulatory inspections

Financial Operations:

  • Track income and expenses related to clinical trials
  • Manage and reconcile site finances
  • Ensure timely and accurate invoicing for study activities
  • Report on financial health of ongoing studies and future projections

Subject Management:

  • Screen and enroll study subjects according to protocol criteria
  • Ensure compliance with proper informed consent process
  • Schedule and coordinate subject visits and procedures
  • Assess and document subject compliance with study requirements

Data Management and Quality Control:

  • Ensure accurate and timely data entry and query resolution into appropriate systems
  • Perform quality control checks for data entry ensuring data integrity with regards to study endpoints
  • Maintain thorough and comprehensive source documentation
  • Conduct on-site quality checks and address monitor findings

Safety Monitoring and Reporting:

  • Monitor and document adverse events as per protocol requirements
  • Facilitate prompt reporting of serious adverse events to appropriate parties
  • Ensure study participants' safety and welfare throughout the trial

Inventory and Supply Management:

  • Oversee site inventory, including clinical trial supplies and equipment
  • Coordinate procurement of essential site supplies
  • Manage investigational product storage, dispensing, and accountability
  • Monitor storage conditions of IP and biological specimens

Team Leadership and Training:

  • Mentor and train junior CRCs
  • Assist in onboarding and training new research staff
  • Conduct regular team meetings to discuss study progress and challenges
  • Ensure proper study-related training for all team members

Stakeholder Communication:

  • Serve as primary point of contact for sponsors and regulatory representatives
  • Provide regular updates to the Principal Investigator on study progress
  • Maintain open communication with the PCTN executive team

Performance Monitoring and Improvement:

  • Track key performance metrics for the site and individual CRCs
  • Identify areas for improvement and implement action plans
  • Provide regular performance updates to management

Additional tasks as agreed upon by the employee and PCTN.

Job Types: Full-time, Permanent

Benefits:

  • Dental care
  • Extended health care
  • Vision care

Schedule:

  • Monday to Friday

Ability to commute/relocate:

  • Hamilton, ON L8L 5G4: reliably commute or plan to relocate before starting work (required)

Experience:

  • clinical research: 3 years (required)

Work Location: In person

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