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Clinical Research Site Manager

2 months ago

Hamilton, Ontario, Canada Premier Clinical Trial Network (PCTN) Full time

Join the innovative team at Premier Clinical Trial Network (PCTN) as a Clinical Research Site Manager. In this essential position, you will be responsible for overseeing our advanced clinical research operations, ensuring the successful execution of trials within our state-of-the-art facility. This role merges hands-on research management with strategic oversight, allowing you to lead a dedicated team and drive the success of our research initiatives.

Qualifications

  • Education: A Bachelor's degree in biomedical sciences, public health, nursing, or a related discipline is required. An advanced degree is preferred but not mandatory.
  • Certification: Certification from a recognized clinical research organization (e.g., SoCRA, ACRP) is essential, or must be obtained within the first year of employment.
  • Experience: A minimum of three years in clinical research is required, including experience with ethics board submissions, reporting, source document management, and trial oversight. Familiarity with site feasibility assessments and inventory management is also necessary.
  • Regulatory Knowledge: A solid understanding of regulatory standards, ICH GCP (E.6) principles, and biomedical research ethics is crucial.
  • Skills: Exceptional interpersonal, communication, and organizational abilities are required. You should be adept at collaborating with various stakeholders, including professional staff, sponsors, and regulatory bodies. Proficiency in financial oversight and reporting is also important.

Responsibilities

As the Clinical Research Site Manager, you will lead the research activities at our site, ensuring the seamless conduct of clinical trials. You will act as a senior Clinical Research Coordinator, supervising junior staff and managing key operational aspects, including financial management and regulatory compliance.

Key Duties

Study Management:

  • Evaluate study feasibility based on site resources and budget considerations.
  • Gain a comprehensive understanding of study protocols.
  • Develop and maintain essential study documentation and supplies.
  • Implement effective subject recruitment and retention strategies.
  • Collaborate with the Principal Investigator and study team on protocol reviews.

Regulatory Compliance:

  • Ensure adherence to ICH-GCP guidelines and ethical standards.
  • Manage all ethics submissions from initial application through to study closure.
  • Maintain complete and organized regulatory documentation.
  • Prepare for and facilitate quality assurance audits and inspections.

Financial Management:

  • Monitor and track financial transactions related to clinical trials.
  • Oversee site financial operations and ensure accurate invoicing.
  • Report on the financial status of ongoing studies and future projections.

Subject Management:

  • Screen and enroll participants in accordance with study protocols.
  • Ensure compliance with informed consent procedures.
  • Coordinate participant visits and necessary procedures.
  • Document participant compliance with study requirements.

Data Management:

  • Ensure accurate data entry and timely resolution of queries.
  • Conduct quality control checks to maintain data integrity.
  • Maintain comprehensive source documentation.
  • Address findings from monitoring visits promptly.

Safety Monitoring:

  • Document and report adverse events in line with protocol requirements.
  • Ensure participant safety and welfare throughout the study.

Inventory Management:

  • Oversee the management of clinical trial supplies and equipment.
  • Coordinate the procurement of necessary site supplies.
  • Monitor storage conditions for investigational products.

Team Leadership:

  • Mentor and guide junior staff in their roles.
  • Conduct regular team meetings to discuss study progress.
  • Ensure all team members receive appropriate training.

Communication:

  • Act as the primary liaison for sponsors and regulatory representatives.
  • Provide updates to the Principal Investigator on study developments.
  • Maintain effective communication with the executive team.

Performance Monitoring:

  • Track performance metrics for the site and individual team members.
  • Identify areas for improvement and implement necessary changes.
  • Provide regular performance reports to management.

Additional responsibilities may be assigned as needed.

Job Types: Full-time, Permanent

Benefits:

  • Dental care
  • Extended health care
  • Vision care

Schedule:

  • Monday to Friday

Experience:

  • Clinical research: 3 years (required)

Work Location: In person