Lead Clinical Research Coordinator

3 weeks ago

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

Join our innovative clinical research organization as a Clinical Research Site Manager. In this essential position, you will be responsible for overseeing our state-of-the-art research facility, ensuring the effective execution of clinical trials. This role merges practical research management with strategic oversight, allowing you to lead a talented team and contribute significantly to our mission of advancing medical research.

Qualifications

  • Education: A bachelor's degree in biomedical sciences, public health, nursing, or a related discipline is required. An advanced degree is advantageous but not mandatory.
  • Certification: Must possess certification from a recognized clinical research association (e.g., SoCRA, ACRP) or be willing to obtain it within the first year of employment.
  • Experience: A minimum of three years in clinical research is essential, with expertise in REB submissions, reporting, source document management, and trial oversight. Familiarity with site feasibility assessments, IRB/ethics submissions, and inventory control is necessary.
  • Regulatory Knowledge: A solid grasp 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 patients. Proficiency in financial oversight and reporting is also necessary.

Responsibilities

As the Clinical Research Site Manager, you will lead the research initiatives at our site, ensuring the seamless execution of clinical trials. You will act as a senior Clinical Research Coordinator, guiding junior CRCs and managing key operational aspects, including financial management, regulatory compliance, and inventory oversight.

Key Duties

Study Management:

  • Evaluate study feasibility based on site resources and potential obstacles.
  • Gain a comprehensive understanding of study protocols.
  • Develop and maintain essential study documents and supplies.
  • Formulate and implement strategies for subject recruitment and compliance.
  • Collaborate with the Principal Investigator and study team to review protocols.

Regulatory Compliance:

  • Ensure adherence to ICH-GCP, PCTN SOPs, and ethical standards in biomedical research.
  • Oversee IRB/ethics submissions from initiation to closeout.
  • Maintain complete and organized regulatory documentation in the Investigator Site File (ISF).
  • Prepare for and manage quality assurance audits and inspections.

Financial Management:

  • Monitor income and expenses related to clinical trials.
  • Manage site finances and ensure accurate invoicing for study activities.
  • Report on the financial status of ongoing studies and future projections.

Subject Management:

  • Screen and enroll participants according to protocol criteria.
  • Ensure compliance with the informed consent process.
  • Coordinate subject visits and necessary procedures.
  • Document subject compliance with study requirements.

Data Management:

  • Ensure timely and accurate data entry and resolve queries in the appropriate systems.
  • Conduct quality control checks to maintain data integrity.
  • Keep thorough source documentation and address monitor findings.

Safety Monitoring:

  • Document adverse events as required by the protocol.
  • Facilitate the prompt reporting of serious adverse events.
  • Prioritize the safety and welfare of study participants throughout the trial.

Inventory Management:

  • Oversee site inventory, including clinical trial supplies and equipment.
  • Coordinate the procurement of essential supplies.
  • Manage the storage and accountability of investigational products.

Team Leadership:

  • Mentor and train junior CRCs.
  • Assist in onboarding new research staff.
  • Conduct regular team meetings to discuss study progress.

Communication:

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

Performance Monitoring:

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

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