Clinical Trials Associate

3 weeks ago

Hamilton, Ontario, Canada Hamilton Health Sciences Full time

Unit Overview

The Clinical Trials Department at Hamilton Health Sciences is a leading oncology research program recognized globally. Our research encompasses various phases of therapeutic, supportive care, and non-therapeutic studies. The clinical trials team plays a vital role in the multi-disciplinary approach, ensuring patient engagement and participation in clinical research.

Position Overview

The Clinical Research Associate (CRA) is tasked with the organization, administration, and coordination of clinical research activities. This role involves meticulous documentation to uphold the quality and integrity of clinical trial data. The CRA establishes a systematic approach for data management and aids in monitoring compliance with study protocols.

Key Responsibilities

  • Oversee all facets of the clinical trial process, including initiation procedures, patient screening for eligibility, and protocol registration.
  • Conduct patient interviews, monitor participants throughout the study, and manage data collection and submission.
  • Respond to inquiries related to the clinical trials.

Work Schedule

Standard work hours are Monday to Friday.

Qualifications

  1. Completion of a Community College Secretarial/Office Administrative Diploma Program (preferably in Medical/Health Services) or equivalent.
  2. A minimum of three (3) years of recent experience in an oncology-related setting.
  3. At least two (2) years of recent clinical research experience or an equivalent educational qualification in clinical research.
  4. Preferred certifications include Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP).
  5. In-depth knowledge of International Conference on Harmonisation Good Clinical Practice (ICH GCP), Health Canada Food and Drug Regulations, and US FDA Code of Federal Regulations.
  6. Familiarity with cancer, human anatomy and physiology, diagnostic tests, treatment modalities, and associated side effects.
  7. Certification in medical terminology (Levels 1 & 2 or equivalent).
  8. Proficiency in MS Office and database applications, with a strong understanding of CRF and eCRF completion processes.
  9. Exceptional analytical skills with a keen attention to detail.
  10. Strong interpersonal and communication skills, both written and verbal.
  11. Excellent organizational abilities, demonstrating motivation and self-direction.
  12. Proven skills in patient assessment, education, and counseling.
  13. Ability to prioritize tasks and manage multiple responsibilities concurrently.
  14. Willingness to travel between sites to support off-site investigators conducting oncology studies.
  15. Typing proficiency of 45 words per minute (subject to testing).
  16. Outstanding problem-solving and critical thinking abilities, with a capacity to identify issues and seek solutions as necessary.

Additional Information

As a condition of employment, proof of full COVID-19 vaccination is required. Hamilton Health Sciences promotes a culture of safety for patients and staff, guided by our Mission, Vision, Values, and Values-Based Code of Conduct. As a teaching hospital, all staff and physicians are expected to support students and other learners.

This opportunity is open to all qualified candidates, with internal applicants being considered first. Past performance will be a factor in the selection process. Proficiency in both official languages, French and English, is considered an asset.

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