Job Description

The Clinical Research Associate (CRA) is responsible for the organization, administration and coordination of assigned clinical research tasks, and completion of documentation to ensure the quality and integrity of the clinical trial data. The CRA maintains a system for effective data flow and assists with monitoring for study compliance. The CRA is involved in all aspects of the clinical trial process including startup procedures, screening and assessing patients for eligibility, registration of patients to protocols, interviewing patients, monitoring patients on study, collection and submission of data, and responding to enquiries.

Qualifications

1. Graduate of Community College Secretarial/Office Administrative Diploma Program (Medical/ Health Services preferred) or equivalent
2. Minimum of three (3) years recent experience in an oncology-related environment
3. Minimum two (2) years recent (within last 5 years) clinical research experience or equivalent educational diploma/ certificate in clinical research (i.e., Clinical Trials Management Diploma (University of Western), Clinical Research Certificate (Humber College), Clinical Research Associate Certificate (McMaster University))
4. Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP) and/ or equivalent certification is preferred
5. Demonstrated knowledge of International Conference on Harmonisation Good Clinical Practice (ICH GCP), Health Canada Food and Drug Regulations, and the US FDA Code of Federal Regulations
6. Working knowledge of cancer, human anatomy and physiology, diagnostic and pathologic tests results, cancer
treatments and side effects, and disease-related symptoms
7. Medical terminology certificate (Levels 1 & 2 or equivalent subject to testing)
8. Highly proficient in MS Office and data base applications (e.g. Demonstrated knowledge of CRF and eCRF completion
processes)
9. Strong analytical skills with particular attention to detail
10. Demonstrated positive interpersonal and communication skills (written and verbal)
11. Excellent organizational skills, with a high degree of motivation and self-directedness
12. Demonstrated ability in patient assessment, teaching and counseling
13. Demonstrated ability to prioritize workload and perform multiple concurrent tasks
14. Ability to travel between HHS sites to support off-site investigators conducting oncology studies
15. Ability to type 45 w.p.m. (subject to testing)
16. Exemplary problem-solving and critical thinking skills, with an ability to identify problems and seek additional information, or implement corrective processes, as appropriate

As a condition of employment, you are required to submit proof of full COVID-19 vaccination to Employee Health Services.

Hamilton Health Sciences