Clinical Research Associate

Unit Summary

The Juravinski Hospital and Cancer Centre (JHCC) serves more than 1.7 million people in Central West Ontario. The JHCC includes the Juravinski Cancer Centre (JCC), an academic cancer center seeing more than 7500 new cancer patients each year. The JCC provides consultation and specialized assessment, treatment, follow-up and urgent care for cancer patients. Services include comprehensive programs in systemic and radiation therapy, surgical oncology, malignant hematology and supportive care. Affiliated with McMaster University in Hamilton, the JHCC is one of Canada’s largest research and teaching cancer facilities.

The Clinical Trials enterprise at the JCC is an internationally recognized oncology research program dedicated to advancing cancer research through the conduct of phase I to IV clinical trials across all disease sites. Clinical trials personnel are integral members of a multidisciplinary team, working closely with clinicians, researchers, and support staff to ensure comprehensive patient care and research integrity. Known for our early adoption of best practices, the program continually integrates innovative methodologies and technologies to enhance the quality of clinical trials conduct. By streamlining the activation of new studies, and facilitating patient recruitment and participation in clinical research, the JCC Clinical Trials enterprise stands at the forefront of cancer research committed to improving patient outcomes and making significant contributions in the fight against cancer.

Position Summary

The Clinical Research Associate (CRA) assists the research team by performing delegated study tasks for academic and pharmaceutical sponsored clinical trials with significant responsibility for data management. The CRA is responsible for extracting patient information from the electronic health record (EHR) and accurately and efficiently entering data into the sponsor provided electronic data capture (EDC) system. The CRA asks questions to clarify issues related to data integrity, and applies knowledge of internal policies and procedures and national research regulations and guidelines to ensure research activities are carried out in a compliant manner. The CRA communicates patient-specific and/or protocol compliance issues to the Research Coordinator and Investigator, as applicable. The CRA may coordinate and manage minimal risk, non-invasive and/or non-interventional clinical trials from activation to close out, adhering to the study protocol and requlatory requirements including entering study required patient assessment findings in the EHR within scope of practice. Performs other administrative duties as required.

Schedule Work Hours

Monday to Friday; days.

Qualifications

• Bachelor’s degree in a health or science-related discipline required
• Clinical Research Graduate Certificate preferred
• Certification as a Clinical Research Professional (SoCRA or ACRP) an asset
• 1-2 years previous related experience; Clinical research experience preferred
• Knowledge of medical terminology required
• Analytical thinking and problem solving skills
• Excellent written and verbal communication skills
• Knowledge of ICH-GCP guidelines, Health Canada Food and Drug Regulations, and Tri-Council Policy Statement 2 (TCPS-2)
• Basic knowledge of clinical research principles, practices, and processes related to project management, study coordination, regulatory requirements, data collection and reporting
• Highly proficient computer skills
• Experience using electronic health records and data management software applications preferred
• Ability to organize workload to meet deadlines and flexible when priorities change
• Ability to push/pull carts with patient charts/case reports
• Follows health and safety policies and procedures to ensure a safe workplace for self and others

Hamilton Health Sciences fosters a culture of patient and staff safety, whereby all employees are guided by our Mission, Vision, Values, and Values Based Code of Conduct. Hamilton Health Sciences is a teaching hospital and all staff and physicians are expected to support students and other learners.

To be considered for this opportunity applicants must apply during the posting period. All internal and external applicants may ONLY apply via the Careers website. This job posting is for an existing vacancy.

Hamilton Health Sciences is an equal opportunity employer and we will accommodate any needs under the Canadian Charter of Rights and Freedom, Accessibility for Ontarians with Disabilities Act and the Ontario Human Rights Code. Hiring processes will be modified to remove barriers to accommodate those with disabilities, if requested. Should any applicant require accommodation through the application processes, please contact Human Resources at 905-521-2100, Ext. 46947 for assistance. If the applicant requires a specific accommodation because of a disability during an interview, the applicant will need to advise the hiring manager when scheduling the interview and the appropriate accommodations can be made.

This competition is open to all qualified applicants, however, qualified internal applicants will be considered first. Past performance will be considered as part of the selection process. If you are a previous employee of Hamilton Health Sciences, please note: the circumstances around an employee's exit will be considered prior to an offer of employment. Proficiency in both Official Languages, French and English, is considered an asset.