Research Assistant

Unit Summary

The Population Health Research Institute (PHRI), a joint institute of Hamilton Health Sciences and McMaster University, with over 300 employees working directly with over 60 researchers.

PHRI conducts clinical research internationally in 102 countries and is a world leader in large, global health and population and health outcomes research.

Our capacity to conduct multiple international studies concurrently, with tens of thousands of participants in each, is a capability very few organizations in the world can match.

Position Summary

The Research Assistant is to provide support to internal and external study contacts in the conduct of all study activities related to clinical trial(s) as well as to develop subject matter expertise to identify trends in all aspects of the study to ensure all standards are met, the clinical trial operates efficiently, and to ensure data quality. Job duties include :

1. Create and test data reports, databases, edit checks, case report forms (CRFs), and related programs, technology, and support tools for efficient collection, analysis, and reporting

2. Troubleshooting and problem-solving issues with study systems, reports, data queries

3. Support Research Coordinator / Program Manager to oversee the management and reporting of data

4. Coordinate logistics, review requirements, and confirm accuracy for the shipping and collection of materials and supplies for the main study as well as for sub-studies

5. Request and review reports from the Statistics and / or ICT Department(s) to maintain data integrity of the study

6. Develop study support tools, reports, and trackers (i.e. manuals, instructional documents)

7. Maintain and manage access to study database and systems for all study personnel

8. Maintain ongoing communication with sites regarding all study related materials and issues to ensure all materials are up to date.

9. Compile and review documentation required for Good Clinical Practice and / or as required from the study sponsor

10. Coordinate drug supply and demand with study sponsor and IP manufacturer, packager, distributor to prevent shortages and overages

11. Perform activities related to major protocol deviations and data transfers

12. Provide training to PHRI and external study staff

13. Implement protocol amendments in consultation with the Research Coordinator / Program Manager

14. Review IP-related information provided on study CRFs. Apply and resolve queries.

15. Provide user access to IP management systems (IVRS / IWRS)

16. Other duties as assigned.

Schedule Work Hours

Monday to Friday - 37.5 hours / week

Qualifications

1. Bachelor’s degree related to Health or Business preferred

2. Minimum of 2 years of data management and research / clinical trials experience

3. Proficient in Microsoft Office Suite

4. Ability to problem-solve, work independently, adapt to constant change, take initiative, self-motivate, be flexible, and multi-task

5. Excellent communication (written and verbal) and interpersonal skills

6. Familiarity with electronic data capture software and data authoring software such as iDataFax, Framemaker, MedDRA, RedCap, SAS Visual Analytics

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

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.

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 HR Operations 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