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

The Research Project Coordinator I provides 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 coordinate the flow of materials and information to permit the conduct of a clinical trial. Responsibilities include: 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; Assist with troubleshooting and problem-solving issues with study systems, reports, data queries;. Support team to oversee the management and reporting of data; Request and review reports from the Statistics and/or ICT Department(s) to maintain data integrity of the study;. Develop and maintain study support tools, reports, and trackers;. Maintain and manage access to study database and systems for all study personnel;. Maintain ongoing communication with sites regarding all study related materials and issues to ensure all materials are up to date; Compile and review documentation required for Good Clinical Practice and/or as required from the study sponsor.
Coordinate drug supply and demand with study sponsor and IP manufacturer, packager, distributor to prevent shortages and overages;. Perform activities related to major protocol deviations and data transfers; Provide training to PHRI and external study staff;. Implement protocol amendments with direction;. Review IP-related information provided on study CRFs. Apply and resolve queries and Provide user access to IP management systems (IVRS/IWRS).

The Research Project Coordinator I provides 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 coordinate the flow of materials and information to permit the conduct of a clinical trial. Responsibilities include: 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; Assist with troubleshooting and problem-solving issues with study systems, reports, data queries;. Support team to oversee the management and reporting of data; Request and review reports from the Statistics and/or ICT Department(s) to maintain data integrity of the study;. Develop and maintain study support tools, reports, and trackers;. Maintain and manage access to study database and systems for all study personnel;. Maintain ongoing communication with sites regarding all study related materials and issues to ensure all materials are up to date; Compile and review documentation required for Good Clinical Practice and/or as required from the study sponsor.
Coordinate drug supply and demand with study sponsor and IP manufacturer, packager, distributor to prevent shortages and overages;. Perform activities related to major protocol deviations and data transfers; Provide training to PHRI and external study staff;. Implement protocol amendments with direction;. Review IP-related information provided on study CRFs. Apply and resolve queries and Provide user access to IP management systems (IVRS/IWRS).

Monday - Friday; 37.5 hours weekly

Monday - Friday; 37.5 hours weekly

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 Framemaker, iDataFax, TrialMaster, or RedCAP.

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 Framemaker, iDataFax, TrialMaster, or RedCAP.

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

If this position is temporary, selection for this position will be as per the outlined Collective Agreements:

Article 30 (k), CUPE Collective Agreement

Article 10.7 (d), ONA Collective Agreement

Article 13.01 (b) (ii), OPSEU 273 Collective Agreement

Article 14.04, OPSEU 209 Collective Agreement

Article 2.07 and Article 13, PIPSC RT Collective Agreement