Research Project Coordinator I - Hamilton
Hamilton Health Sciences Hamilton
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.
Respsonsibilties 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). 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.
Respsonsibilties 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). 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 Framemaker, iDataFax, TrialMaster, or RedCAP.
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