The McMaster Adult Hemophilia research team conducts clinical research ranging from retrospective database studies to interventional randomized controlled phase II-III- IV trials, including gene editing therapy. Our mission is to advance our understanding of hemophilia and bleeding disorders through research and contribute to the improvement of hemophilia care.

• Support Research Coordinator to oversee the operation and management of research projects.

• Adhere to Good Clinical Practice and incorporate GCP requirements in all stages of research projects from start up to close up.

• Adhere to regulatory and local requirements (i.e. annual safety reports, periodic safety reports).

• Adhere to timelines and milestones.

• Provide support to all collaborators (sites, countries, CROs, Sponsors) on a regular basis through communication.

• Liaise with internal and external collaborators involved with research projects, to support logistics of daily operations.

• Compile, review, and file essential documents

• Help with training and orientation of study sites and staff.

• Help develop Manual of Operations and other study support tools, reports, and trackers.

• Help create and test data reports, databases, audit case report forms (CRFs), and related programs

• Respond to data-related questions and query from internal and external partners

• 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.

• Prepare for meetings and teleconferences

• Implement all study related amendments requested by the Principal Investigator

• Respond to daily inquiries and facilitate communications on behalf of the central site.

• Perform activities related to major protocol deviations

• Regular communication with external parties

• Help provide training to external study staff

• Prepare and attend regular meetings, manage and document summary of minutes and lines of action(s).

• Support the study coordinator in the design of required study management plans required for the conduct of the research study (e.g., data management plan, monitoring plan, adjudication plan, investigational product (IP) management plan, safety management plan, etc.)

• Assist with initial, annual and project amendment ethics committee submissions

• Support with the design, development and implementation of study REDCap database, and other required study systems. (i.e. Randomization, websites, etc.)

• Design of the study database, case report forms and required edit checks, in accordance with protocol and study requirements

• Support with routine monitoring of regular data collection activities, including quality control reports, data entry and data review/validation using pre-existing or newly created reports

Temporary part-time, 20 hours/week.

This position is temporary until June 2027.

• Bachelor's degree in a relevant field of study, or related experience equivalent. Requires 2 years of relevant clinical trial experience. GCP Certificate.

• Excellent communication skills.

Assets

• TCPS2 training, experience and knowledge of REDCap database build and maintenance

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 ***-***-**** 🔒 Premium, 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