Research Assistant - Hamilton, Canada - Hamilton Health Sciences

Description

Unit Summary

The McMaster Hemophilia research team conducts clinical research ranging from retrospective database studies to interventional randomized controlled phase II-III- IV trials, including gene 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 (sponsor/monitor/clinical team) on a regular basis through communication.

• Liaise with internal and external collaborators involved with research projects, to develop study agreements, complete regulatory/ethics submissions, and process payments for sites and other collaborators.

• Conduct structured project participant interviews

• Ensure that the relevant research methodology is applied and all research material is handled in accordance with established protocols, policies, and procedures

• 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

• Help coordinate the process of transferring prepared study data to the study sponsor

• 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.

• Help with publications and other study related documentations.

• Perform activities related to major protocol deviations

• Creation of data collection forms/source documents.

• Regular communication with external parties

• Help provide training to staff

• Help provide training to external study staff

• Attend regular meetings prepare minutes and lines of actions.

Temporary position, 35 hours/week. The position is temporary for one year.

Qualifications:
Bachelor's degree in a relevant field of study.
Requires 2 years of relevant experience.

Assets:
Clinical Trial experience.
GCP, TCPS2 training

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 , Ext 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