Clinical Research Assistant(I)
City : Hamilton
Category : Other
Industry : Education
Employer : McMaster University
Should the successful applicant be a Unifor Unit 1 bargaining unit member, who meets the eligibility conditions of Article 19.02 of the Unifor Unit 1 Collective Agreement, then the Limited Term Assignment will be defined as a Career Growth Opportunity in accordance with Article 19 of the Unifor Local 5555 Unit 1 Collective Agreement.
McMaster University, Faculty of Health Sciences (FHS), is a leader in health research and innovation, providing a dynamic and collaborative environment for researchers and professionals. The largest Faculty within McMaster, has an unwavering commitment to collaboration, strategic partnerships, accountability, innovation, excellence, integrity and optimism. Our pioneering approaches to education and our reputation for world-class research has consistently placed McMaster among the Top 40 universities in the world for health and medicine. The Faculty enjoys close relationships with its academic hospital partners, as well as strong collaborations with researchers in Canada and around the world.
Trials Research and Clinical Evidence (TRACE) Unit:
The Trials Research and Clinical Evidence (TRACE) Unit, https://www.tracetrials.ca, previously the Ontario Clinical Oncology Group (OCOG), is located within the Faculty of Health Sciences, Department of Oncology. TRACE was recently launched to expand beyond the work of oncology. TRACE is an academic-based clinical trials development and coordination organization. TRACE works with investigators to conceive, design, coordinate, conduct, analyze and publish early and late phase clinical trials. Together with a network of local, provincial, national and international clinician investigators, TRACE addresses clinically relevant questions, with the ultimate goal to impact and improve patient care.
Inspiring and Guiding New Investigators in Trails Excellence (IGNITE) Program:
Inspiring and Guiding New Investigators in Trials Excellence (IGNITE) program brings together a dynamic cohort of investigators across diverse specialties (radiation, medical, surgical oncology and haematology) and career stages to design and implement high-quality clinical trials. The program includes: 1) faculty group mentorship, 2) collaborative iterative, intellectual meetings for sharing progress, refining research and solving problems, and 3) research support to success as trialists.
These two strategic initiatives, TRACE and IGNITE, represent investments in our department's clinical research with significant long-term impact potential. IGNITE will cultivate the next generation of clinical trialists through structured mentorship and collaborative research support. Simultaneously, the TRACE restructuring expands our proven clinical trials capabilities beyond oncology into diverse therapeutic areas, positioning us as a comprehensive trials unit.
Job Summary:
Reporting to the TRACE Associate Director, the Clinical Research Assistant is responsible for:
Overall support of the ongoing transition from OCOG to TRACE, including but not limited to:
- Supporting TRACE leadership, PIs, Collaborators, Committee members, Vendors, Site Investigators and trial personnel, internal personnel and other stakeholder communications
- Updating of all current OCOG Policies, SOPs, Templates and Checklists, Administrative and organizational documents to reflect the change to TRACE
- Update of information with all external partners and institutions
- Creating and maintaining electronic files and folders with tracking of implementation of revisions
- Review of social media and website linkages currently listing OCOG – to communicate necessary revisions
- Tracking of existing ‘OCOG’ trials including projected/actual timelines for completion
- Financial reporting and tracking
- Maintaining and organizing components of research project budgets, monthly operational expenses and clinical site payments
- Exercising appropriate budget controls, monitoring and reconciling accounts
- Involvement in the collection, verification, management and reporting of clinical trial data
- Gather and compile information and data required for reports and disseminate data to research groups and collaborating partners.
Overall support of the IGNITE Program including:
- Program coordination, communication, and meeting planning
- Support for clinical investigators (members) of the IGNITE program
- Conducting comprehensive literature searches and maintaining databases of relevant papers
- Data management of smaller projects that are required in preparation of clinical trial proposals e.g. retrospective reviews, surveys, site feasibility
- Project coordination – management of project timelines, coordination of meetings with collaborators, handling ethics submissions, preparation of grant submissions etc
- Technical support – compiling background information for grant applications, formatting proposals, aiding with the submission of publications.
Additional Skills:
- Possess excellent interpersonal, oral and written communication skills.
- Utilizing existing Electronic Data Capture (EDC) systems for the collection, verification of study data.
- Ability to work in a team environment and the ability to work with a wide range of internal and external stakeholders.
- Computer literacy with advanced skills in Office 365, online meeting platforms and clinical trials management systems.