Description:
Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing, and archiving clinical documents. The clinical trial coordinator (CTC) supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
This role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to Institutional Review Board/Institutional Review Committee (IRB/ERC) and Health Authorities. The role will collaborate at the local level closely with the Clinical Operations Manager (COM), Clinical Research Manager (CRM), and Clinical Research Associate (CRA). And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.
Responsibilities include, but are not limited to:
Trial and site administration:
Track (e.g. essential documents) and report (e.g. Safety Reports)
Ensure collation and distribution of study tools and documents
Update clinical trial databases (Clinical Trial Management System) and trackers
Clinical supply & non-clinical supply management, in collaboration with other country roles
Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)
Document management:
Prepare documents and correspondence
Collate, distribute/ship, and archive clinical documents, e.g. electronic Trial Master File (eTMF)
Assist with electronic Trial Master File (eTMF) reconciliation
Execute electronic Trial Master File Quality Control Plan
Update manuals/documents (e.g., patient diaries, instructions)
Document proper destruction of clinical supplies.
Prepare Investigator trial file binders
Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:
In a timely manner, provide to and collect from investigators forms/lists for site
Obtain, track and update Health Canada required forms;
Support preparation of submission package for the Institutional Review Board/Institutional Review Committee (IRB/ERC) and support regulatory agencies submissions.
Budgeting, Agreement, and Payments:
Collaborate with finance/budgeting representatives
Develop, control, update, and close-out country and site budgets (including Split site budget)
Track and report contract negotiations
Update and maintain contract templates (in cooperation with Legal Department)
Calculate and execute payments (to investigators, vendors, grants)
Ensure adherence to financial and compliance procedures
Monitor and track adherence and disclosures
Maintain tracking tools
Obtain and process FCPA documentation in a timely manner
Meeting Planning:
Organize meetings (create & track study memos/letters/protocols)
Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
Skills:
Fluency in French is required
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Hands-on knowledge of Good Documentation Practices
Good IT skills (Use of Microsoft office, use of some clinical IT applications on the computer) and ability to adapt to new IT applications. Strong Microsoft Excel skills required.
Knowledge of the International Conference on Harmonization Good Clinical Practices (ICH-GCP) appropriate to the role
Excellent negotiation skills
Effective time management, organizational and interpersonal skills, conflict management
Effective communication with external customers (e.g. sites and investigators)
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
Demonstrates commitment to Customer focus, both internally and externally.
Able to work independently
Proactive attitude to solving problems / proposing solutions
Positive mindset, growth mindset
Experience Requirements:
Experience in Clinical Research or other healthcare experience with a desire to develop further is an asset
Educational Requirements:
Completed B.A./B.S. (Life Science preferred)
This job posting is for an existing vacancy position.
The anticipated base salary range for this position is $66,880 - $100,320 CAD. At our company, we are firmly committed to providing fair and equitable pay for similar work and experience as a fundamental aspect of our workplace culture. Individual employee salaries will be based on several factors such as relevant experience, skills & proficiency, and/or other bona fide factors relative to appropriate internal comparators.
At our Company, we lead with people. This role includes eligibility for our discretionary short-term incentive plan which fosters a pay-for-performance culture. Also, our contemporary rewards and benefit programs go beyond traditional medical plans and retirement programs to create a flexible, inclusive workplace to support employee well-being, development, and long-term success.
We may use artificial intelligence and automated tools to support our recruitment process. AI tools are used to support, but not replace, human judgment. All hiring decisions are made by our hiring managers.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
We encourage applications from all qualified candidates. In accordance with our accommodation policies and applicable provincial and federal accessibility legislation, we are committed to providing reasonable accommodation throughout the recruitment process.
