Parexel is looking for a Clinical Trial Coordinator- FINANCE.
There is an onsite requirement of a minimum of 1 day per week in Kirkland, Quebec.
Job Purpose:
The Clinical Trial Coordinator is responsible for the following:
• Supports the Clinical Research Manager and other team members through the life
cycle of the study from study start up to study closure
Key Accountabilities: may include but not limited to the following
Trial and site administration
• Tracking (e.g., essential documents) and reporting (e.g., Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases and trackers
• Clinical supply & non-clinical supply management, in collaboration with other
country roles
• Manage Labeling requirements and coordinate/sign translation change
request
Document management
• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents
• Assist with electronic Trial Master File reconciliation
• Updating manuals/documents (e.g., patient diaries, instructions
• Document proper destruction of clinical supplies
• Prepare Investigator trial file binders
• Execute electronic Trial Master File Quality Control Plan
• Obtain translations of documents
Regulatory & Site Start Up responsibilities
• Provide to and collect from investigators forms/lists for site
evaluation/validation, site start-up and submissions in a timely
manner
• Obtain, track and update study insurance certificates
• Support preparation of submission package for Institutional
Review Board / Ethics Review Committee and support
regulatory agencies submissions
• Publish study results for Global Clinical Trial Operations and
Regulatory Affairs where required per local legislation
Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for
• Development of country and site budgets (including Split site budget)
• Tracking and reporting of negotiations
• Maintenance of tracking tools
• Working knowledge of contract development, negotiation,
approval, and maintenance (e.g., Clinical Trial Research Agreements)
• Updating and maintenance of contract templates (in cooperation with Legal
Department)
• Payment calculation and execution (investigators, vendors, grants)
• Ensuring compliance with financial procedures
• Monitoring and tracking adherence and disclosures
• Budget closeout
• Obtain and process Foreign Corrupt Practices Act 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 where applicable)
Compliance with Parexel Standards
• Comply with required training curriculum
• Complete timesheets accurately as required
• Submit expense reports as required
• Update CV as required
• Maintain a working knowledge of and complies with
Parexel/Client processes, ICH-GCPs and other
applicable requirements
Skills:
• Fluent in Local Languages and business proficient in English (verbal and written)
and excellent communication skills
• 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 MS office, use of some clinical IT applications on computer) and ability to adapt
• to new IT applications. Strong MS Excel skills required
• International Council for Harmonization ‐ Good Clinical Practice knowledge appropriate to role
• 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
• Able to work independently
• Proactive attitude to solving problems / proposing solutions
• Positive mindset, growth mindset, capable of working independently with assigned tasks
• Contributes to Clinical Trial Coordinator team knowledge by acting as buddy /mentor and sharing best
practices as appropriate/required
Knowledge and Experience:
• Minimum 1-2 years in Clinical Research or relevant healthcare experience
Note – Specific experience requirements may vary depending on the Country
Education:
• Bachelor’s degree (Life Sciences preferred) or equivalent healthcare experience
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