Clinical Trial Coordinator (Regulatory) - FSP

Parexel; Montreal; Vor Ort; CAD 55.000 - 75.000; Vollzeit

Zusammenfassung

Parexel is seeking a Clinical Trial Coordinator to join our team in Canada. The role supports the life cycle of clinical studies from start-up to close-out, reporting to the Clinical Research Manager and working closely with investigators and teams across sites.

The ideal candidate has 1–2 years in clinical research, is bilingual in English and French, and is willing to visit sponsor offices in Montreal and Kirkland up to twice per week. Strong documentation and budgeting skills are a plus.

Qualifikationen

• 1–2 years in Clinical Research or relevant healthcare experience
• Bilingual in English and French
• Ability to work across a matrix multicultural environment

Aufgaben

• Track essential documents and reporting (Safety Reports) and support life-cycle management
• Prepare, distribute, archive clinical documents and maintain trial master file
• Assist with site start-up, submissions to ethics/regulatory bodies and sponsor oversight
• Develop country/site budgets, track negotiations, and maintain tracking tools
• Plan local investigator meetings and support materials and venues
• Ensure compliance with Parexel standards, training, and timesheets

Kenntnisse

Bilingual English/French

Communication skills

Time management

MS Excel

Documentation practices

Clinical trial coordination

Ausbildung

Bachelor's degree in Life Sciences or healthcare

Tools

MS Office

Clinical IT applications

Jobbeschreibung

Parexel FSP is seeking Clinical Trial Coordinators to join our team in Canada! Candidates should 1-2 years of experience in clinical research, bilingual in english and french and be open to go to sponsor's office in Montreal, Kirkland 2x/week.

Job Summary

The Clinical Trial Coordinator 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

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

• 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

• Complies with required training curriculum
• Completes timesheets accurately and timely as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel 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