Clinical Trial Coordinator (Regulatory) - FSP

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 

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