Clinical Trial Coordinator (Regulatory) - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is seekingClinical Trial Coordinators to join our team inCanada! 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

TheClinical Trial Coordinatorsupports 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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