Clinical Trial Coordinator (Regulatory) - FSP

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I contribute to clinical research with expertise and empathy. And I do it

Overview

As a part of the global Project Leadership group at Parexel, you are responsible for leading cross-functional teams to deliver high-quality and patient-focused clinical trials and help bring life-changing treatments to market faster. You collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets. The role requires strong leadership and communication skills, the ability to work under pressure, and a passion for improving patients' lives.

In return, Parexel offers a supportive work environment, and a high degree of empowerment and accountability to lead your studies. Within this role, you work with a diverse set of clients and therapeutic areas, and you are encouraged to take on new challenges and pursue your interests.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

• Adaptable
• Communicator
• Collaborative
• Leadership
• Proactive
• Problem-solver

About This Role

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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Potential Career Path

Parexel offers a growth path with diverse therapeutic areas and clients, so you can grow according to your interests.

Associate Project Leader

Project Leader

Senior Project Leader

Associate Project Director

Project Director

Director, Project Leadership

Senior Director, Project Leadership

Employee Insights

Donata about the team culture and career growth

Donata Juske | Senior Project Leader

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Helen on the diverse work experience

Helen Buttinger | Associate Project Director

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Briar on creating work-life balance

Briar Jallad | Associate Director, Project Management

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Why Project Leaders work at Parexel

Patient-led in everything we do

We lead and drive the success of clinical trials and feel the satisfaction of seeing the positive impact of our work on patients' lives.

Supportive and inclusive environment

We build a culture where relationship building is a priority for the success of our cross-functional teams and our client interaction.

Accountability and growth

We provide Project Leaders with the responsibility and empowerment to turn challenges into achievements and development opportunities.

Flexible work arrangements

We offer remote, in-office and hybrid roles to balance work and personal life depending on your needs.

Varied project experience

We continuously learn from a broad exposure of small biotech or large pharma clients, different therapeutic areas and innovative trial design.

Career progression

We offer various career paths, including enhancing your position, moving into management, or developing into other areas of the business.

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