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 looking for a Clinical Trial Coordinator with experience with budget negotiation.
This position is a hybrid position with 1-day minimum onsite requirement in Kirkland, Quebec.
Job Title: Clinical Trial Coordinator (CTC)
Position Purpose: The Clinical Trial Coordinator (CTC) is responsible for the following:
• Supports the Clinical Research Manager (CRM) and other team members through the life cycle of the study from study start up to study closure.
Organizational Relationships:
• Reports to Parexel assigned Line Management with day-to-day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure.
Primary Responsibilities:
• Trial and site administration:
o Tracking (e.g., essential documents) and reporting (e.g., Safety Reports).
o Ensure collation and distribution of study tools and documents.
o Update clinical trial databases (CTMS) and trackers.
o Clinical supply & non‐clinical supply management, in collaboration with other country roles.
o Manage Labeling requirements and coordinate/sign translation change request.
• Document management:
o Prepare documents and correspondence.
o Collate, distribute/ship, and archive clinical documents.
o Assist with electronic Trial Master File (eTMF) reconciliation. o Updating manuals/documents (e.g., patient diaries, instructions).
o Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders.
o Execute eTMF Quality Control Plan.
o Obtain translations of documents.
• Regulatory & Site Start Up responsibilities:
o Provide to and collect from investigators forms/lists for site evaluation/validation, site start‐up and submissions in a timely manner.
o Obtain, track and update study insurance certificates.
o Support preparation of submission package for Institutional Review Board (IRB) / Ethics Review Committee (ERC) and support regulatory agencies submissions.
o Publish study results for Global Clinical Trial Operations (GCTO) and Regulatory Affairs (RA) where required per local legislation.
• Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:
o Development of country and site budgets (including Split site budget).
o Tracking and reporting of negotiations.
o Maintenance of tracking tools.
o Working knowledge of contract development, negotiation, approval, and maintenance (e.g., Clinical Trial Research Agreements (CTRAs)).
o Updating and maintenance of contract templates (in cooperation with Legal Department)
o Payment calculation and execution (investigators, vendors, grants
o Ensuring compliance with financial procedures.
o Monitoring and tracking adherence and disclosures.
o Budget closeout.
o Obtain and process Foreign Corrupt Practices Act (FCPA) documentation in a timely manner.
• Meeting Planning:
o Organize meetings (create & track study memos/letters/protocols).
o Support local investigator meetings (invitations, prepare materials, select venue, support where applicable).
• Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.
• Adheres to EP and Client SOPs and processes.
Education and Certification:
• B.A./B.S. (Life Sciences preferred) or equivalent healthcare experience.
Skills and Experience:
• Minimum 1-2 years in Clinical Research or relevant healthcare experience. Note - Specific experience requirements may vary depending on the Country
• 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 Committee on Harmonization (ICH) ‐ Good Clinical Practice (GCP) 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 CTC team knowledge by acting as buddy /mentor and sharing best practices as appropriate/required.
Language Skills:
• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills.
#LI-KW1
Skills Required
- B.A./B.S. degree or equivalent healthcare experience
- Minimum 1-2 years clinical research or relevant healthcare experience
- Knowledge of ICH-GCP
- Hands-on knowledge of Good Documentation Practices
- Strong MS Excel skills and proficiency with MS Office
- Experience with CTMS and electronic Trial Master File (eTMF)
- Experience in budget development, negotiation, tracking and closeout
- Working knowledge of clinical trial contracts (CTRAs) and contract negotiation/maintenance
- Experience with payment calculation/execution and financial compliance (including FCPA documentation)
- Ability to prepare regulatory/IRB/EC submission packages and interact with regulatory agencies
- Effective communication skills in English and local language(s)
- Ability to work independently in a matrix, multicultural environment and manage multiple priorities
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
