Clinical Trial Coordinator

Job Description

Under the oversight of the line manager, this role is responsible for comprehensive trial and site administration. It involves preparing, collating, distributing, and archiving clinical documents. The Clinical Trial Coordinator (CTC) supports clinical and non-clinical supply management and ensures the timely update of tracking and reporting tools, as applicable.

This role is essential for meeting planned site preparation dates, including assisting with the preparation of submission packages for the Research Ethics Board/Institutional Ethics Committee (REB/IEC) and health authorities. The incumbent will collaborate closely at the local level with the Clinical Operations Manager (COM), the Clinical Research Manager (CRM), and the Clinical Research Associate (CRA). The person also collaborates with finance/budget representatives to manage Clinical Trial Research Agreements (CTRA) and payments.

Responsibilities include, but are not limited to:

• Trial and site administration:

• Track (e.g., essential documents) and report (e.g., safety reports)

• Ensure the gathering and distribution of study tools and documents

• Update clinical trial databases (Clinical Trial Management System) and trackers

• Manage clinical and non-clinical supplies, in collaboration with other national roles

• Manage labeling requirements and coordinate/sign translation change requests, in collaboration with other national roles (if applicable)

• Document management:

• Prepare documents and correspondence

• Gather, distribute/ship, and archive clinical documents, e.g., the electronic Trial Master File (eTMF)

• Assist with the reconciliation of the electronic Trial Master File (eTMF)

• Execute the quality control plan for the electronic Trial Master File (eTMF)

• Update manuals/documents (e.g., patient diaries, instructions)

• Document the proper destruction of clinical supplies.

• Prepare investigator site file binders

• Regulatory and site start-up responsibilities: Collaborate with other national roles to:

• Provide and collect forms/lists for the site from investigators in a timely manner

• Obtain, track, and update forms required by Health Canada;

• Support the preparation of the submission package for the Research Ethics Board/Institutional Ethics Committee (REB/IEC) and support submissions to regulatory agencies.

• Budgeting, agreements, and payments

• Collaborate with finance/budget representatives

• Develop, monitor, update, and close out national and site budgets (including shared site budgets)

• Track and report contract negotiations

• Update and maintain contract templates (in cooperation with the legal department)

• Calculate and execute payments (to investigators, vendors, grants)

• Ensure compliance with financial and compliance procedures

• Monitor and track adherence and disclosures

• Maintain tracking tools

• Obtain and process FCPA documentation in a timely manner

• Meeting planning:

• Organize meetings (create and track study memos/letters/protocols)

• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

Skills:

• Fluency in French is required

• Good understanding of global, national/regional clinical research guidelines and the ability to work in compliance with these guidelines.

• Practical knowledge of Good Documentation Practices

• Good computer skills (use of Microsoft Office, use of certain clinical computer applications) and the ability to adapt to new computer applications. Strong Microsoft Excel skills are required.

• Knowledge of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines appropriate to the role

• Excellent negotiation skills

• Effective time management, organizational and interpersonal skills, conflict management

• Effective communication with external clients (e.g., sites and investigators)

• Strong sense of responsibility/urgency. Ability to set priorities and manage multiple tasks simultaneously in a changing environment

• Works effectively in a multicultural matrix environment. Ability to establish and maintain culturally sensitive working relationships.

• Demonstrates a commitment to customer focus, both internally and externally.

• Able to work independently

• Proactive attitude to solving problems/proposing solutions

• Positive mindset, growth mindset

Experience requirements:

• Experience in clinical research or other healthcare experience with a desire to develop further is an asset.

Education requirements:

• Completed B.A./B.S. (Life Sciences preferred).

This job posting is for an existing vacancy.

The anticipated base salary range for this position is $66,880 - $100,320 CAD. At our company, we are firmly committed to providing fair compensation for comparable work and experience, which is a fundamental part of our organizational culture. Individual employee compensation is based on several factors, including relevant experience, skills, and proficiency level, as well as other legitimate factors related to appropriate internal comparators.

We put people at the heart of our priorities. This position is eligible for our discretionary short-term incentive program, which fosters a pay-for-performance culture. Additionally, our total rewards and benefits programs go beyond traditional plans (medical and retirement) to create a flexible and inclusive workplace that supports employee well-being, development, and long-term success.

We may use artificial intelligence and automated tools to support our recruitment process. These tools are used to support, not replace, human judgment. All hiring decisions are made by our hiring managers.

We are proud to be a company that values the contribution of diverse, talented, and committed individuals. The fastest way to foster innovation is to bring together diverse ideas in an inclusive environment. We encourage our colleagues to respectfully challenge each other's perspectives and solve problems collectively. We are an equal opportunity employer and are committed to fostering an inclusive and diverse workplace.

We encourage applications from all qualified individuals. In accordance with our accommodation policies and applicable provincial and federal accessibility legislation, we are committed to providing reasonable accommodations throughout the recruitment process.

Required Skills:

Accountability, Analytical Problem Solving, Clinical Data Management, Clinical Information Systems, Clinical IT, Clinical Research, Clinical Site Management, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Clinical Trial Support, Data Analysis, Drug Regulatory Affairs, Electronic Trial Master File, ICH GCP Guidelines, Institutional Review Board (IRB), Medical Records Management, Project Management, Regulatory Compliance, Site Initiation, Supply Management

Preferred Skills:

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Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The clinical trial coordinator (CTC) supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.

The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to Institutional Review Board/Institutional Review Committee (IRB/ERC) and Health Authorities. The role will collaborate at local level closely with the Clinical Operations Manager (COM), Clinical Research Manager (CRM) and Clinical Research Associate (CRA). And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.

Responsibilities include, but are not limited to:

• Trial and site administration:

• Track (e.g. essential documents) and report (e.g. Safety Reports)

• Ensure collation and distribution of study tools and documents

• Update clinical trial databases (Clinical Trial Management System) and trackers

• Clinical supply & non-clinical supply management, in collaboration with other country roles

• Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)

• Document management:

• Prepare documents and correspondence

• Collate, distribute/ship, and archive clinical documents, e.g. electronic Trial Master File (eTMF)

• Assist with electronic Trial Master File (eTMF) reconciliation

• Execute electronic Trial Master File Quality Control Plan

• Update manuals/documents (e.g., patient diaries, instructions)

• Document proper destruction of clinical supplies.

• Prepare Investigator trial file binders

• Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

• In a timely manner, provide to and collect from investigators forms/lists for site

• undefined

• Obtain, track and update Health Canada required forms;

• Support preparation of submission package for the Institutional Review Board/Institutional Review Committee (IRB/ERC) and support regulatory agencies submissions.

• Budgeting, Agreement and Payments:

• Collaborate with finance/budgeting representatives

• Develop, control, update and close-out country and site budgets (including Split site budget)

• Track and report contract negotiations

• Update and maintain contract templates (in cooperation with Legal Department)

• Calculate and execute payments (to investigators, vendors, grants)

• Ensure adherence to financial and compliance procedures

• Monitor and track adherence and disclosures

• Maintain tracking tools

• Obtain and process FCPA 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 vendor where applicable)

Skills:

• Fluency in French is required

• 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 Microsoft office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong Microsoft Excel skills required.

• Knowledge of the International Conference on Harmonisation Good Clinical Practices (ICH-GCP) appropriate to role

• Excellent negotiation skills

• 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, both internally and externally.

• Able to work independently

• Proactive attitude to solving problems / proposing solutions

• Positive mindset, growth mindset

Experience Requirements:

• Experience in Clinical Research or other healthcare experience with a desire to develop further is an asset

Educational Requirements:

• Completed B.A./B.S. (Life Science preferred)

This job posting is for an existing vacancy position .

The anticipated base salary range for this position is $66,880 - $100,320 CAD. At our company, we are firmly committed to provide fair and equitable pay for similar work and experience as a fundamental aspect of our workplace culture. Individual employee salaries will be based on several factors such as relevant experience, skills & proficiency, and/or other bona fide factors relative to appropriate internal comparators.

At our Company, we lead with people. This role includes eligibility to our discretionary short-term-incentive plan which fosters a pay-for-performance culture. Also, our contemporary rewards and benefit programs go beyond traditional medical plans and retirement programs, to create a flexible, inclusive workplace to support employee well-being, development and long-term success.

We may use artificial intelligence and automated tools to support our recruitment process. AI tools are used to support, but not replace, human judgment. All hiring decisions are made by our hiring managers.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

We encourage applications from all qualified candidates. In accordance with our accommodation policies and applicable provincial and federal accessibility legislation, we are committed to providing reasonable accommodation throughout the recruitment process.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

08/29/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.