Clinical Trial Coordinator-Finance

6 days ago

Montreal Quebec, Québec, Canada Parexel Full time

Parexel is looking for a Clinical Trial Coordinator- FINANCE.


There is an onsite requirement of a minimum of 1 day per week in Kirkland, Quebec.


Job Purpose:

The Clinical Trial Coordinator is responsible for the following:

• 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: may include but not limited to the following


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: Collaborate with finance/budgeting representatives for

• 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

• Comply with required training curriculum

• Complete timesheets accurately as required

• Submit expense reports as required

• Update CV as required

• Maintain a working knowledge of and complies with

Parexel/Client 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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