Clinical Trial Coordinator-Finance

1 week ago

Montréal QC, 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 lifecycle of the study from study start up to study closureKey Accountabilities: may include but not limited to the followingTrial 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 othercountry roles• Manage Labeling requirements and coordinate/sign translation changerequestDocument 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 documentsRegulatory & Site Start Up responsibilities• Provide to and collect from investigators forms/lists for siteevaluation/validation, site start-up and submissions in a timelymanner• Obtain, track and update study insurance certificates• Support preparation of submission package for InstitutionalReview Board / Ethics Review Committee and supportregulatory agencies submissions• Publish study results for Global Clinical Trial Operations andRegulatory Affairs where required per local legislationBudgeting, 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 LegalDepartment)• 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 timelymannerMeeting 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 withParexel/Client processes, ICH-GCPs and otherapplicable requirementsSkills:• 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 towork 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 taskssimultaneously in a changing environment• Works effectively in a matrix multicultural environment. Ability to establish and maintainculturally 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 bestpractices as appropriate/requiredKnowledge and Experience:• Minimum 1-2 years in Clinical Research or relevant healthcare experienceNote - Specific experience requirements may vary depending on the CountryEducation:• Bachelor’s degree (Life Sciences preferred) or equivalent healthcare experience

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    1 week ago

    Montréal, QC, 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 lifecycle of the study from study start up to study closureKey...

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