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Finance • mirabel qc
Clinical Trial Coordinator- Finance FSP
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Maverick FXSalluit, QCClinical Trial Coordinator- Finance FSP
ParexelRemote, Quebec, Canada- Temps plein
- Télétravail
When our values align, there's no limit to what we can achieve.
Parexel FSP is looking for a Clinical Trial Coordinator - Finance.
This position is a hybrid position with 1-day minimum onsite requirement in Kirkland, Quebec. Experience in Site Payments and Budgets Required.
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 :
Primary Responsibilities :
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.
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.
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.
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.
o Organize meetings (create & track study memos / letters / protocols).
o Support local investigator meetings (invitations, prepare materials, select venue, support where applicable).
Education and Certification :
Skills and Experience :
Language Skills :
LI-SS1