Parexel
Clinical Trial Coordinator- Finance- FSP
Canada-Quebec-Remote
Sponsorship not specifiedDetected 5 days ago
GCPCRMNegotiationBudgetingExcelClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationCollaborationTime ManagementMicrosoft OfficeGxPRegulatory Affairs
About the role
- 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.
Responsibilities
- o Support preparation of submission package for Institutional Review Board (IRB) / Ethics Review Committee (ERC) and support regulatory agencies submissions.
- o Tracking (e.g., essential documents) and reporting (e.g., Safety Reports).
- o Ensure collation and distribution of study tools and documents.
- 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 Obtain translations of documents.
Requirements
- o Working knowledge of contract development, negotiation, approval, and maintenance (e.g., Clinical Trial Research Agreements (CTRAs)).
- o Publish study results for Global Clinical Trial Operations (GCTO) and Regulatory Affairs (RA) where required per local legislation.
- Parexel FSP is looking for a Clinical Trial Coordinator with experience with budget negotiation.
Skills
- Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills.
- o Update clinical trial databases (CTMS) and trackers.
- o Clinical supply & non‐clinical supply management, in collaboration with other country roles.
- 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.
- Effective time management, organizational and interpersonal skills, conflict management.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
- Demonstrates commitment to Customer focus.
- Able to work independently.
- Proactive attitude to solving problems / proposing solutions.
Benefits
- At Parexel, we all share the same goal - to improve the world's health.
Company info
- When our values align, there's no limit to what we can achieve.
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This listing is sourced directly from Parexel's careers page and normalized into a canonical job model.