Clinical Trial Documentation Associate

Company: BioPharma Services Inc. Position Title: Clinical Trial Documentation Associate Hourly Rate: $53,000 to $55,000 Job Class: Full-time, 40 hours per week Work Location: Onsite (North York) Duties and Responsibilities: * Prepare and maintain the ISF and/or TMF, as applicable, in collaboration with clinic staff, and other applicable departments ensuring the ongoing collection and filing of essential documents using a paper-based, hybrid, or Veeva-based system. * Assist with archiving CSR: * Coordinates, prepares, and submits appropriate documents to the Research Ethics Board for review and approval (e.g., Protocol, Investigators Brochures, Informed Consent Forms, Telephone screens, subject information sheets, and advertisements) * Tracks the approval process and updates study team members on the approval status of all clinical trials * Submits revised and additional materials to the Research Ethics Board (e.g. amendments, advertisements, safety/study status updates, and close out reports) as required * Reviews and files approval documentation from the Research Ethics Board in the ISF and/or TMF and on the Study Specific Directory. * Assist with the compilation, completion, and internal approval process of Regulatory documentation (Qualified Investigator Undertaking, FDA 1572, financial disclosure, etc.) and provide completed Regulatory documentation to Sponsor/CRO for each study. * Compile study documents. * Ensure accurate and complete documentation of all clinic study source documents, case report forms (CRF) and/or forms according to company’s SOP, GCP and other guidelines. * Perform other duties as required. Qualifications: * BSc, BA, or equivalent experience * Administrative experience in clinical trials, * Experience in CRO environment preferably in conduct of Phase I and Bioequivalence studies * Experience in Research Ethics Boards, Investigator Site File (ISF) and Trial Master File (TMF) is an asset. * Experience is preparing the source documents for clinical trials is an asset. * Excellent interpersonal skills and communication skills. * Excellent organization, multi-tasking skills * Attentive to details, good initiative and able to work with changing priorities.

The associate will prepare and maintain essential clinical trial documentation including ISF and TMF files while coordinating submissions to the Research Ethics Board. They are also responsible for ensuring accurate documentation of source records and case report forms in compliance with GCP and company SOPs.

Candidates must hold a BSc, BA, or equivalent experience and possess administrative experience within a clinical trial or CRO environment. Proficiency in managing Investigator Site Files, Trial Master Files, and Research Ethics Board processes is highly preferred.

• Sens de l’organisationSouhaitée
• Souci du détailSouhaitée
• Saisie de donnéesSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Clinical Trials
• Documentation Management
• ISF Management
• TMF Management
• Research Ethics Board Coordination
• Regulatory Documentation
• Source Document Preparation
• GCP Compliance
• SOP Adherence
• Data Entry
• Communication Skills
• Organization
• Multi-tasking
• Attention To Detail
• Veeva
• Phase I Studies
• Informed Consent
• Regulatory Documents
• Ethical Standards And Conduct
• Administrative Functions
• Research
• Brochures
• Communication
• Case Report Forms
• Interpersonal Communications
• Multitasking
• Trial Master File
• Filing

• Healthcare
• Science & Research
• Administrative
• Clinical Documentation Specialist
• Clinical Research Associate
• Biologists, Botanists, Zoologists and Related Professionals
• Clinical Research Coordinators
• Natural Sciences Managers

Formation minimale

Baccalauréat

Expérience minimale

2+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine