Job Description

Title: Clinical Trial Associate (CTA)

Business Line: 4-6+ months of Contract

Location: Cambridge, MA

Travel Requirements: Domestic or international travel may be required- approximately 2-3 trips a year depending on study needs

Experience:

• Experience in clinical study environment within CRO or Pharmaceutical company.
• Knowledge of the clinical study environment with a strong theorical or practical administrative organization.
• Scientific background is an asset.

Qualification:

• 3-year degree in a scientific, or clinical or research field and a 1 minimum of 1year relevant work experience in a clinical research/study management environment (academia or pharma or CRO).
• Minimum: 2-year relevant scientific focused degree and a minimum of 2 years relevant work experience within clinical research /study management environment
• Language: English: Strong intermediate level

Key Required Technical Competencies

• In charge of the electronic TMF (and/or paper TMF, if applicable) set-up and administration.
• Manage the clinical study creation and set-up for the country and site binders and the trial milestones.
• Prepare and customize the TMF Oversight plan, TMF Management plan, TMF master index & business rules, according to the clinical study specificities with the CRM/CPM and the Document Owners.
• Inform the appropriate role of all study team members newcomers or departure.
• Ensure the TMF is being maintained up-to-date and all essential documents are appropriately filed in the TMF.
• Perform continuous oversight of the CRO/Ipsen TMF activities, in checking the documents consistency and the respect of the SOP timelines to maintain the TMF data integrity and by communicating this oversight status to all relevant study team members.
• Coordinate the TMF Quality Check (per SOP) with the CRO to ensure the eTMF inspection readiness.
• Coordinate the final TMF reconciliation with the CRM/CPM.
• In charge of archiving the TMF
• Ability to work in a strong regulated environment within a quality management system (QMS)
• Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader)
• Ability to organize and prioritize
• Able to produce work in teams and within a multi-disciplinary environment
• Basic Financial Knowledge- must be able to work with financial tracking tools
• Knowledge of Pharmaceutical Industry R&D
• Good knowledge of the Good Clinical Practices (GCP) or other clinical study regulations

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