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Clinical Trial Associate (Science & Biotech)
ANYWHERE USA, NC 27560
Recruited by: Sheryl Horowitz | Recruiter | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Dec 22, 2021
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Job Description

Our client, a mid-sized privately owned clinical research organization, is looking for a full-time,, homebased Clinical Trial Associate to join their team!

• Supports project teams in the planning, execution, control, reporting and closure of clinical projects according to the company's SOPs and established project-specific plans.
• Establishes, maintains, QCs and transfers eTMF/TMF/project files per SOPs and project-specific plans.
• Establishes, provides access to, maintains and updates required information for assigned projects in the CTMS and other designated project tools, systems or databases, as assigned.
• Provides training and support to project team members and sponsor personnel on project-specific systems and tools.
• Serves as a liaison between clinical trial sponsor(s), the project team, investigational sites, and project vendors, as assigned.
• Serves as Start-up Specialist, as assigned, performing the following duties:
o Assists with development of project-specific plans, forms, tools and templates.
o Sets up project-specific tools and portals (e.g., CORE, Sharepoint, CTMS).
o Assists with site identification and site feasibility assessments.
o Supports central IRB/EC submission of clinical research protocols, as requested.
o Reviews Informed Consent Form (ICF) templates proposed by clinical sites during IRB/EC submission to confirm consistency with project-specific template and required elements, as requested by PM or CTM.
o Provides project-specific essential document templates to selected sites.
o Collects, monitors and QCs completed site-specific essential documents per approved TMF Management Plan, Site Activation Plan and other project specifications.
o Prepares Green Light Packages per Site Activation Plan and/or other project specifications.