Clinical Trial Associate

Job Description:

Job Title: Clinical Trial Associate

Job Location: Raleigh NC

Job Overview:

The Clinical Trial Associate, in collaboration with global internal and external study team members, supports all phases of the study under departmental and/or study team supervision. Duties may include administrative functions such as minute taking, data entry, tracking, scanning/copying, binder creation, and supply distribution. Includes participation in study meetings, essential document review and Trial Master File (TMF) processing. May include budget negotiation, fee tracking, and amendment processing. Supports multiple studies based on scope. Meets defined chargeability expectations for position.

Job Duties and Responsibilities:

• Participates in internal and external meetings, provides updates as required, may take minutes or assist in action/decision log maintenance
• Supports regulatory inspections and/or audits as required
• Interfaces with vendors as required
• Procures, maintains, and ships study documents, supplies, and materials in compliance with Caidya Standard Operating Procedures (SOPs) and study-specific processes
• Maintains study servers and portals where applicable
• Tracks documents and study status in applicable tracking systems
• Reports document collection and tracking issues to functional lead and/or study team on a regular basis
• Identifies, manages, escalates where appropriate, and resolves site issues effectively
• Assists with ad hoc issue resolution as directed and delegated
• Communicates functional area study status and provides associated reports to the study team as appropriate
• Submits documents and/or files directly within TMF, may conduct document review and/or support with document query resolution
• Performs regular support of site level document collection via Clinical Research Associate (CRA) and/or directly from site as requested
• Assists ongoing completeness review of assigned content within TMF
• Conducts designated final site level TMF review and provisions partial final document collection expectations by CRA at Close Out Visit
• Supports study team with functionality and use of TMF in accordance with study-specific TMF Plan, Caidya SOPs and study-specific processes
• Reviews and maintains study Outlook folders as applicable, provides correspondence to sites, sponsors, and study team members as needed
• Performs other study-specific duties as assigned by Project Manager as agreed by departmental management and in accordance with scope
• Conducts other duties as assigned by departmental management (e.g. Team Leader, Manager, Director)
• Conducts fee tracking and/or data entry
• Assists with amendment tasks including site notification, supply shipment, budget update, Institutional Review Board/Ethics Committee submission, and Informed Consent Form review
• Supports safety letter distribution to sites and IRB as required
  
  

Supervisory Responsibilities: None

Job Requirements:

Education

• College/University graduate preferred, healthcare or life science degree a plus
• Equivalent combination of education and relevant work experience considered
  
  

Experience

• Prior relevant work experience preferred
  
  

Skills/Competencies

• Strong English language written and verbal communication skills
• Strong interpersonal skills
• Team-oriented and a strong team player
• Strong computer skills, including Microsoft Office
• Interest in learning medical terminology
• Exceptional attention to detail
• Highly organized
• Able to work in a dynamic, changing environment
• Demonstrates honesty, trust, fairness, cooperation, self- control, and flexibility
  
  

Capabilities

Minor lifting,

Must work from regional-office location