What are the responsibilities and job description for the Senior Clinical Trial Associate position at Spectrum Staffing Services/HRStaffers Inc.?
SUMMARY
The Senior Clinical Trial Associate (Sr. CTA) supports the planning, execution, and financial management of Phase I – IV clinical studies. Working under the Clinical Trial Manager (CTM) and Clinical Operations leadership, the Sr. CTA provides oversight of activities performed by partner Clinical Research Organizations (CROs) and ensures compliance with regulatory standards and company procedures.
RESPONSIBILITIES
- Assist in clinical study start-up, execution, data collection, and close-out activities.
- Prepare and review study documents, including clinical protocols, consent forms, and training materials.
- Maintain and oversee the electronic Trial Master File (eTMF) for compliance and completeness.
- Support site regulatory documentation, vendor communication, and study monitoring.
- Act as a primary liaison for study sites and monitors, addressing inquiries and escalating issues as needed.
- Assist in planning and attending Investigator Meetings and site training sessions.
- Track and review clinical site invoices for compliance and Sunshine Act reporting.
- Ensure IRB approval processes are completed and maintain regulatory documentation.
- Monitor patient recruitment and study progress, providing key performance metrics.
- Provide training and mentorship to junior CTAs and contribute to department SOP reviews.
- May serve as trial lead for assigned projects under CTM mentorship.
QUALIFICATIONS
