Job Description

Our client, a world leader in life sciences and diagnostics, is looking for a  Clinical Study Associate   based out of   Tucson, AZ. Duration: Long term contract (Possibility of further extension)

As a Clinical Study Associate (CSA) within the Clinical Services Management team, you will play a crucial role in supporting the Clinical Services Project Management Team. Your primary focus will be on managing and coordinating tasks related to Sponsor's monitoring visits and Pharma Partner audits, ensuring that all activities are efficiently executed and compliant with Roche CDx CAP/CLIA Laboratory quality systems. Your day will involve a range of on-site administrative duties designed to keep monitoring visits and audit requests on Task, on Track, and on Time.

Responsibilities

1. Coordinate schedules for Study/site Qualification and Initiation Visits, Monitoring Visits, Closing Visits, and Audits, ensuring timely and organized planning.
   
2. Maintain and prepare laboratory and study documents for audits, including up-to-date Delegation of Authority (DOA) Logs, device accountability logs, and device registration study binders. Collaborate with Lab Manager and/or representative to ensure timely provision of required documentation.
   
3. Facilitate and/or attend monitoring visits, ensuring all activities are conducted smoothly and in compliance with study requirements.
   
4. Complete and manage supplier questionnaires, coordinating with Subject Matter Experts to ensure timely completion and maintenance of documentation.
   
5. Participate in initiatives to enhance processes and improve efficiency within the clinical services environment.
   
6. Perform other tasks as assigned by Clinical Services Management, demonstrating flexibility and adaptability.
   

Education/Skills

• Bachelor’s degree in life sciences, nursing, Business Administration, or a related field; additional qualifications through experience may be considered.
  
• 2+ years in administrative management, entry-level CRA, CTA, or a background in histo-technology laboratories is preferred.
  
• Strong written and verbal communication skills in English; proficiency in other languages is a plus.
  
• Skilled in Microsoft Office (Word, Excel, PowerPoint) and Google Tools.
  
• Excellent organizational abilities with the capability to multitask effectively.
  

Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K

If interested, please send us your updated resume at   hr@dawarconsulting.com

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