Clinical Research Specialist

Company: W.L. Gore & Associates
Location: Flagstaff
Posted on: September 22, 2024

Job Description:

About the Role:

We are looking for a Clinical Research Specialist to join our Clinical Research team. The primary responsibility of a Clinical Research Specialist (CRS) is to manage the records associated with clinical investigations to ensure regulatory compliance through quality review, maintenance, and reconciliation activities. The goal of the CRS commitment is to maintain all study records in a constant state of audit and inspection readiness.

This position will be located at our facility in Flagstaff, Arizona, Phoenix, Arizona, Elkton, Maryland or Newark, Delaware with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.

Responsibilities:

• Coordinate the preparation of materials and regulatory documents to meet study goals and established timelines
• Manage clinical study documentation including preparation for study start-up, study conduct, internal/external audits, and final reconciliation
• Assist in the coordination of payment processing for clinical study sites and vendors
• Maintain Clinical Trial Management systems (CTMS/eTMF)
• Coordinate the preparation of study-specific Project, Site, and Subject files
• Interact with Site staff to send, request, and collect regulatory documents
• Quality Control (QC) regulatory document content for compliance. Be prepared to speak for record quality and maintenance during clinical quality assurance audits and regulatory inspections and support audits and inspections as needed (e.g., document collection and quality control)
• Create, track, and maintain training records for study teams, site personnel, and vendors. Assist with content creation, formatting, editing reports and other clinical documents
• Work with Clinical Study Manager to coordinate study-related meetings and communications
• Participate in process improvement initiatives
  
  Required Qualifications:
  
  • Minimum of 2 years of experience in clinical, sponsored, and / or scientific research, nursing, or working within the medical field
  • Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint)
  • Excellent organizational skills and attention to detail
  • Strong verbal and written communication skills
  • Willingness to work on cross-functional teams
  • Ability to travel up to 5%
    
    Desired Qualifications:
    
    • Bachelor's degree in science / health-related field preferred
    • Experience in clinical / scientific research, nursing, or medical devices / pharmaceutical industry preferred
    • Experience with Clinical Trial Management Systems (CTMS/eTMF)
      
      Hybrid Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's hybrid working policies, from the country in which they are employed.
      
      What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
      
      We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefits
      
      We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
      
      Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
      
      Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
      
      Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
      
      Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact

Keywords: W.L. Gore & Associates, Flagstaff , Clinical Research Specialist, Healthcare , Flagstaff, Arizona