Job Abstract

Position: Clinical Research Start-Up Manager – Hybrid

Job description: The Clinical Research Start-Up Manager is an experience clinical trial research professional with research-specific knowledge and skills, who has general responsibility for managing clinical trials for the Research System . The Clinical Trial Start-Up Manager will train 5 to 6 local sites that are new to clinical trials.  The training will work toward providing the sites guidance to be able to conduct their trials independently from start-up through follow-up and close-out.   
******ensures the integrity and quality of clinical trials are maintained and conducted in accordance with federal, state, and local regulations, Institutional Review Board IRB requirements, and WRI policies and procedures. Utilizing the nursing process, the RN Research Coordinator is primarily responsible for coordinating clinical trials in a manner that holds the protection of human subjects as the most important principle.

Role and responsibilities:

• Area of focus: Asthma Clinical Trials
  

• Will require Site Visits across 5-6 Sites in and around the Brooklyn area
  

• Support Principal Investigator at the site
  

• Debrief Principal Investigator
  

• Train Sites:
  

  • Feasibility
    

  • Start-Up
    

  • Patient Recruiting
    

  • EDC
    

  • Follow-Up
    

  • Close-Out
    

  • Query resolution
    

  • IRB Submissions
    

  • AE/SAE reporting
    

JOB QUALIFICATIONS:

• Minimum requirements to be considered qualified to do the job.

  • Required Minimum Education: Bachelor’s Degree
    

  • 5 years of clinical research experience including Start-Up and Site Management
    

  • 25% Travel: Brooklyn, Rockland, and Westchester
    

  • Regulatory background and experience
    

  • Patient Recruiting
    

  • Experience working with IRB
    

  • EDC experience
    

  
  

• Minimum Certification:
  

  • GCP Certification
    

  
  

• Minimum Skills:
  

  • Strong computer skills; good oral and written communication skills; excellent interpersonal and organization skills.
    

  • Possess excellent time management skills