Job Details

This position will lead study coordination for multiple clinical research studies within the Division of Acute Care Surgery. Coordinator experience and mastery of all job duties from the Clinical Research Coordinator Intermediate position is mandatory.  

Characteristic Duties and Responsibilities:
Contribute to the development of process and tools in all 8 competency domains is expected:

1.    Scientific Concepts and Research Design
2.    Ethical Participant Safety Considerations
3.    Investigational Products Development and Regulation
4.    Clinical Study Operations (GCPs)
5.    Study and Site Management
6.    Data Management and Informatics
7.    Leadership and Professionalism
8.    Communication and Teamwork
 

• Conduct of externally funded, multi-center Critical Care clinical trials, including cutting edge ICU ventilation trials within NHLBI PREVENT-VILI trial, ARDS interventional trials within the BARDA BREATHE ARDS platform and early detection and characterization of necrotizing fasciitis in the NIAID NEFARIOUS trial. Automotive institute trauma CT morphomics studies that would be funded through industry, rather than a federal mechanism.  Regulatory is likely covered under individual site IRBs rather than an SIRB.  Coordination between sites would include: intersite communication and regulatory assurance, data verification audit, management of limited data sets/image data handling, pooled analysis and reporting, possible sponsor interaction.  
• Development of new institutional multidisciplinary collaborative trials in sepsis
• Engagement and ownership through the clinical trials process, including the initial regulatory phase through execution and closeout
• Contribute as a key member of a multidisciplinary Critical Care collaboration
• Support regulatory efforts and facilitate research projects for faculty and fellows in the Division of Acute Care Surgery.  
• A commitment to excellence in clinical research is essential

Senior Requirements

• CRC Governance Committee review and approval
• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary. 

• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire.  (Please review eligibility criteria from SoCRA or ACRP prior to applying.)

   

• Minimum 5 years of directly related experience in clinical research and clinical trials is necessary. 
• (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.)  

Intermediate Requirements

• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP prior