Clinical Research Coordinator

Job Description: The CRC II is responsible for managing and conducting clinical trials at a clinical site in a manner which is in accordance to the study protocol, standard operating procedures (SOPs), ICH-GCP, HIPAA, IATA and other regulatory guidelines that apply to clinical research. 

Responsibilities: 

• Proactively manages and leads a clinical site in conducting clinical research.  
• Independently maintain correspondence with the IRB such as safety reporting, annual renewals, and other IRB submissions. 
• Works with investigator to find potential subjects per protocol eligibility. Schedules study visits and information sessions with subjects.  
• Enrolls subjects by properly assessing eligibility criteria, consenting individuals, and obtaining other authorizations in a manner consistent with safety and quality standards as recommended by ICH guidelines, SOPs, and the study protocol.   
• Conducts protocol related study visits and procedures as delegated by investigator such as EKGs, phlebotomy, IP accountability, etc. 
• Maintains and ensures quality source and regulatory documentation throughout the clinical trial.  
• Monitors health and safety of subjects by following up with study participant’s medical providers, obtaining relevant medical records, documenting adverse and serious adverse events, and presenting them to the Investigator or Sponsor where appropriate. 
• Creates and maintains databases of subject information, electronic source documentation, and electronic regulatory binders through the various components of the electronic data management system.  
• Prepares documents for review by sponsors, monitors and regulatory authorities, as necessary. 
• Independently manages correspondence with sponsors, monitors and regulatory authorities, including monitoring visits. 

Skills and Experiences: 

• Undergraduate Degree required 
• At least 1.5 years experience in clinical research required 
• Prior Phlebotomy experience required 
• Proficiency in using computerized systems such as Microsoft applications, CTMS, IWRS, EDC, and other vendor systems used in clinical research. 
• Understanding of ICH-GCP and HIPAA regulations – prior training certifications a plus. 
• Prior experience in managing monitoring visits, study start-up, and close-out activities required 
• Must be a quick learner with the ability to become independent, collaborate with team members, and positively contribute to the culture and value of the team and company!  

Additional Benefits: 

• Advancement Opportunities  
• Travel Reimbursement 
• Free Costco Membership 
• Mandatory Birthday Holidays 
• HSA Account 
• Team Outings 
• Collaborative, Positive Work Environment