Clinical Research Associate II - Remote

Company: The Emmes Company, LLC
Location: Rockville
Posted on: January 24, 2023

Job Description:

Clinical Research Associate II
US Remote Worker
The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.
Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.
If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee - from entry level through top executive - to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose
The Clinical Research Associate (CRA) II is responsible for monitoring clinical study sites either onsite at investigative sites or remotely to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. The CRA will conduct monitoring visits and activities in accordance with Emmes SOPs, applicable regulations, and ICH GCP. Up to 80% travel to research sites or between corporate locations is required. Please note that positions that require travel for Emmes must be able to provide proof of being fully vaccinated.

Responsibilities

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• Under supervision of the project CRA staff oversight lead (i.e. Clinical Study Manager, Lead CRA, Project Manager, etc.), independently schedules and conducts remote and on-site monitoring visits such as qualification/pre-study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for-cause visits.
  
• As part of the site visits, independently conducts Informed Consent (ICF) review, source data verification/source document review, review for compliance with required reporting/tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy/Investigational Product (IP)/Investigational Device (ID) storage location tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead.
  
• Documents observations and monitoring activities in a site visit report at the conclusion of the visit.
  
• Facilitates and oversees Action Item resolution post visit.
  
• Helps to ensure that clinical sites are conducting the study in compliance with protocol/clinical investigational plan, SOPs, ICH GCP, and other applicable regulations.
  
• Provides training and retraining to site staff including protocol, GCP/GDP, and other training under direction from the project CRA staff oversight lead.
  
• Identifies areas requiring follow-up and improvement at each clinical study site and reports findings to project CRA staff oversight lead.
  
• Ensures all visits are conducted according to country regulations, ICH GCP, and company standard operating procedures
  
• Serves as point of contact for study site personnel to answer questions
  
• May assist with the development and/or review of study-related materials including protocols, informed consent forms, monitoring plan, monitoring documents, etc.
  
• Prepares for and attends project team meetings and provides updates on project status and site-specific performance
  
• Works collaboratively and effectively in a project team environment including internal and external colleagues to meet project objectives and timelines
  
• Participates in Investigator Meetings or other client meetings as needed
  
• Assists with filing and archiving of study documents
  
• Assists in preparing sites for audits and may provide support and cooperation during audits/inspections (including translation to Auditor if needed)
  
• May assist with coordination of clinical study supplies
  
• May assist with submission of applications/notifications to Institutional Review Board (IRB)/Ethics Committee (EC)/Regulatory Authority
  
• May assist with site recruitment oversight activities such as developing focused patient recruitment strategies and action plans.
  
• Performs site management activities as required
  
• Other duties as assigned
  
  
  Experience
  
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  • Bachelor's degree (scientific discipline preferred) or equivalent work experience
    
  • At least 1-2 years of relevant monitoring experience (on-site and remote)
    
  • Ability to travel up to 80%
    
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    • Positions that require travel for Emmes must be able to provide proof of being fully vaccinated
      
      
      
    • Proficient with MS Office Suite
      
    • Excellent computer and organizational skills
      
    • High level of attention to detail required
      
    • Ability to work on varying projects and exercise critical thinking
      
    • Self-starter who can work remotely and a team player who can work cross functionally with some oversight
      
    • Knowledgeable in clinical research operations, including interpretation and implementation of country regulations/ICH guidelines, as required per their role as a CRA
      
    • Excellent organizational, interpersonal, and communication skills (both oral and written)
      
    • Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment
      
    • Knowledgeable in prioritization, problem-solving, organization, critical thinking, decisionmaking, time management, and planning activities
      
    • Ability to collaborate with internal and external colleagues and work well in a team-oriented setting
      
      
      Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.
      Why work at Emmes?
      At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
      
      
      
      
      
      
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      • Unlimited Approved Leave
        
        
        
        
        
        
        
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        • Tuition Reimbursement
          
          
          
          
          
          
          
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          • 401k & Profit Sharing Plan
            
            
            
            
            
            
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            • Work From Home Anywhere in the US
              
              
              
              
              
              
              
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              • Maternal/Paternal Leave
                
                
                
                
                
                
                
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                • Casual Dress Code & Work Environment
                  
                  
                  
                  
                  
                  
                  
                  CONNECT WITH US!
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                  Find us on LinkedIn - The Emmes Company, LLC
                  
                  The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

Keywords: The Emmes Company, LLC, Rockville , Clinical Research Associate II - Remote, Healthcare , Rockville, Maryland