MEA Clinical Research Associate I

Remote - West Coast

60 - 80% Travel Required

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

Did you know?

In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.

We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com

Why settle for one thing when you can have everything? Labcorp Drug Development gives you the best two for one opportunity for career growth. Who doesn’t want twice the perks - working at one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus.

Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. Our reach is global - extending to 60+ countries making us one of the largest FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you.

In this role, you will conduct site monitoring of clinical research studies according to our Standard Operating Procedures, ICH Guidelines and GCP; support for project according to Covance Standard Operating Procedures, ICH Guidelines and GCP; and have site management responsibility for clinical studies according to Labcorp Standard Operating Procedures, ICH Guidelines and GCP.

Additional Responsibilities Include:

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance (as per the training status of the CRAI-MEA); liaise with vendors; and other duties, as assigned
  
• Responsible for aspects of registry management as prescribed in the project plans
  
• General On-Site Monitoring Responsibilities:
  
  • Assist Senior CRAs and CRA-2 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)
    
  • Initiate, monitor and close out clinical investigative sites, with or without direct supervision from Senior Clinical Research Associates, Clinical Team Leads, Project Managers or Project Directors, as assigned based on training status and adequate skillset acquisition. On-site Routine Monitoring Visits should be accompanied by an experienced co-monitor (as per training status and agreement from Line Management).
    
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
    
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
    
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
    
  • Monitor data for missing or implausible data
    
  • Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp travel policy
    
• Travel, including air travel, may be required as per essential job functions
  
• Prepare accurate and timely trip reports; perform CRF review, query generation and resolution against established data review guidelines
  
• Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management
  
• Provide coverage for clinical contact telephone lines, as required
  
• Update, track and maintain study-specific trial management tools/systems
  
• Generate and track drug shipments and supplies, as needed
  
• Track and follow-up on serious adverse events as assigned
  
• Implement study-specific communication plan as assigned
  
• Attend investigators’ meetings, project team meetings and teleconferences, as needed
  
• Perform other duties as assigned.

Requirements:

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
  
• Two or more years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)
  
• COVID-19 vaccination is required

Great Benefits at Labcorp :

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including:

• Medical
  
• Dental
  
• Vision
  
• Life, STD/LTD
  
• 401(K)
  
• Employee Stock Purchase Plan (ESPP)
  
• Paid time off (PTO) or Flexible time off (FTO)
  
• Company bonus where applicable
  
  

Pay Range: $92,000.00

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here .

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Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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