Senior Clinical Study Assistant

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.

We are seeking a Senior Clinical Study Assistant who will independently perform tasks related to planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. This will include providing day-to- day clinical activities including regulatory inspection readiness, collaborating with Clin Ops/Study Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities. Will perform department al tasks as needed .

Responsibilities :

• Review and/or approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
  
• Supporting/oversight of risk-based monitoring.
  
• Attendance of key team meetings as required; may make presentations (e.g., data, etc.).
  
• Supporting regulatory inspection readiness (e.g., preparation of materials and/or participation during regulatory inspections.)
  
  

• Support clinical trial systems (e.g., CTMS/TMF/COMPASS associated activities for selected studies
  
• Supporting vendor contract administration as required.
  
• Support study close-out activities, e.g., financial reconciliation
  
• Supporting additional ad-hoc activities as needed, as agreed with Manager(s).
  
• Provide support for departmental tasks, including but not limited to:
  
  

• Maintaining knowledge of systems and processes.
  
• Attending internal and external training as needed and maintaining up-to-date training record.
  
  

Requirements:

Education :

• Bachelor’s degree or equivalent international degree required.
  
  

Experience :

• 2-4 years’ experience in pharmaceutical industry, clinical research organization, or related role .
  
• Experience in Phase 2 and 3 studies and global/international studies is advantageous.
  
• Experience working across multiple therapeutic areas (including oncology) is advantageous.
  
  

Skills

• Knowledge in global/regional regulatory and compliance requirements for clinical research.
  
• Demonstrated excellence in task management and cross-functional collaboration.
  
• Excellent communication skills.
  
• Excellent teamwork, organizational, interpersonal, and problem-solving skills.
  
  

• Fluent business English (oral and written).
  
  

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
  
  

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.

For more information about how we collect and store your personal data, please see our Privacy Statement .