Clinical Data Coordinator

To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - email your updated resume at Email - [email protected]. Thank you! 

Pay rate: $35 - $40/hr. (Negotiable)

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)

12 months




Description:

• Oversee the production of Laboratory Systems Operations (LSO) deliverables for assigned clinical trials.
  
• Oversee all LSO timelines for assigned clinical trials and cross-functional meetings for assigned clinical trials.
  
• Coordinate discrepancy resolution efforts needed for complex issues that arise with the sample receiving team.
  
• Represent LSO team in vendor meetings to ensure timely response to projects and/or identified issues.
  
• Act as primary liaison with Regulated Bioanalysis, Biomarker Groups and Central Labs to ensure that priority project deliverables are met.
  

• Plans and manages LSO timelines for assigned clinical trials, specifically the completion of the Lab Specifications and Kit Delivery.
  
• Participates in vendor meetings to ensure proper representation for LSO and timely resolution of outstanding issues.
  
• Manages all process flows and data exchanges with any vendors or internal data providers/consumers.
  
• Assists with the development and review of trial-specific SOW, Laboratory manuals, Data mapping documents based on parameters supplied with MSA with applicable vendors and clinical protocol.
  
• Participates in cross-functional meetings where LSO tasks are discussed.
  
• Continually seeks to improve existing processes.
  
• Develops productive collaborations and communication with other cross functional groups.
  
• Ensures compliance with current SOPs. Participates in any internal quality assurance audits.
  
• Manages sample storage volumes and the sample lifecycle management process.
  

• Bachelor’s degree in life sciences or equivalent field of study is required.
  
• Knowledgeable in clinical trials the end-to-end GLP, clinical study and sample lifecycle.
  
• 1-3 years of clinical study involvement and/or sample processing experience in a GLP regulated environment preferred
  
• Laboratory automation experience is a plus.