Clinical Studies Coordinator

Quality Assurance · Warminster, Pennsylvania
Department Quality Assurance
Employment Type Full-Time
Minimum Experience Mid-level
Compensation $80,000 - $100,000 / yr

LifeLens Technologies, Inc. is a medical device developer located in Warminster, PA. We are pioneering innovative next generation treatment devices for personal health monitoring.

 

You will have the opportunity to work on cutting-edge technologies designed to revolutionize wearable health care. Your passion and drive will be rewarded with a competitive salary, benefits, and long-term growth opportunities.


The ideal candidate is detail oriented and goal driven. You are a capable problem solver who is comfortable researching solutions autonomously. You have excellent organizational skills and superior verbal and written communication skills.

 

This is a full-time, on-site position. Some travel is required.

Essential Functions


  • Design and prepare clinical and analytical medical device performance study plans, protocols, and reports, statistical data analysis plans, and associated study data collection forms.
  • Supervise study sites and activities during studies to ensure adherence to protocols and terms of the study
  • Communicate with study investigators about activities in all phases of the studies including contracts and approvals and compliance and IRBs.
  • You are aware of US 21 CFR 820 and EU 13485 quality system requirements
  • Oversees and resolves operational aspects of clinical trials in partnership with project team and in accordance with standard operating procedures (SOP) and good clinical practice (GCP), Design Controls, Labeling Requirements.
  • Monitors and reports progress of clinical studies
  • Works to resolve issues and follows up with team related to clinical studies
  • Travels as necessary to facilitate and support clinical trials

Competencies


  • Excellent written and verbal communication skills
  • Ability to prioritize and work independently
  • Basic Project Management Methods and knowledge
  • 5+ years' experience running clinical trials required

Education


Bachelor’s degree in Life Science or related field required


Covid19 Note


LifeLens will conduct interviews within the safety guidelines outlined by Governor Wolf and the PA Department of Health. All new hires will be required to show proof of vaccination on their first day of employment. (Religious and medical accommodations will be recognized.)

 

Thank You

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  • Location
    Warminster, Pennsylvania
  • Department
    Quality Assurance
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level
  • Compensation
    $80,000 - $100,000 / yr