CLINICAL STUDIES COORDINATOR

Posted June 23, 2021

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.

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

To apply, send a pdf of your resume to info@lifelenstech.com. Write Clinical Studies Coordinator in the subject line.