CLINICAL STUDIES COORDINATOR
This is a full-time, on-site position. Some travel is required.
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.
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
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
Bachelor’s degree in Life Science or related field required
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.)