[Remote] Clinical Research Associate
Note: The job is a remote job and is open to candidates in USA. Senseonics is a medical technology company dedicated to transforming diabetes management through long-term, implantable continuous glucose monitoring systems. The Clinical Research Associate will be responsible for the overall clinical study conduct of clinical trials to ensure compliance with protocol(s) and Federal regulations, ICH and GCPs, and local requirements.
Responsibilities
- Responsible for planning and implementing activities required to manage clinical trials and ensures adherence to Good Clinical Practices (GCP), ICH guidelines, FDA regulations, MDR requirements, SOPs, and protocols; take ownership for data completion and accuracy
- Contribute to clinical site interactions, including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and supply requests, issue resolution, etc
- Conduct frequent site visits as required throughout the duration of the study, international and domestic
- Train clinic sites on proper product use and operation, including hands on training on sensor insertion and removal
- Perform and manage all on-site and remote monitoring visits as well as support subject study visits to ensure site protocol compliance
- Act as the primary liaison between the sponsor and investigators for multiple sites and studies
- Coach and mentor junior CRAs (CRA I/II) and Clinical Trial Assistants (CTAs), assisting in their training and development
- Maintain Trial Master Files (TMF) and ensure audit readiness of assigned sites
- Assist with study feasibility, site selection, and vendor management, including tracking enrollment rates and study budgets
- Effectively manage external team/vendors activities including CRO,central lab,IRB and other external contractors
- Support commercialization efforts by assisting in the development of clinical training and education materials related to the use of the product
Skills
- Must have a minimum 4-year undergraduate degree in Natural Sciences or Engineering
- Must have a minimum of 1-3 years of applied experience in Clinical Sciences
- Strong analytical, communication, and organizational skills, along with proficiency in Microsoft Office and CTMS/EDC systems
- Strong writing skills, experience with clinical trial report writing
- Must be able to travel extensively, 50-60 % (domestic and international), many times on short notice
- Well-versed in clinical aspects of GCP, FDA, AIMDD, ISO 14155 and other relevant experiences
- Preferred is a graduate degree in same disciplines
- Preferred experience in implantable medical device industry
Company Overview
Company H1B Sponsorship