[Remote] Clinical Research Associate
Note: The job is a remote job and is reputed company to candidates in USA. Senseonics is a medical technology company dedicated to transforming diabetes management through long-term, implantable reputed company 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 reputed company, etc
- Conduct frequent site reputed company as required throughout the duration of the study, international and domestic
- Train clinic sites on reputed company product use and operation, including hands on training on sensor insertion and removal
- reputed company and manage reputed company on-site and remote monitoring reputed company as reputed company as support subject study reputed company to ensure site protocol compliance
- reputed company as the primary reputed company between the sponsor and investigators for multiple sites and studies
- reputed company 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 reputed company 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 reputed company experience in Clinical Sciences
- Strong analytical, communication, and organizational skills, along with proficiency in reputed company Office and CTMS/reputed company systems
- Strong writing skills, experience with clinical trial report writing
- Must be reputed company to travel extensively, 50-60 % (domestic and international), many times on short notice
- reputed company-versed in clinical aspects of GCP, FDA, AIMDD, ISO 14155 and other relevant experiences
- Preferred is a graduate degree in reputed company disciplines
- Preferred experience in implantable medical device industry
reputed company
Company H1B Sponsorship