[Remote] Clinical Research Associate, Diagnostics/Med Device

Note: The job is a remote job and is open to candidates in USA. Kelly Science & Clinical is seeking a Clinical Research Associate for a full-time, contract-to-hire opportunity with a Biotech Company. The CRA will ensure clinical studies comply with FDA regulations and ICH guidelines, managing all investigational stages of the clinical trial. Responsibilities • Perform study start up activities which includes the regulatory document collection, review and approval process for IRB submission • Prepare site regulatory binder • Ensure clinical trials are conducted in compliance with protocol/amendment(s), with ICH GCP, SOPs and with applicable regulatory requirements in the assigned countries and sites • Audit the eTMF to ensure that regulatory documents are complete and accurate and audit ready • Ensure subject safety and verify diligence in protecting the confidentiality and wellbeing of study subjects • Verify adequacy, completeness, reliability, and quality of trial data collected at study sites • Conduct site qualification, site initiation, interim monitoring and close out visits • Develop and maintain site and investigator relationships to ensure clinical trials are managed efficiently • Commute clear, concise information to the sponsor in a timely manner • Participate in the preparation or creation of study related materials Skills • Bachelor's degree in life sciences or a healthcare field • 2+ years of relevant experience or an advanced degree with a minimum of 2 years relevant experience, including on-site monitoring • Prior experience in clinical trials with medical devices • The ability to perform travel up to an average of 80%, depending on project needs • Extensive experience in clinical research settings • Proficient with scientific software, including clinical trial management systems (CTMS), electronic data capture systems (EDC), and electronic trial master files (eTMF) • Proficient with database software such, Microsoft Access, SharePoint and electronic medical records (EMR) • Ability to work independently and manage multiple projects • Detail-oriented; able to perform complex tasks with a high degree of accuracy • Superior deductive reasoning, problem-solving, and decision-making abilities • Excellent time management; able to prioritize tasks and accomplish set goals efficiently • Strong written and oral communication skills • Clinical research certification preferred • Working understanding of renal and cardiac therapeutic areas and ICU experience is a plus Company Overview • Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom. It was founded in 1946, and is headquartered in Troy, Michigan, USA, with a workforce of 5001-10000 employees. Its website is https://set.kellyservices.us/.