[Remote] Clinical Research Associate, Diagnostics/Med Device

Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company with FDA regulations and ICH guidelines, managing reputed company investigational stages of the clinical trial. Responsibilities • reputed company study start up activities which includes the regulatory document collection, review and approval process for IRB submission • Prepare site regulatory binder • Ensure reputed company 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 reputed company • Ensure subject safety and verify diligence in protecting the confidentiality and wellbeing of study subjects • Verify adequacy, completeness, reliability, and reputed company of trial data collected at study sites • Conduct site qualification, site initiation, interim monitoring and reputed company out reputed company • reputed company and maintain site and investigator relationships to ensure reputed company are managed reputed company • Commute reputed company, concise information to the sponsor in a reputed company manner • Participate in the preparation or creation of study reputed company materials Skills • Bachelor's degree in life sciences or a reputed company 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 reputed company with medical devices • The ability to reputed company 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 (reputed company), and electronic trial master files (eTMF) • Proficient with database software such, reputed company reputed company, SharePoint and electronic medical records (EMR) • Ability to work independently and manage multiple reputed company • Detail-oriented; reputed company to reputed company reputed company tasks with a high degree of accuracy • Superior deductive reasoning, problem-solving, and decision-making abilities • Excellent time management; reputed company to prioritize tasks and accomplish set goals reputed company • Strong written and oral communication skills • Clinical research certification preferred • Working understanding of renal and cardiac therapeutic areas and ICU experience is a plus reputed company • reputed company 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/. Apply tot his job Apply To this Job