Clinical Research Associate Diagnostics (IVD)

Kelly Science & Clinical is seeking a CRA for a full-time, contract-to-hire opportunity with a Biotech Company in Atlanta, GA. If you are passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts. Contract Clinical Research Associate This role is remote with high travel. Must be near a major airport, in the Central or Pacific time zone. This contract time frame is approximately nine (9) months to one (1) year with the possibility of subsequent full-time employment. Overview: Our client is a well-funded startup medical device company early in its development that is seeking an experienced, ambitious, enthusiastic clinical research associate (CRA) to join our growing team. The role of the CRA is to ensure clinical studies are conducted in compliance with FDA regulations and ICH guidelines. The CRA will be involved in all investigational stages of the clinical trial, including identifying site(s); and setting up, initiating, monitoring and closing the trial upon completion or termination. The CRA is encouraged to have and strong organizational skills, interpersonal and team participation skills. 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 The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally. Experience: Strong organizational skills, interpersonal and team participation skills are essential. Working understanding of renal and cardiac therapeutic areas and ICU experience is a plus. Apply tot his job Apply To this Job