Senior Clinical Research Associate, Medical Device

Kelly Science & Clinical is seeking a Sr. CRA for a full-time, contract-to-hire opportunity with a Biotech Company in Roswell, GA. If youre 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. Senior Contract Clinical Research Associate This role is hybrid with an expectation of 20% in-office work in Roswell,GA office . This contract time frame is approximately nine (9) months to one (1) year with the expectation 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: Overseeing clinical research studies, managing local evidence plans and collaborating with external clinical research organizations (CROs) to ensure successful execution of 3ive Lab-sponsored studies Participate in all phases of clinical research planning and execution, including design, planning, start-up, regulatory, data management, auditing, close-out and reporting activities 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 Provide instruction and coaching to junior clinical research associates 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 Senior CRA may be assigned other responsibilities as needed. The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally. Reporting to and working collaboratively with the Associate Director, Clinical Operations. 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. The Senior CRA must have the ability to effectively operate in a small company environment with potential fast future growth. Qualifications: Bachelors degree in life sciences or healthcare fields 5+ years of relevant experience or an advanced degree with a minimum of 3 years relevant experience, including on-site monitoring Prior experience in clinical trials with medical devices Current clinical research certification required The ability to perform travel up to an average of 70%, depending on project needs Extensive experience in clinical research settings, including auditing and support of regulatory activities Proficient with scientific software such clinical trial management systems (CTMS), electronic data capture systems (EDC) and electronic trial master files (eTMF) Proficient with database software such as, Microsoft Access, SharePoint, 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 This role is hybrid with an expectation of 20% in-office work in Roswell,GA office. Time Period: This contract time frame is approximately nine (9) months to one (1) year with the expectation of subsequent full-time employment 9878760