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Stefanini Group is hiring for a Clinical Research Associate Exciting opportunity awaits! Let us help you get started. Call Aditya Yadav - (248-728-6487/ Aditya.Yadav@stefanini.com
SUMMARY: The Clinical Research Associate is primarily responsible for carrying out the responsibilities involved in the execution of clinical trials. This includes site initiation, monitoring and close out of clinical trial sites. Clinical trials may be carried out at various phases in the life cycle of the product. Responsibilities: Monitor activities conducted by clinical investigative sites as they relate to sponsor clinical studies to ensure successful execution of the protocol. Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Protocol/Amendment(s), Monitoring Plans, and to quality standards in conducting clinical research. Ensure subject safety and verify diligence in protecting the confidentiality and well-being of study subjects Conduct site qualification, site initiation, interim monitoring and close out visits for Phase 1-4 studies Verify completeness, accuracy, consistency, and compliance/quality of trial data collected at study sites; identify deficiencies and discrepancies and provides remedial training and/or corrective action as required; generate and resolve queries in between monitoring visits Complete monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended action to secure compliance Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job. Qualifications: BA or BS with scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent. Minimum of 4 years of clinical research monitoring experience. 4+ years of clinical research monitoring experience. Experience in on-site or remote monitoring of investigational drug or device trials is required. Industry certification - SOCRA or ACRP, or equivalent preferred. Knowledge and skills: This role may be office and/or home-based. Infrequent visits to a Company office may be requested Ability to travel preferred but flexible, maximum 25% Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable federal regulations. Experience in monitoring sites, ability to prioritize and multi-task in a fast-paced environment Detailed oriented, with strong time management and organizational skills Excellent communication and team skills Effective interpersonal skills Working knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials. Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc. Demonstrated business ethics and integrity.