[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/.
Apply Now
Apply Now
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/.
Apply Now
Apply Now