Senior Clinical Research Associate II
Há 10 horas
Job Summary
">We are seeking a highly motivated Senior Clinical Research Associate II to join our global clinical trial management team. As a key member of the team, you will be responsible for site monitoring and site management for clinical studies according to Fortrea Standard Operating Procedures and Regulatory Guidelines.
">About the Role
">The Senior Clinical Research Associate II is responsible for ensuring the implementation of project plans as assigned, functioning as leader for projects of limited scope, and assuming line management responsibilities. The role requires strong leadership skills, excellent communication abilities, and a thorough understanding of regulatory requirements and the drug development process.
">Key Responsibilities
">• Conduct routine monitoring and close-out of clinical sites, maintaining study files, conducting pre-study and initiation visits, and liaising with vendors
">• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements
">• Monitor data for missing or implausible data and ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools
">• Manage travel expenses in an economical fashion according to Fortrea travel policy
">• Prepare accurate and timely trip reports and manage small projects under the direction of a Project Manager/Director
">Requirements
">To be successful in this role, you will require:
">• A university or college degree or certification in a related allied health profession from an appropriately accredited institution
">• Thorough knowledge of regulatory requirements and the drug development process
">• Fluency in English, both written and verbal
">• At least 3 years of experience as a Senior CRA with medical device experience, preferably in cardiovascular
">• Advanced site monitoring skills, advanced study site management skills, and advanced registry administration skills
">• Ability to work with minimal supervision, good planning and organization skills, and good computer skills
">Compensation Package
">We offer a competitive salary range of $80,000-$120,000 per annum, depending on experience, plus additional benefits and bonuses.
">About Us
">Fortrea is a leading global contract research organization dedicated to revolutionizing the development process for pharmaceutical, biotechnology, and medical device companies. We are committed to delivering high-quality clinical trials and providing innovative solutions to our clients.
">Contact Information
">Please submit your application through our website: www.fortrea.com/careers
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