Clinical Research Associate I or II - Respiratory

Job Overview:Clinical Research Associate and Clinical Research Associate II - RespiratoryWhy settle for one thing when you can have everything. Covance gives you the best two for one opportunity for career growth. Who doesn’t want twice the perks – working at Covance—one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus.As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise. You will enjoy the best of both worlds—all the benefits that come along with Covance’s Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor using their systems and processes. This also comes with the benefit of bringing your strong therapeutic experience to a single protocol or sponsor portfolio. This allows your expertise to shine through as you also become engrained in the sponsor culture helping to bring more therapies out to patients.Covance’s FSP model is flexible and scalable. Our teams are collaborative and proactive – a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research.Covance’s reach is global – extending to 60+ countries making us one of the largest FSP CROs. So not matter where you are locating on the globe we have an FSP opportunity for you. In this role, the selected candidate will be responsible for all aspects of site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance. Additionally, you will be responsible for all aspects of registry management and general on-site monitoring duties including ensuring that study staff have proper protocol materials and instructions; verification of informed consent procedures and that protocol requirements are adhered to per regulatory guidelines; ensure integrity of data for the CRFs and other data collection tools with careful review; monitor data for missing or implausible data. Also will ensure the resources of the Sponsor and Company are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Company travel policy. Responsible for all aspects of registry management as prescribed in the project plans; undertake feasibility work when requested. Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor.Education/Qualifications:

University or college degree, or certification in a related allied health profession from an appropriately accredited institution

A minimum of 2 years of Clinical Monitoring experience for CRA II level and 6 months for CRA level.

At least 6 months of experience working with Respiratory clinical research trials

In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered.Experience:

Valid Driver’s License

Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries

Thorough understanding of the drug development process

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