Clinical Research Associate - Sr CRA / CRA II - Phase I - Dallas

Covance Dallas , TX 75201

Posted 1 week ago

Job OverviewPhase I Specific CRA Role in Dallas, Texas * Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned * Responsible for all aspects of site management as prescribed in the project plans * General On-Site Monitoring Responsibilities * Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study * Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements * Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review * Monitor data for missing or implausible data * Ensure the resources of the Sponsor and Covance 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 Covance travel policy * Travel, including air travel, may be required and is an essential function of the job. * Prepare accurate and timely trip reports * 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 * Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned * Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs * Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management * Assist with training, of new employees, e.g. co-monitoring * Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned * Perform other duties as assigned by managementEducation/Qualifications * External Candidates * University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure),AND* a minimum of 2 years of Clinical Monitoring experience. * In lieu of the above education requirement, external candidates with a minimum of 6 years recent clinical monitoring experience will be considered. * Internal Candidates *
  • Internal candidates with a minimum of 2 years of clinical monitoring experience. * Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries * Thorough understanding of the drug development process * Fluent in local office language and in English, both written and verbalExperience * Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs * Advanced site monitoring skills * Advanced study site management skills * Advanced registry administration skills * Ability to work with minimal supervision * Good planning and organization skills * Good computer skills with good working knowledge of a range of computer packages * Advanced verbal and written communication skills * Ability to train and supervise junior staff * Ability to resolve project-related problems and prioritizes workload for self and team * Ability to work within a project team * Works efficiently and effectively in a matrix environment * Valid Driver's LicensePreferred: * One (1) or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred * Local project coordination and/or project management
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