Covance is searching for a CRA for our Flexible solutions team to be home based in Switzerland.
This is a unique chance to seize! Join Covance and discover a wide range of career opportunities! 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, with or without guidance; liaise with vendors; and other duties, as assigned Responsible for aspects of registry 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 theguidelines, including managing travel expenses in an economical fashion according to Covance travel policy required monitoring tasks in an efficient manner, according to SOPs and established Travel, including air travel, may be required and is an essential function of the job. Prepare accurate and timely trip reports Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by management Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management Provide coverage for clinical contact telephone lines, as required Update, track and maintain study-specific trial management tools/systems Generate and track drug shipments and supplies, as needed Track and follow-up on serious adverse events as assigned Implement study-specific communication plan as assigned Attend investigators’ meetings, project team meetings and teleconferences, as needed Assist Senior CRA in managing investigator site budgets Perform other duties as assigned by management Education/Qualifications:
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure) Experience:Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP Ability to work within a project team Good planning, organization and problem solving abilities Good communication skills, oral and written Good computer skills Works efficiently and effectively in a matrix environment Fluent in French, German and English, both written and verbal