Job Detail

Job Overview:

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