Cra/scra Switzerland

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Now we are looking for CRA/SCRA to join us in Switzerland

You would have the following main responsibilities:

- Site administration and site monitoring responsibility for clinical studies according to Fortrea Standard Operating Procedures, ICH Guidelines and GCP
- Site management responsibility for clinical studies according to Fortrea Standard Operating Procedures, ICH Guidelines and GCP
- Act in the project role of as Local Project Coordinator or Lead CRA as assigned
- Assures the implementation of project plans as assigned

Essential Job Duties- 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 Fortrea 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 Fortrea travel policy- Travel, including air travel, may be required and is an essential function of the job.- 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 Fortrea 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 Fortrea 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 management

Experience- 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.- Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs- Good planning, organization and problem solving abilities- Ability to work with mínimal supervision- Good communication and interpersonal skills- Good analytical and negotiation skills I Computer competency- Fluent in local office language and in English, both written and verbal- Works efficiently and effectively in a matrix environment

+ One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred

Education/Qualifications/Certifications and Licenses- 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.- Thorough knowledge of monitoring procedures- Basic understanding of the clinical trial process- Valid Driver’s License

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the sw