other
Posted 2 weeks agoCRA I, Norway
at Fortrea
Oslo, NorwayOn-site
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
- 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.
- Ensure audit readiness at the site level.
- Prepare accurate and timely trip reports.
- Undertake feasibility work when requested.
- Track and follow-up on 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.
- 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.
- Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
Requirements
- Qualifications (Minimum Required): University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
- experience can be substituted as appropriate. Fortrea may consider relevant and equivalent
- experience in lieu of educational requirements.
- Basic knowledge of Regulatory Guidelines.
- Basic understanding of the clinical trial process.
- experience in a related role (e.g., site management, in-house CRA, study coordinator, research nurse, etc.).