CRA monitoring clinical trial data and ensuring patient safety in clinical research. Collaborating with staff and maintaining high quality in trial management for Novo Nordisk.
About the role
- Clinical Research Associate at Fortrea monitoring global clinical trials. Collaborating with stakeholders to ensure patient safety and data integrity while adhering to regulatory guidelines.
Responsibilities
- 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
- Responsible for all aspects of site management as prescribed in the project plans
- 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
- 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
- Participate in and follow-up on Quality Control Visits (QC) when requested
- Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Requirements
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
- An equivalent amount of experience can be substituted as appropriate.
- Demonstrated experience of at least 18 months in onsite monitoring global clinical trials from SIV to Close-out
- Understanding of local regulatory guidelines
- Happy to travel interstate to attend site monitoring visits
Benefits
- Monitoring cutting edge global clinical trials
- Have experienced & supportive managers to help grow CRA knowledge and skills
- Career development pathways
- Opportunities to work for dedicated sponsors (FSP) and full service (FSO)
- Access to AI assisted technology to ease their workload
Job title
Job type
Experience level
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Not specified
Degree requirement
Location requirements
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