Clinical Trials Project Manager
Há 6 dias
We are seeking a highly motivated and experienced Clinical Trials Project Manager to join our team at Fortrea. The successful candidate will be responsible for site monitoring, site management, and ensuring the integrity of clinical trials.
Responsibilities:- 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, liaison with vendors, and other duties as assigned.
- Responsible for all aspects of site management as prescribed in project plans.
- Ensure study staff receive proper materials and instructions to safely enter patients into studies.
- Ensure protection of study patients by verifying informed consent procedures and protocol requirements.
- Monitor data for missing or implausible data.
- Ensure resources of Sponsor and Fortrea are spent wisely through efficient monitoring tasks according to SOPs and established guidelines.
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution.
- Thorough knowledge of regulatory requirements, thorough understanding of drug development process, fluency in English, both written and verbal.
- Senior CRAs with at least 3 years of experience, medical device experience preferred, especially cardiovascular but open to any device experience.
- Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow-up of SAEs.
$120,000 - $150,000 per annum, depending on qualifications and experience.
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