Clinical Research Associate
4 weken geleden
We are seeking a highly skilled Clinical Research Associate (CRA) - Level II to join our team at Thermo Fisher Scientific. As a CRA, you will play a critical role in ensuring the success of our clinical trials by monitoring and managing site activities, ensuring compliance with regulatory requirements, and maintaining accurate records.
Key Responsibilities- Conduct site visits to assess protocol and regulatory compliance, and manage required documentation.
- Manage procedures and guidelines from different sponsors and/or supervising environments.
- Act as a site process specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
- Develop collaborative relationships with investigational sites.
- Monitor investigator sites with a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site processes failure and corrective/preventive actions.
- Ensure data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities.
- Participate in investigator meetings, identify potential investigators, and initiate clinical trial sites according to relevant procedures.
- Ensure that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations.
- Provide trial status tracking and progress update reports to the Clinical Team Manager as required.
- Bachelor's degree in a life sciences-related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor) or completion of PPD Drug Development Fellowship.
- Valid driver's license where applicable.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
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