Clinical Research Associate
Vor 3 Tagen
Thermo Fisher Scientific is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will play a critical role in ensuring the success of our clinical trials by providing site management and monitoring services.
Key Responsibilities- Perform and coordinate all aspects of clinical monitoring and site management.
- Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
- Act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects' rights, well-being and data reliability.
- Ensure audit readiness.
- Develop collaborative relationships with investigational sites.
As a Clinical Research Associate, you will be responsible for:
- Monitoring investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
- Ensuring data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Assessing investigational product through physical inventory and records review.
- Documenting observations in reports and letters in a timely manner using approved business writing standards.
- Bringing up observed deficiencies and issues to clinical management expeditiously and following all issues through to resolution.
- 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 2+ years as a clinical research monitor).
- Valid driver's license.
- Full Right to work in Germany.
- Fluency in English and German language to at least C1 level.
As a Clinical Research Associate at Thermo Fisher Scientific, you will have the opportunity to work on a wide range of clinical trials, develop your skills and expertise, and contribute to the success of our company.
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