Clinical Research Associate
vor 4 Wochen
At Thermo Fisher Scientific, we're committed to advancing healthcare through innovative solutions. As a Clinical Research Associate, you'll play a critical role in ensuring the success of our clinical trials. Your expertise in site management and quality assurance will be instrumental in delivering high-quality results and driving business growth.
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.
- Act as a site processes specialist, ensuring trials are conducted in accordance with approved protocols, ICH-GCP guidelines, and applicable regulations.
- Ensure audit readiness and develop collaborative relationships with investigational sites.
- Perform detailed tasks and responsibilities as outlined in the task matrix.
A Day in the Life:
- Monitor investigator sites with a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site processes failures and corrective/preventive actions.
- Ensure data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities.
- Assess investigational product through physical inventory and records review.
- Document observations in reports and letters in a timely manner using approved business writing standards.
- Bring up observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
Requirements:
- Bachelor's degree in a life sciences-related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.
- Previous experience providing 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.
What We Offer:
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
- The chance to work on challenging and rewarding projects.
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