Clinical Research Specialist
2 days ago
At Thermo Fisher Scientific, we are driven by a shared passion for enabling our customers to make the world healthier, cleaner and safer. Our innovative solutions and cutting-edge technologies empower researchers, scientists, and healthcare professionals to accelerate research, solve complex scientific challenges, and drive technological innovation.
Job DescriptionThe Clinical Research Specialist will play a pivotal role in ensuring the successful execution of clinical trials by conducting remote or on-site visits to assess protocol and regulatory compliance. This involves handling required documentation, leading procedures, and guidelines from different sponsors and/or monitoring environments. The ideal candidate will possess effective clinical monitoring skills, a proven understanding of medical/therapeutic area knowledge, and excellent communication skills.
Key Responsibilities- Monitors 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.
- Ensures data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities.
- Assesses investigational product through physical inventory and records review, documenting observations in reports and letters in a timely manner.
- Advances observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.
- Bachelor's degree in a life sciences related field or a Registered Nursing certification.
- Previous experience providing knowledge, skills, and abilities comparable to 2+ years as a clinical research monitor.
- In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience may be considered sufficient for an individual to meet the requirements of the role.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Our company culture stands for integrity, intensity, involvement, and innovation, working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
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