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Clinical research nurse ii

Cardiff
Thermofisher Scientific
Clinical research nurse
Posted: 24 August
Offer description

Working days, Monday to Friday, 37 hours a week. The main priority will always be patient safety. The Clinical Research Nurse conducts multiple ongoing clinical trials involving patients or healthy volunteers/subjects. They complete all required paperwork to capture data as specified by study protocols and ensure subject safety, understanding, and cooperation during the study process. The nurse interacts with the research site team and other interdepartmental staff and engages in the entire site operations process, including recruitment, enrollment, and retention of study participants.

The responsibilities include:

1. Conducting clinical studies according to FDA/GCP and ICH regulations and guidelines.
2. Providing medical care to patients, always prioritizing patient safety.
3. Scheduling subject visits within protocol windows to maximize scheduling capacity.
4. Performing all study activities such as informed consent, screening, and protocol procedures (vital signs, pregnancy tests, height, weight, ECGs, etc.).
5. Recording all patient information and test results on required forms as per protocol.
6. Completing IP accountability logs and related information where required.
7. Reporting suspected non-compliance to relevant site staff.
8. Ensuring IRB approval is obtained before study initiation and requirements are met throughout.
9. Promoting the company and building positive relationships with patients to ensure retention.
10. Attending site initiation and other relevant meetings for protocol training.
11. Calling patients, scheduling bookings, and following up to confirm appointments or provide information/results.
12. Logging and ensuring the accuracy of information on sponsor systems within designated timeframes.
13. Maintaining source documents, updating patient files, and recording relevant information.
14. Adhering to company COP/SCOP guidelines.
15. Disposing of waste according to standards and assisting in maintaining a neat facility environment.

Qualifications include a solid understanding of the clinical research process (GCP, SOPs, informed consent, safety monitoring), the ability to work independently, analyze and prioritize complex information, and exercise discretion and sound judgment. Good decision-making, negotiation, communication skills, and English fluency are advantageous. Organizational skills, proficiency in basic computer applications, and interpersonal skills are also required.

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our team in our mission to enable our customers to make the world healthier, cleaner, and safer. We support our teams with resources to achieve individual career goals while advancing science through research, development, and delivery of life-changing therapies.

Our work includes clinical research through our PPD portfolio and Accelerated Enrollment Solutions, which optimizes patient journey steps in clinical trials. Your dedication to patient-centered decisions will help improve health outcomes worldwide. Join us to be part of a team of over 100,000 colleagues sharing values of Integrity, Intensity, Innovation, and Involvement, working together to accelerate research, solve scientific challenges, and support patients. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences and perspectives are valued.

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