Biotech and Pharmaceutical, Case Report Form (CRF), Clinical Assessment, Clinical Laboratory, Clinical Nursing, Clinical Research, Clinical Trial, Communication Skills, Cross-Functional, Detail Oriented, Electrical Components, Electrocardiogram, Electronic Data Capture (EDC), English Language, Establish Priorities, FDA (Food and Drug Administration), GCP (Good Clinical Practices), GMP (Good Manufacturing Practices), Healthcare, ICH Regulations, IP (Internet Protocol), IRB/IEC (Institutional Review Board/Independent Ethics Committee), Information Technology & Information Systems, Informed Consent, Licensed Practical Nurse/Licensed Vocational Nurse, Medical Records, Medical Tests, Negotiation Skills, Nursing Credentials, Office Equipment, Organizational Skills, Patient Care, Patient Safety, Problem Solving Skills, Research Nursing, Research Skills, Safety Standards, Site Initiation, Standard Operating Procedures (SOP), Team Player, Time Management
Work Schedule
Other
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Join Us as a Clinical Research Nurse - Make an Impact at the Forefront of Innovation
The Clinical Research Nurse conducts at least one ongoing clinical trial that may involve patients or healthy volunteers. Interacts with the research site team and interdepartmental staff to ensure positive interactions with patients at site for study planning, from initiation to closeout.
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
What You'll Do:
- Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines.
- Provide medical care to patients, always ensuring patient safety comes first.
- Perform all defined study activities (i.e., informed consent, screening, and protocol procedures which include but are not limited to vital signs, pregnancy tests, height, weight, ECGs, etc.).
- Record all patient information and results from tests as per protocol on required forms.
- Complete IP accountability logs and associated information when required.
- Report suspected non-compliance to relevant site staff.
- Ensure that IRB approval is obtained prior to study initiation and that IRB requirements are met throughout the study.
- Promote the company and build a positive relationship with patients to ensure retention.
- Attend site initiation meetings and all other relevant meetings to receive training on the protocol.
- Call patients, handle patient bookings, and perform follow-up calls when required to confirm bookings or provide information or results.
- Log and complete information on sponsor systems, ensuring accuracy (i.e., case report forms, EDC, etc.) and timely completion.
- Gather source documents, update patient files and notes, always ensuring relevant and up-to-date information is recorded.
- Adhere to company COP/SCOP.
- Dispose of waste according to standards and assist in maintaining a neat appearance of the facility when required.
Education and Experience Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field.
- Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with local health care authority.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years').
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities:
- Basic understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety
monitoring, etc.)
- Capable of working independently, analyzing and working with attention to detail, processing and
prioritizing sensitive complex information and problem solving
- Demonstrated ability to exercise discretion and sound judgement
- Possess decision-making, negotiation and influencing skills
- Good communication skills and English fluency will be an advantage
- Great organizational skills
- Essential proficiency in basic computer applications
- Great interpersonal skills to work in a team environment
Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Work is performed in an office/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Occasional travel, may be domestic or international.
Why join us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthroughs.
T
Thermo Fisher Scientific Inc
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.
All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.
If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.
Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.
10,000 employees or more
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