Work Schedule
12 hr shift/nights
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
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.
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, blood draw, 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.
