Clinical Research Nurse II

Thermo Fisher Scientific • Atlanta, GA

3d

About The Position

The Clinical Research Nurse II conducts multiple ongoing clinical trials involving patients or healthy volunteers/subjects. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, and retention of study participants. 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.

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 2+ years’)
• Solid 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
• Posses decision-making, negotiation and influencing skills
• Good communication skills and English fluency will be an advantage
• Great organizational skills
• Good proficiency in basic computer applications
• Excellent interpersonal skills to work in a team environment

Responsibilities

• Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provide medical care to patients, always ensuring patient safety comes first.
• Schedule subject visits within protocol windows, ensuring scheduling capacity is maximized.
• 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 completing it within the required timeframe.
• Gather and maintain 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level