Clinical Research Nurse II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Fluctuating Temps hot/cold Office 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 II Make an Impact at the Forefront of Innovation

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 2700 clinical trials across 100 countries in the last 5 years.

What Youll Do:
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.

Education and Experience Requirements:
Bachelors 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)

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:
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

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. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.