Clinical Research Nurse I - Birmingham, AL

at  Thermo Fisher Scientific

JOB DESCRIPTION

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

QUALIFICATIONS:

Education and Experience:

• 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 AND 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
• Adequate decision-making, negotiation and influencing skills
• Decent communication skills and English fluency will be an advantage
• Decent organizational skills
• Essential proficiency in basic computer applications
• Decent interpersonal skills to work in a team environment

PHYSICAL REQUIREMENTS:

• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.

requirements are met throughout the study.

• Promotes the company and builds a positive relationship with patients to ensure retention.
• Attends site initiation meetings and all other relevant meetings to receiv

SUMMARIZED PURPOSE:

The Clinical Research Nurse I plays a vital role in supporting clinical trials by coordinating and managing patient care related to research studies. This position involves working closely with the research team to ensure compliance with study protocols and regulatory requirements while providing high-quality care to participants.
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.

ESSENTIAL FUNCTIONS

• Conducts clinical studies according to FDA/GCP and ICH regulations and

guidelines.

• Provides medical care to patients, always ensuring patient safety comes first.
• Performs all defined study activities (i.e, informed consent, screening, and

protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG’s, etc.).

• Records all patient information and results from tests as per protocol on

required forms.

• Where required, may complete IP accountability logs and associated information.
• Reports suspected non-compliance to relevant site staff.
• Ensures that IRB approval is obtained prior to study initiation and IRB

requirements are met throughout the study.

• Promotes the company and builds a positive relationship with patients to ensure retention.
• Attends site initiation meetings and all other relevant meetings to receive

training on protocol.

• May be required to call patients, do patient bookings and follow-up calls to

confirm bookings or provide information or results.

• Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
• Gathers source documents, updates patient files and notes, always ensuring

relevant and most up to date information is recorded.

• Adheres to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in

keeping a general neat appearance of the facility.