Clinical Research Nurse I

at  Thermo Fisher Scientific

JOB DESCRIPTION

Summarized Purpose: 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.

Job Complexity: Works on problems of limited scope. Follows standard practices and procedures in analysing situations or data from which answers can be readily obtained.
Job Knowledge: Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.
Supervision Received: Normally receives detailed instructions on all work.
Business Relationships: Contacts are primarily with immediate supervisor, and other personnel in the department. Builds stable working relationships internally.
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

Management Role: No management responsibility

Working Conditions and Environment:

• 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.

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.

Percent Billable: 80% - 100%
Travel 25-75% locally between San Diego and Vista site, if needed.

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