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Clinical Research Nurse I

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Thermo Fisher Scientific

15d ago

  • Job
    Full-time
    Entry & Junior Level
  • Science
    Healthcare
  • Berlin

AI generated summary

  • You need a nursing license, a relevant degree, up to 2 years' experience, GCP knowledge, strong decision-making, communication skills, and basic computer proficiency. German fluency is a plus.
  • You will conduct clinical studies, ensure patient safety, perform study activities, record patient information, manage protocols, and maintain accurate documentation while promoting positive patient relationships.

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’)
  • - 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 German fluency will be an advantage
  • - Decent organizational skills
  • - Essential proficiency in basic computer applications
  • - Decent interpersonal skills to work in a team environment

Responsibilities

  • 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.

FAQs

What is the work schedule for the Clinical Research Nurse I position?

The work schedule is standard, from Monday to Friday, for a total of 32 hours per week.

What certifications are required to apply for this role?

Applicants must hold a valid nursing license (RN, LVN, LPN) within the country of operation and be registered with the local health care authority.

Is prior experience necessary for this position?

Yes, previous experience that provides the knowledge, skills, and abilities to perform the job is preferred, typically comparable to 0 to 2 years.

What are the environmental conditions for this job?

The job environment requires adherence to Good Manufacturing Practices (GMP) safety standards, and some degree of Personal Protective Equipment (PPE) is required, such as safety glasses, gloves, and gowns.

Will I need to interact with patients?

Yes, you will conduct clinical studies involving patients or healthy volunteers and will be required to interact positively with them throughout the study process.

Is fluency in German required for this position?

While decent communication skills are essential, fluency in German will be an advantage.

What are the key responsibilities of a Clinical Research Nurse I?

Key responsibilities include conducting clinical studies according to regulations, providing medical care to patients, performing study activities, recording patient information, and ensuring compliance with study protocols.

How important is teamwork in this role?

Teamwork is essential, as the position involves working closely with the research site team and interdepartmental staff to ensure positive patient interactions.

Are there any specific software or computer skills needed for this position?

Essential proficiency in basic computer applications is required, and familiarity with sponsor systems and electronic data capture (EDC) is beneficial.

What values does Thermo Fisher Scientific uphold in their workplace?

Thermo Fisher Scientific values Integrity, Intensity, Innovation, and Involvement among their team members.

Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.