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Clinical Research Nurse I

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Thermo Fisher Scientific

16d ago

  • Job
    Full-time
    Entry & Junior Level
  • Research & Development
    Healthcare
  • Berlin

AI generated summary

  • You need a nursing license, a relevant degree, some clinical research knowledge, strong decision-making, communication, and organizational skills, plus basic computer proficiency.
  • You will conduct clinical studies, ensure patient safety, perform study activities, record results, maintain patient files, and adhere to guidelines and protocols while building positive patient relationships.

Requirements

  • - 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
  • - 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’).

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, Monday to Friday, for a total of 32 hours per week.

What qualifications are required for this role?

A Bachelor's degree or equivalent relevant qualification in the clinical/medical field is required, along with a valid nursing license (RN, LVN, LPN) registered with the local healthcare authority.

Is experience required for this job?

Previous experience that provides the necessary knowledge, skills, and abilities to perform the job is required, which can be comparable to 0 to 2 years of experience.

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, maintaining patient records, and ensuring compliance with IRB requirements.

Will I be working with hazardous materials?

Yes, this role involves working with hazardous/toxic materials and requires adherence to safety standards and the use of personal protective equipment (PPE).

Is fluency in German necessary for this position?

While not mandatory, decent communication skills and fluency in German will be an advantage for this role.

Are there any specific environmental conditions that I should be aware of?

Yes, you will need to adhere to Good Manufacturing Practices (GMP) Safety Standards, work in an office environment, and wear some degree of PPE.

What skills are deemed essential for this position?

Essential skills include attention to detail, problem-solving, organizational skills, decision-making, and basic proficiency in computer applications.

Does Thermo Fisher Scientific have a commitment to diversity?

Yes, Thermo Fisher Scientific values diverse experiences, backgrounds, and perspectives and is an EEO/Affirmative Action Employer.

Is training provided for new hires?

Yes, training on the protocol and relevant procedures is provided during site initiation meetings and other training sessions.

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.