Clinical Research Nurse I

TN Germany; Leipzig; Vor Ort; EUR 40.000 - 70.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Clinical Research Nurse I to join their collaborative team in Leipzig. This role involves conducting clinical trials, ensuring patient safety, and adhering to regulatory guidelines. You will interact with patients and the research site team, contributing to meaningful health outcomes. This position offers a chance to be part of a mission-driven organization dedicated to making the world healthier and safer. If you're passionate about clinical research and patient care, this opportunity is perfect for you.

Qualifikationen

• Bachelor's degree or equivalent in the clinical/medical field is essential.
• Must hold a valid nursing license within the country of operation.

Aufgaben

• Conducts clinical studies according to FDA/GCP and ICH regulations.
• Provides medical care to patients, ensuring patient safety.
• Records patient information and results as per protocol.

Kenntnisse

Clinical Research Process

Attention to Detail

Decision-Making Skills

Communication Skills

Organizational Skills

Interpersonal Skills

Ausbildung

Bachelor's Degree in Clinical/Medical Field

Valid Nursing License

Tools

Basic Computer Applications

Jobbeschreibung

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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 – To enable 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.

Alongside clinical research through our PPD clinical research portfolio, our work in Accelerated Enrollment Solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.

We are currently looking to recruit a Clinical Research Nurse I to complement the collaborative team at our Synexus research site in Leipzig, Germany. Working days, Monday to Friday, 32 hours per week. 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.

Key responsibilities for a Clinical Research Nurse I are as follows:

1. Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
2. Provides medical care to patients, always ensuring patient safety comes first.
3. Performs all defined study activities (e.g., informed consent, screening, protocol procedures including vital signs, pregnancy tests, height, weight, ECGs, etc.).
4. Records all patient information and results from tests as per protocol on required forms. Where required, may complete IP accountability logs and associated information.
5. Reports suspected non-compliance to relevant site staff.
6. Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
7. Promotes the company and builds a positive relationship with patients to ensure retention.
8. Attends site initiation meetings and all other relevant meetings to receive training on protocol.
9. May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
10. Logs and completes information on sponsor systems, ensuring all information provided is accurate (e.g., case report forms, EDC) and completed within the timeframe. Gathers source documents, updates patient files and notes, always ensuring relevant and most up-to-date information is recorded.
11. Adheres to company COP/SCOP.
12. May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.

Knowledge, Skills and Abilities:

1. Basic understanding of the clinical research process (GCP, SOPs, informed consent, safety monitoring, etc.).
2. Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving.
3. Demonstrated ability to exercise discretion and sound judgement.
4. Adequate decision-making, negotiation and influencing skills.
5. Decent communication skills; fluency in German is an advantage.
6. Decent organizational skills.
7. Essential proficiency in basic computer applications.
8. Decent interpersonal skills to work in a team environment.

Qualifications:

1. Education and Experience: Bachelor's degree or equivalent and relevant formal academic/vocational qualification in the clinical/medical field.
2. Must hold a valid nursing license (RN, LVN, LPN) within the country of operation. Must be registered with the local healthcare authority.
3. Previous experience that provides the knowledge, skills, and abilities to perform the job (0 to 2 years’ experience preferred).

In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for the role.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. 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. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.