Shire Jobs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

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 – 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 :

• 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.

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 German fluency will be an advantage

• Decent organizational skills

• Essential proficiency in basic computer applications

• Decent interpersonal skills to work in a team environment

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.

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.

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.