Clinical Research Nurse II (Flexible Day Hours)

Thermo Fisher ScientificPrague, CzechiaonsiteSalary not postedView the original posting at Thermo Fisher Scientific ↗

Work Schedule Other Environmental Conditions 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 Conducts multiple ongoing clinical trials, of varying size and complexity, involving patients or healthy volunteers/subjects. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrolment and retention of study participants. Provides training and guidance to junior team members. Acts as a lead coordinator for certain studies, taking the overall responsibility thereof at the site, liaising with monitors and other stakeholders Flexible day hours working maximum 20 hours per week. Both day and night shifts (or both) are available! Day to day responsibilities: Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines Provides medical care to patients, always ensuring patient safety comes first Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized 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, blood samples, etc.) Records all patient information and results from test as per protocol on the 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 Reviews the overall plan for study conduct for multiple assigned studies and determines how to accomplish Identifies and communicates any obstacles impeding efficient study conduct Accurately collects and documents data. Ensures correct study documents and computer generated forms are used in compliance with protocol. Ensures that timelines are met by working with relevant staff. Monitors safety and well-being of all study participants through direct and indirect interaction with subjects, and communicates problems to relevant stakeholders Performs clinical assessments of participants, monitors laboratory safety reports, and communicates any serious or potentially serious adverse events as per the company procedure Serves as a primary point of sponsor contact for all research activities for studies assigned Ensures all communications are documented and shared with the appropriate team members Acts as a back-up to direct people manager. This includes but is not limited to, overseeing and assigning work to team members, scheduling, and monitoring time. Involved in the interview and hiring process of new team members. Assists in the training of new team members and provides mentoring. Provides input into evaluations performance reviews of team members . Performs other study related duties as qualified by documented training Qualifications: Education and Experience: Czech Language is essential (minimum A2 level) 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 5+ years’). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered

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