Join to apply for the Clinical Research Nurse II role at Thermo Fisher Scientific.
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.).
Work Schedule
Standard (Mon-Fri)
Overview
TrialMed is a premier global clinical site network, offering comprehensive services for clinical trials from early to late phases (Phase I to Phase IV). As a unified brand, TrialMed consolidates all clinical trial offerings under one global name, ensuring a seamless experience for stakeholders.
Role 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, ECGs, 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 and maintains 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.
Qualifications and Skills
* Solid 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.
* Good decision-making, negotiation and influencing skills.
* Good communication skills and English fluency will be an advantage.
* Good organizational skills.
* Good proficiency in basic computer applications.
* Good interpersonal skills to work in a team environment.
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.
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