Job Overview:

Responsible for study unit activities in the conduct of clinical trials with emphasis on the safety and welfare of study participants.

Summary of Responsibilities:

• Ensure that the dignity, health, safety, and welfare of participants is given the highest priority at all times.
• Be current with appropriate emergency certifications and company emergency policy and procedures.
• Respond to emergency situations based upon nursing standards.
• Utilize skills, knowledge, nursing diagnosis, and clinical judgement in order to provide a high standard of care for participants in clinical trials.
• Utilize nursing assessment skills to observe participant general well-being and potential adverse events. Document adverse events and take appropriate action as needed.
• Obtain Informed Consent and continue the ICF process by educating, explaining and informing participants of study procedures.
• May obtain medical history.
• Administer investigational compounds to participants (inclusive of parenteral) according to the protocol and applicable regulations.
• Perform study-related activities such as cannulation, telemetry, holter’s, vital signs, ECGs, venipuncture.
• Collect and process biological samples according to the protocol and Standard Operating Procedures.
• Record data obtained in a timely, error free manner according to the protocol and Standard Operating Procedures.
• Maintain an understanding of current regulatory requirements.
• Transcribe source data onto the Case Report Form.
• Take responsibility for quality control of study data.
• Assist with the training and mentorship of clinic staff.
• Attend all required meetings, as appropriate.
• Maintain accurate records of all work undertaken.
• Maintain skills to perform all study tasks, as required.
• Maintain constant awareness of participant safety and dignity at all times.
• Handle participant complaints efficiently and effectively in order that their satisfaction is maintained.
• Ensure that client and participant confidentiality is maintained.
• Respond to client and team queries in a timely manner.
• Take ownership of the quality and standard of your own work.
• Apply NMC code and conduct to all aspects of duties (Leeds).
• Record Adverse Events (AEs) as required.
• Be competent in all aspects of dosing as required by study.
• Undertake Shift Lead position as dictated by workload within the clinic.
• Contribute to clinic projects as required.
• Maintain Advanced Life Support (ALS) certification.
• Responsible for taking a leading role in medical programs (such as Hep B and TB) within the clinic.
• Responsible nurse for study as delegated by CRC. Duties to include but are not limited to: Design and complete dose inventories. Update and train nurses in specific dose techniques for study specific requirements. Liaise with Investigator Team with regards any dosing or study safety aspects. Update nurse team on any study safety additional requirements and rescue medications.
• Assist with protocol review.
• Responsible for SOP review and implementation.
• Assist Physician with Integrated Research Application System (IRAS) (Leeds).
• Assist Physician with writing the GP Letter (Leeds).
• Assist Physician with Safety Risk Management Plan (SRMP).
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• Minimum Required: USA Associate degree/BS in nursing with current licensure in applicable state. CPR/AED certified. ACLS Certified.
• Minimum Required: EUROPE Registered Nurse with the NMC. ALS certified.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• Minimum Required: EUROPE 2-3 years clinical research experience. 4-5 years nursing experience.
• Minimum Required: USA / EUROPE 4-5 years relevant clinical research nursing experience.
• Minimum Required: USA / EUROPE Cross-trained in other areas or departments.

Physical Demands/Work Environment:

• Handling of biologically hazardous or radiolabeled material is necessary.
• Must be able to see (distinguish colors) and hear.
• Must have an excellent command of the English language, both oral and written.
• Must be able to use hands to finger, handle, or touch objects, tools, or controls, including a computer keyboard, for up to 6 hours per day.
• Must be able to stand and/or bend for up to 6 hours per day.
• Overtime, rotating shifts and weekend work as required.

Learn more about our EEO & Accommodations request here.