Job Summary
The Clinical Research Nurse plays a crucial role in the conduct of clinical trials and research studies. Responsibilities encompass a wide range of activities aimed at ensuring the safety, well-being and compliance of research participants, as well as the integrity of the research data.
Responsibilities
Identify and recruit eligible participants for Phase ≥1 clinical trials;
Screen potential participants based on specific inclusion and exclusion criteria;
Explain the details of the Phase ≥1 clinical trial to potential participants;
Obtain informed consent from participants, ensuring they understand the risks, benefits, and procedures involved, in compliance with Good Clinical Practice (GCP) and human subjects protection;
Administer investigational drugs or treatment/other interventions to participants according to the study protocol;
Monitor participants closely for any adverse reactions or side effects during and after drug administration;
Conduct regular assessments of vital signs, such as blood pressure, heart rate, respiratory rate, and temperature;
Document and report any abnormalities or changes in vital signs;
Perform physical assessments and clinical evaluations as specified in the study protocol;
Monitor and document any changes in participants’ health status;
Promptly report any adverse events or serious adverse events to the study investigator and appropriate regulatory authorities;
Collaborate with the principal investigator, study coordinator, and other team members to ensure the smooth conduct of the trial;
Provide regular updates on participant status and study progress;
Ensure strict adherence to the study protocol and regulatory requirements;
Document all study-related activities accurately and in accordance with Good Clinical Practice (GCP) guidelines;
Collect and process blood samples for pharmacokinetic or other analysis, as specified in the study protocol.
Educate participants about the purpose of the Phase ≥1 clinical trial, the investigational product, and potential side effects;
Be trained and prepared to respond to medical emergencies that may arise during the trial;
Maintain detailed and accurate records of all participant interactions, assessments, and procedures;
Ensure compliance with regulatory requirements and assist in preparing for regulatory inspections;
Follow safety guidelines and procedures to protect both participants and staff involved in the study;
Any other assignment that is deemed appropriate for this level.
Requirements
Bachelor’s degree in Nursing OR Diploma in Nursing with at least 5 years’ research experience;
Current licensure with the Nursing Council of Kenya;
Certification in Basic Life Support (BLS);
CITI/ Research training preferred;
Minimum of 3 years’ experience as a nurse in a hospital setting in inpatient and/or outpatient services with demonstrated knowledge and competencies in nursing clinical practices applied to direct patient care;
Sound working knowledge of Good Clinical Practices (GCP), clinical trial processes, nursing patient care, biomaterials handling, and health safety practices;
Prior experience in operating basic medical equipment (e.g., infusion pump, ECG Machine, etc.).
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