Clinical Research Nurse, Clinical Research Unit

Job Summary

The Clinical Research Nurse/Coordinator 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 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.
• Involve in the departmental quality initiatives such as multidisciplinary clinics, quality projects and assist in quality variance report (QVR) for the department.

Requirements

• Bachelors degree in Nursing OR Diploma in Nursing with at least 3 5 years' research experience
• Current licensure with the Nursing Council of Kenya
• Certification in Basic Life Support (BLS)
• CITI/ Research training preferred

Relevant Experience

• 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 (GCPSs), 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.)