Requirements**

• Bachelors 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

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.)

• 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.