Introduction

Chartered in 1983, Aga Khan University (AKU) is a private, autonomous, and self-governing international university, with 13 teaching sites in 6 countries over three continents. An integral part of the Aga Khan Development Network, AKU provides higher education in multiple health science and social science disciplines, carries out research pertinent primarily to low- and middle-income countries and operates 7 hospitals (soon 8) and over 325 outreach clinics, all at international standards. It has almost 2,500 students and 14,000 staff. The University is both a model of academic excellence and an agent of social change. As a leading international institution dedicated to excellence and change, AKU operates on the core principles of quality, relevance, impact, and access.

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.)

Personal Characteristics & Behaviours

• Excellent written and Verbal communication skills
• Ability to work within a multidisciplinary team
• Strong critical thinking and Analytical skills
• Ability to multitask and handle diverse sets of tasks for multiple studies and clinics simultaneously
• Demonstrate proactivity and ability to work with minimum supervision.
• Ability to be flexible and work in a variety of related roles
• Proficient in MS Office
• Empathetic, culturally sensitive with a high level of respect for colleagues, patients and their families

• 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.

• Excellent written and Verbal communication skills
• Ability to work within a multidisciplinary team
• Strong critical thinking and Analytical skills
• Ability to multitask and handle diverse sets of tasks for multiple studies and clinics simultaneously
• Demonstrate proactivity and ability to work with minimum supervision.
• Ability to be flexible and work in a variety of related roles
• Proficient in MS Office
• Empathetic, culturally sensitive with a high level of respect for colleagues, patients and their families
• Good Clinical Practices (GCPSs)
• Clinical trial processes
• Nursing patient care
• Biomaterials handling
• Health safety practices

• 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