Department
Clinical Research Unit
Entity
Aga Khan University
Location
Nairobi, Kenya
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.
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
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.)
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
