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.)