The Trial Nurse is responsible for providing nursing support to the SMAART-MAP trial,
ensuring the safe and ethical conduct of the trial in compliance with Good Clinical Practice
(GCP) guidelines, study protocols, and regulatory requirements. The role involves participant
screening, recruitment, data collection, administering study interventions, monitoring patient
safety, and reporting adverse events. The Trial Nurse works closely with the Study site
coordinator, clinical team, and study participants to ensure successful study outcomes.
Key Responsibilities:
1. Participant Screening & Recruitment:
o Assist in the screening and recruitment of study participants by explaining study
procedures, obtaining, and documenting informed consent, and assessing eligibility
based on the study’s inclusion/exclusion criteria.
o Coordinate with the clinical team to schedule and perform pre-screening tests, physical
exams, and lab work as per protocol requirements.
2. Study Interventions & Administration:
o Administer investigational medicinal products (IMPs) or study-related interventions,
including oral medications, or other treatments, in strict adherence to the study protocol.
o Monitor participants during and after the administration of the study drug for any
adverse effects or complications.
3. Patient Monitoring & Safety:
o Monitor and document participants’ vital signs, symptoms, and clinical responses to
study interventions.
o Identify, report, and manage adverse events (AEs) and serious adverse events (SAEs)
in collaboration with the Medical Officer and study team.
o Provide clinical care and support to participants throughout their involvement in the
study, ensuring safety and comfort in line with the protocol
o Accurately collect and record study data in Case Report Forms (CRFs) and ensuring
adherence to protocol timelines.
o Maintain thorough and confidential records of patient information, study procedures,
and interventions.
o Ensure proper source documentation and timely resolution of data queries.
5. Participant Education & Communication:
o Educate study participants on the trial procedures, including study visits, medications,
potential side effects, and follow-up requirements.
o Serve as the primary contact for study participants, addressing concerns or questions
they may have throughout the trial.
o Provide ongoing education about the importance of protocol compliance and report
non-adherence to the study team.
6. Coordination & Collaboration:
o Work closely with clinical trial coordinators, investigators, pharmacists, and laboratory
staff to ensure the smooth execution of the study protocol.
o Collaborate with multidisciplinary teams to ensure that clinical assessments, sample
collections, and procedures are performed according to the study schedule.
o Assist in the preparation for monitoring visits, audits, and inspections by regulatory
bodies.
7. Follow-up Visits:
o Conduct follow-up assessments and visits with study participants, including gathering
vital signs, collecting lab samples, and ensuring ongoing compliance with the study
protocol.
o Track participant progress and adherence to the study schedule, ensuring retention and
appropriate follow-up.
8. Compliance & Regulatory Adherence:
o Ensure that all study activities are conducted in accordance with GCP, institutional
policies, and regulatory requirements.
o Participate in team meetings, training sessions, and updates on protocol amendments or
regulatory changes.
o Support monitoring preparation and assist in the resolution of any regulatory issues.
Qualifications:
o Registered Nurse (Diploma in Nursing Science).
o Must be registered with Uganda Nurses and Midwives Council (UNMC] with a valid
and current nursing license.
Experience:
o Previous experience in clinical research, clinical trials, or a similar healthcare setting
preferred.
Skills:
o Strong organizational and time-management skills.
o Excellent communication and interpersonal abilities.
o Attention to detail and accuracy in data collection and documentation.
o Ability to work independently and collaboratively in a team setting.
o Fluent in languages spoken at the site area (e.g
English/Luganda/Lumasaba/Lugwere/Ateso/kumam
3
Technical Skills:
o Proficient in basic computer applications (e.g., Microsoft Office), scanning and
photocopying.
Preferred Experience:
o Experience in a specific therapeutic area (e.g., Paediatric/or Medical nursing) relevant
to clinical trials.
o Familiarity with investigational product administration and clinical research protocols.
o Certification in clinical research (e.g., Good Clinical Practice and Human Subject
Protection) is a plus