Junior Clinical Research Associate at American Friends of Mutala – Harare, Harare

Africa Clinical Research Network (ACRN) is an African-led clinical research organization building the next generation of trial capacity across the continent. We work with existing hospitals, research units, and investigators to enable high-quality clinical research—from investigator-initiated studies to late-phase and registration trials—while strengthening local systems, skills, and infrastructure.

ACRN operates as a pan-African site management and research delivery platform, combining strong clinical operations, regulatory expertise, data and digital systems, and quality management. Our model is practical and embedded: we focus on making trials work in real settings, reducing friction for sites, sponsors, and regulators, and delivering reliable, audit-ready data.

We partner closely with governments, regulators, academic institutions, and industry to expand Africa’s role in global clinical research, while ensuring that studies generate local value—through workforce development, institutional strengthening, and improved patient care.

At ACRN, you’ll work on meaningful, complex projects with global impact, alongside a multidisciplinary team that values rigor, accountability, and innovation. We are building something durable, ambitious, and distinctly African—and we are looking for people who want to help shape it.

About the role

The Clinical Research Associate I (CRA I – IC2) supports site monitoring and site management activities across clinical trials conducted within ACRN’s regulated CRO/SMO environment. Working under the supervision and guidance of a Senior CRA or CRA Manager, the role conducts on-site and remote monitoring activities, supports site start-up and close-out, and ensures trials are executed in compliance with ICH-GCP, applicable regulatory requirements, approved protocols, and ACRN SOPs.

The CRA I focuses on building strong foundational monitoring skills, including source data verification, regulatory document review, and participant safety oversight, while progressively developing independent judgment in risk identification, issue escalation, and site performance management. The role contributes directly to high-quality, compliant trial execution and inspection readiness.

What you'll do

• Conduct on-site and remote monitoring visits under supervision, in accordance with monitoring plans and SOPs.
• Perform source data verification (SDV) and source data review (SDR) for critical study data.
• Review site compliance with study protocols, ICH-GCP, and regulatory requirements.

• Support site start-up activities, including preparation for site initiation visits (SIVs).
• Assist with verification of site readiness, training documentation, and essential documents.
• Support site close-out activities, including reconciliation of study documentation.

• Review data entered into electronic data capture (EDC) systems for accuracy and completeness.
• Raise, document, and follow up on data queries in collaboration with site staff.
• Support timely resolution of queries and escalation of unresolved issues.

• Review site regulatory and essential documents for completeness, accuracy, and version control.
• Ensure essential documents are filed correctly in the eTMF in accordance with SOPs.
• Support ongoing maintenance of inspection-ready site files.

• Review documentation of adverse events (AEs) and serious adverse events (SAEs) at site level.
• Ensure safety events are documented and reported in accordance with protocol and SOPs.
• Escalate safety concerns promptly to senior monitoring or safety staff.

• Maintain accurate monitoring visit records, site status updates, and milestones in the Clinical Trial Management System (CTMS).
• Upload monitoring reports, correspondence, and documents to the eTMF in a timely manner.

• Identify site-level operational, data quality, or compliance issues during monitoring activities.
• Escalate risks, deviations, and concerns to the Senior CRA or CRA Manager.
• Support implementation and follow-up of corrective actions as directed.

• Build professional, collaborative working relationships with investigators and site staff.
• Provide guidance to sites on protocol requirements and documentation expectations under supervision.
• Communicate monitoring findings clearly and professionally.

• Participate in GCP, protocol, and role-specific training.
• Seek feedback and coaching to build independent monitoring competence.
• Contribute to lessons learned and monitoring best practices as experience grows.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Public Health, Pharmacy, or a related field.

• 1–3 years’ experience in clinical research, site coordination, or monitoring roles desired.

• Interest in supporting clinical trials in a regulated environment.
• Familiarity with ICH-GCP, clinical trial documentation, and EDC systems.