Clinical Research Associate (CRA)

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Department: Family Medicine and Population Health

Let's shape the future - University of Antwerp

The University of Antwerp is a dynamic, forward-thinking university. We offer an innovative academic education to more than 20,000 students, conduct pioneering scientific research and play an important service-providing role in society. With more than 6000 employees from 100 different countries, we are helping to build tomorrow’s world every day. Together we push back boundaries and set a course for the future – a future that you can help to shape.

The Global Health Institute’s (GHI) is part of the Faculty of Medicine and Health Sciences at University of Antwerp.  Its mission is to conduct research aimed at improving the health of people worldwide, build capacity for global health research and engage in the implementation and evaluation of evidence-based interventions for health problems in low- and middle-income countries. Research activities cover different areas such as reproductive health, chronic disease management, (neglected) infectious diseases and vaccine-preventable diseases.

Emerging and re-emerging infectious diseases such as mpox and Ebola continue to pose major public health threats for many countries and have disproportionately affected the Democratic Republic of Congo (DRC). Vaccines are considered as a key public health intervention in the management of disease outbreaks. Generating evidence through clinical trials that are locally relevant and scientifically rigorous is essential to move developed vaccines to licensure in different populations. To support the monitoring and quality oversight within vaccine trials in the DRC, GHI is looking for an experienced full-time (100%) Clinical Research Associate (CRA)

Position

• Perform on-site and remote monitoring visits (including source data verification, SDV) at clinical trial sites in the DRC, in line with the monitoring plan, GCP and applicable regulations.
• Data review and query management in electronic data capture (EDC) systems.
• Verify that the rights and well-being of trial participants are protected and that reported trial data are accurate, complete and verifiable against source documents.
• Take responsibility for the setup, maintenance and review of the Trial Master File (TMF) and the Investigator Site File (ISF), ensuring they are complete, accurate and inspection-ready throughout the trial life cycle.
• Review the delegation log and other essential documents to confirm that tasks are appropriately delegated and that site staff are adequately qualified and trained.
• Perform sample reconciliation and verify the consistency of laboratory and biological sample data against source records and the study database.
• Verify informed consent processes and documentation for all enrolled participants.
• Evaluate Investigational Product management (accountability, dispensing, return/destruction, storage conditions and cold chain compliance) at site level.
• Identify, document and follow up on protocol deviations, and support sites in implementing corrective and preventive actions (CAPA).
• Verify the reporting of serious adverse events (SAEs) and adverse events of special interest (AESIs) in line with the protocol and safety reporting requirements.
• Write clear and timely monitoring visit reports and follow-up letters and track the resolution of open action items.
• Collaborate and coordinate with CRAs and monitors from other institutions involved in the same trial, to ensure a harmonised and comprehensive approach to monitoring.
• Support site feasibility, initiation, training and close-out activities as required.
• Contribute to the development and review of monitoring plans, SOPs and other study-specific documents.
• Support inspection and audit readiness at site and sponsor level.
• Be willing to make regular field visits to the DRC (and possibly other African countries), including to remote sites, to carry out monitoring and related activities.

Profile

• Master's degree in medicine, Pharmacy, Nursing, Biomedical Sciences, Life Sciences, or a related field, or demonstrated relevant experience in clinical research, medical monitoring, pharmacovigilance, or a related healthcare environment.
• Preferable 2 years of experience as a CRA or clinical monitor.
• Experience with vaccine, infectious disease, or global health trials.
• Training/certification in ICH Good Clinical Practice (GCP).
• Experience with source data verification (SDV) and with maintaining the Trial Master File (TMF) and Investigator Site File (ISF).
• Experience with Clinical Trial Management System, eTMF and EDC systems; Experience with REDcap is an asset.
• Strong issue escalation, CAPA management, and risk assessment skills.
• Knowledge of medical terminology, as well as scientific and clinical research methods.
• High attention to detail and the ability to review data and documents accurately and systematically.
• Ability to apply knowledge and skills effectively in a highly organised manner, adhering to legal guidelines and standard operating procedures.
• Excellent organisational skills and good problem-solving skills.
• Strong interest in scientific work, a flexible attitude and a strong sense of initiative and responsibility.
• Good communication and interpersonal skills, including the ability to work with site staff and partners from different institutions.
• Excellent knowledge of English and good knowledge of French is essential, as monitoring will be carried out in the DRC; knowledge of Dutch is a plus.
• High proficiency with MS Office.
• Ability to work in a team and, if necessary, independently, including alongside CRAs and monitors from other institutions or CROs.
• Ability to work productively with minimal supervision and meet deadlines;
• Willingness to travel under challenging field conditions in the DRC (and other countries).
• Experience working in remote settings in Africa is a great asset.

Reporting

You will report to and be supervised by a lead project manager at the University of Antwerp, who has a direct functional link with the Principal Investigators of the clinical trial.

What we offer

• Working in an intellectually stimulating, international and interdisciplinary research environment, with room for personal initiative.
• A fixed-term contract of 12 months for 1 FTE position with a possibility of extension pending funding.
• Start date: ASAP or September 2026 at the latest.
• You will receive a gross monthly salary within pay band 7.1-9.1 of the pay scales of the Administrative and Technical Staff. Your entry-level grade depends on your relevant professional experience. More information on our pay scales and other benefits can be found here on our website.
• You get meal vouchers, eco vouchers, internet connectivity allowance, group insurance, guaranteed income insurance, and a bicycle allowance or full reimbursement of your commute by public transport.
• You will work largely at Campus Drie Eiken with in a dynamic and stimulating working environment and flexible working time arrangements.
• Find out more about working at the University of Antwerp and discover all the additional benefits we offer.

How to apply

• You can apply for this job through the University of Antwerp’s online job application platform until 3 August 2026, 24h CET. Click on ‘apply for job’, complete the online application form and don’t forget to include a motivation letter and CV.
• The selection committee will review all applications as soon as possible after the application deadline. Once a decision has been made, we will notify you and inform you of the possible next step(s) in the selection procedure.
• If you have any questions about the content of the job or the relevant projects, please contact the project manager, Maha Salloum, maha.salloum@uantwerpen.be, or the head of GHI, Prof. Jean-Pierre Van geertruyden, jean-pierre.vangeertruyden@uantwerpen.be. If you have any questions about the online application form, please check the Frequently Asked Questions or send an email to jobs@uantwerp.be.

The University of Antwerp is a sustainable, family-friendly organisation which invests in its employees’ growth. We aim to foster diversity and attach great importance to equal opportunities, regardless of gender identity (M/F/X), disability, race, ethnicity, religion or belief, sexual orientation or age. We encourage people from diverse backgrounds and with diverse characteristics to apply.