Medical Monitor / Clinical Trial Physician

The Global Health Institute (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, strengthen 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.

The Centre for Evaluation of Vaccination (CEV) is part of the Faculty of Medicine and Health Sciences at University of Antwerp. CEV has a long-standing tradition in running national and international vaccine safety & immunogenicity trials (HBV, HPV, polio, influenza, Ross River, Dengue, …). In its 25 years history, CEV has participated in more than 330 clinical trials..

CEV works closely with the Global Health Institute (GHI) on vaccine trials against (re-)emerging pathogens in sub-Saharan Africa; the medical monitor role primarily supports these trials. To strengthen the medical oversight of vaccine clinical trials and to reinforce the clinical team at CEV, the University of Antwerp is looking for a

full-time Medical Monitor / Clinical Trial Physician (100%)

We are seeking qualified and motivated Physicians to serve as Medical Monitor for a clinical research study conducted by GHI UAntwerp in the Democratic Republic of the Congo . The Medical Monitor will provide ongoing medical oversight throughout the conduct of the study, ensuring participant safety, supporting investigators, and contributing to the scientific and medical integrity of the trial. You will conduct this role remotely at Vaccinopolis and be part of an experienced physician team.

In addition, you will participate in clinical trials conducted by CEV at Vaccinopolis and be part of an enthusiastic and driven interdisciplinary team of physicians, researchers, nurses, study coordinators and laboratory technicians. Together with this team, you will conduct clinical studies in healthy volunteers at Vaccinopolis. These studies include ambulatory vaccination studies and may include studies with Controlled Human Infection Models (CHIMs), in which healthy volunteers are infected in a controlled manner and stay in quarantine on our ward for a short period.

Position

Medical Monitoring:

• Provide independent medical safety review throughout the clinical trial.
• Perform regular aggregate review of safety data to identify trends, patterns, and potential risks.
• Review and assess adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and other safety-related information.
• Evaluate the clinical significance, severity, expectedness, and potential relationship of safety events to the investigational product or study procedures.
• Support the timely identification, assessment, and escalation of emerging safety signals.
• Participate in safety review meetings and provide medical interpretation of clinical data.
• Support the preparation and review of safety reports for regulatory authorities, ethics committees, and other stakeholders.

Conduct of clinical trials

• Closely following up and writing study protocols
• Being responsible for the medical aspects of the clinical studies
• Explaining studies to interested volunteers
• Assessing the medical eligibility of volunteers for participation in studies
• Performing clinical examinations and collecting samples
• Following up on test results (e.g. laboratory results)
• Following up on the health of study participants and any adverse events
• Monitoring and reviewing clinical trial safety data
• Reviewing adverse events and serious adverse events, including assessment of severity and causality
• Providing medical advice to study teams and supporting safety review meetings and interactions with safety boards (e.g. DSMB)
• Reporting study and safety data to a high standard of quality
• Scientifically reviewing study documents and research results
• Following up on and developing Standard Operating Procedures
• Participating in the on-call service for cold chain and medical follow-up of participants
• Participating in weekend work during the course of a CHIM study

Profile

• You hold a Master's degree in Medicine and are registered with the Order of Physicians
• You have experience in clinical trials
• Experience in (medical) monitoring of clinical trials is highly appreciated
• Experience with tropical diseases and (re-)emerging infectious diseases is highly appreciated
• Knowledge of ICH-GCP guidelines, or willingness to obtain GCP certification, is required
• You enjoy contributing to the organisation and set-up of clinical studies
• You have a good knowledge of common computer programs (Microsoft 365)
• You are fluent in spoken and written Dutch and English; knowledge of French is an asset
• You are disciplined and work meticulously
• You are positive, eager to learn and communicative
• You work in a quality-oriented, honest and collaborative way
• You are keen to keep developing yourself. A particular interest in infectious diseases and related scientific research is an asset
• Your research qualities are in line with the faculty and university research policy

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;
• Your gross monthly salary will be calculated, based on your relevant experience, according to the assistant physician pay scale in the salary scales for Special Academic Staff.
• You get 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 a dynamic and stimulating working environment and flexible working time arrangements.
• More information on working for the University of Antwerp can be found here.

Want to apply?

• You can apply for this job through the University of Antwerp's online job application platform. Click on 'apply for job', complete the online application form and don't forget to include the following documents: motivation letter and your CV.
• The selection committee will review all applications on a weekly base. Once a decision has been made, we will notify you and inform you of the possible next step(s) in the selection procedure. the vacancy will remain open until the position is filled
• If you have any questions about the content of the job, please contact Maha Salloum, maha.salloum@uantwerpen.be or Ilse De Coster, ilse.decoster@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.