Vacancies for Administrative and Technical Staff
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Department: Vaccine & infectious disease institute
Regime Full-time
Let’s shape the future - University of Antwerp
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The Centre for the Evaluation of Vaccination (CEV) and the Global Health Institute (GHI) of the Faculty of Medicine and Health Sciences at University of Antwerp (UAntwerp) are looking for a full-time (100%) Project Coordinator for vaccine and controlled human challenge trials conducted in Belgium (at Vaccinopolis) or abroad (e.g. Democratic Republic of the Congo (DRC)).
Background
The CEV and the GHI, integral parts of the Faculty of Medicine and Health Sciences at the University of Antwerp (UAntwerp), are renowned for their pioneering research and significant contributions to public health. These esteemed institutions are committed to advancing the understanding and development of vaccines, particularly in the context of global health challenges.
The CEV is located at Vaccinopolis, a state-of-the-art facility dedicated to conducting vaccine trials and controlled human challenge trials (https://www.vaccinopolis.be/en/human-challenge-trial-unit/). Controlled human challenge trials are critical to evaluate the efficacy and safety of vaccines/drugs in a highly controlled environment, providing valuable insights that can expedite the development of new vaccines. This cutting-edge research is pivotal in addressing pressing health threats and emerging infectious diseases. With the launch of the new Human Challenge Trial Unit at Vaccinopolis and our participation in the MusiCC consortium, where CEV is the sponsor and one clinical trial site of a multi-centre (i.e. Belgium, the UK, and Singapore) COVID-19 human challenge trial, we are looking to expand our team.
In parallel, the GHI’s 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 (www.uantwerpen.be/en/rg/global-health-institute).
The GHI team with it’s expertise in research in low- and middle-income countries and the CEV with it’s knowledge on vaccine research teamed up over the past years to conduct a successful phase 2 Ebola vaccine trial in Boende, a remote and rural location of the Democratic Republic of the Congo (DRC). The next vaccine trials for this team are focused on combating (tropical) infectious diseases (e.g. Mpox, etc.), which pose a significant burden on public health in the region, in the DRC and elsewhere in Africa. By conducting these trials in real-world settings, the institute aims to generate robust data that can inform vaccine deployment strategies and improve health outcomes in (vulnerable) populations.
To support these ambitious projects, we are seeking a dedicated and dynamic Project Coordinator to join our team. The successful candidate will play a crucial role in coordinating vaccine and human challenge trials in Belgium and abroad under the supervision of the Project Manager and the institutes’ and departments’ heads. This position offers a unique opportunity to contribute to groundbreaking research that has the potential to save lives and improve global health. If you are passionate about public health, have strong organizational skills, and are eager to work on innovative projects, we invite you to apply for this exciting opportunity.
Position
As project coordinator of vaccine and human challenge trials in Belgium and abroad you would typically be involved in:
- Study Design and Planning:
- Involvement in the design of the overall study protocol, including objectives, methodology, and participant criteria.
- Coordinating with scientific and medical experts to ensure the study design is robust and ethical.
- Planning timelines and milestones for various phases of the trial.
- Regulatory Compliance:
- Ensuring compliance with all relevant regulations and guidelines, including Good Clinical Practice (GCP) and local regulatory requirements.
- Preparing and submitting necessary documentation to regulatory authorities and ethics committees.
- Participant Recruitment and Management:
- Developing strategies for recruiting and retaining study participants.
- Managing participant data and ensuring confidentiality and ethical handling of personal information.
- Operational Management:
- Coordinating logistics for trial sites.
- Ensuring proper storage and handling of vaccines and other study materials.
- Overseeing the collection, storage, and transport of biological samples.
- Investigational Product (IP) Management:
- Develop and maintain or keep oversight of IP inventory.
- Keep oversight of manufacturing, packaging, and labelling timelines of IP.
- Manage or keep oversight of IP distribution and logistics.
- Monitor or keep oversight of IP usage and accountability.
- Ensure regulatory compliance and staff training.
- Data Management and Analysis:
- Coordinating with data managers, statisticians, data analysts and doctoral students to ensure proper data management and analysis of trial data.
- Monitoring data quality and addressing any issues that arise during the trial.
- Risk Management and Safety Monitoring:
- Developing and implementing risk management plans to address potential challenges and adverse events.
- Monitoring participant safety and managing adverse event reporting.
- Ensuring that a Data Safety Monitoring Board (DSMB) or equivalent is in place and functioning for every study.
- Communication and Reporting:
- Serving as the point of contact between the study team, stakeholders, and regulatory bodies.
- Preparing and presenting progress reports to stakeholders and regulatory agencies.
- Budget and Resource Management:
- Developing and managing the trial budget, ensuring efficient use of resources.
- Securing funding and managing financial aspects of the trial.
- Coordinating with vendors and suppliers for necessary materials and services.
- Quality Assurance and Control:
- Implementing quality control measures to ensure the trial is conducted according to protocol.
- Conducting audits and inspections to ensure compliance and data integrity.
- Addressing any deviations from the protocol and implementing/requesting corrective actions.
- Training and Team Management:
- Training study personnel to ensure they understand their roles and responsibilities.
- Facilitating effective teamwork and communication among the study team.
- Ensuring ongoing education and training for team members on best practices and regulatory changes.
Depending on the study, some of the above mentioned tasks can be outsourced to a Clinical Research Organisation (CRO), in which case you would be in charge of oversight, coordination and ensuring that deliverables are met timely by the CRO.
Profile
- Educational background: You have a Master’s degree in (Bio)Medical or Health sciences (e.g. biomedical sciences, medicine, vaccinology, (clinical) epidemiology, pharmacology, or other relevant discipline).
- Relevant experience:
- Preferably 2-5 years experience in clinical research, project coordination, or a related field.
- Hands-on experience with clinical trials, preferably in vaccines, infectious diseases, or similar areas.
- Experience with regulatory submissions and compliance is an advantage.
- Skills and competences:
- Strong organizational and time management skills, capable of handling multiple tasks and deadlines.
- Excellent communication skills, both written and verbal, for effective interaction with team members, stakeholders, and regulatory bodies.
- You have advanced knowledge of English, (very) good knowledge of French and Dutch;
- Attention to detail to ensure accuracy in documentation and adherence to protocols.
- Basic understanding of clinical trial processes, including participant recruitment, data management, and regulatory requirements.
- Technical Proficiency:
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) for documentation and reporting purposes.
- Basic knowledge of statistical software or data analysis tools can be a plus.
- Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is a plus.
- Interpersonal Skills:
- Ability to work collaboratively in a team environment.
- Problem-solving skills to address challenges that arise during trials.
- Adaptability and flexibility to handle changing priorities and demands.
- Personal Attributes:
- Strong ethical standards and commitment to maintaining participant safety and data integrity.
- Eagerness to learn and develop professionally within the field.
- Proactive attitude and willingness to take on new responsibilities and challenges.
- Willing to travel
What we offer
- Working in an intellectually stimulating, international and interdisciplinary research environment, with room for personal initiative;
- You will work closely with and under the supervision of the senior project manager on the different projects;
- A fixed-term contract of 12 months for 1 FTE position, with perspective of extension for at least another 2 years;
- Start date: November 1st 2024 at the latest;
- You will receive a gross monthly salary within pay band 6.1-8.1 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 primarily work at the University of Antwerp, alternating between the GHI and CEV offices, in a dynamic and stimulating environment. The role also includes occasional travel, approximately 3-5 times per year, with short-term stays of about 1-2 weeks in the DR Congo or other relevant locations;
- Flexible working hours;
- Find out more about working at the University of Antwerp here.
Want to apply
- You can apply for this job through the University of Antwerp’s online job application platform until August 29th, 2024, 24h CET. Click on 'apply for job', complete the online application form and don’t forget to include the following document: motivation letter and your CV.
- The selection committee will review all of the applications as soon as possible after the application deadline. As soon as a decision has been made, we will inform you about the next step(s) in the selection procedure.
- If you have any questions about the content of the job, please contact Dr. Ynke Larivière, ynke.lariviere@uantwerpen.be. (Project Manager GHI and CEV), Prof. Pierre Van Damme, pierre.vandamme@uantwerpen.be (head of CEV) or Prof. Jean-Pierre Van geertruyden, jean-pierre.vangeertruyden@uantwerpen.be (head of GHI). 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 encourage diversity and attach great importance to an inclusive working environment and equal opportunities, regardless of gender identity, disability, race, ethnicity, religion or belief, sexual orientation or age. We encourage people from diverse backgrounds and with diverse characteristics to apply.