Are you a research coordinator, who can help our team with the set-up, the run-through and the completion of early clinical studies, e.g. phase I studies or n=1 studies? Not only with direct trial related activities, but also by supporting the team to develop therapy research paths. We offer an exciting position for a research coordinator with experience in conducting clinical trials to support the development of these therapies.

Radboud university medical center (Radboudumc) aims to accelerate the development of therapies for rare diseases by filling the gap between preclinical and clinical sciences. The 'Sectorplan Medical Sciences' provides funding for 13 structural positions to foster research and education in this field. For the support of the clinical development of drugs for rare disease, in addition to basic development and education, a clinical drug development team will be appointed.

As a clinical research coordinator you have experience within this field and know how to effectively start up a clinical trial. You have experience with getting ethical approvement, contacting the valorization team, creating budgets and negotiating, and making other working documents.

You work within a team and are a main contact person for research nurses and other study coordinators in the Radboudumc who are also involved in investigator-initiated, non-industry funded clinical trials in rare diseases or phase I studies. You contribute to the expert learning community on drug development and support the project leader with the coordination of the drug development expertise team. Within this team, you will collaborate with two pharmacists, a project leader and one study design methodologist.

Tasks and responsibilities

• Support setting up, running and completion of early clinical trials in the field of rare diseases. As such, tasks may include:
  
  • Reviews and assess the feasibility of new studies.
  • Prepares study budgets.
  • Organises and chairs study team meetings with (principal) investigators and coordinates follow-up actions.
  • Coordinates activities in the preparation, conduct and closure of studies. Maintains contact with the sponsors of studies and follows up actions as a result of monitor visits.
  • Coordinates preparation of the study file and submission of studies to the ethics committee and other bodies.
  • Makes appointments and coordinates communication with and between principal investigator, supporting departments, any hospitals involved and pharmaceutical industry, if applicable in the form of a contract.
  • Negotiates with the pharmaceutical industry.
• Support the drug development expertise team.
• Organizing meetings with investigators and (internal) experts to discuss study design and drug development plans.
• Supporting the development of an expert network at Radboudumc, together with a Rare Disease community manager.
• Supporting the project lead of the drug development team.

Please upload a motivation letter, your curriculum vitae and the sectorplan application form that applies to your position. This form will guide you through some questions that are relevant for the selection.

We are looking for a clinical research coordinator with good organizational skills. You enjoy keeping an overview in various processes with various parties, such as in formal procedures, which may run over long periods of time. You work accurately and in a structured manner on multiple projects/studies simultaneously. You are also comfortable with a combination of working independently and in a team.

Moreover you have:

• At least hbo educated with a medical or related degree.
• Knowledge of Good Clinical Practice (GCP).
• A BROK certification or the willingness to obtain this certification.
• Preferably knowledge and experience of organizational set-up of complex clinical trials.
• Experience with early clinical trials and n=1 trials is preferable.
• Experience in preparing budgets is preferable.
• Good skills with the MS Office package including Word and Excel.
• Good command of the Dutch and English languages, both verbally and in writing.

To ensure broad commitment at the Radboudumc campus, a specific attitude is required:

• Actively contribute to building a Radboudumc community on (rare) disease therapies and drug repurposing.
• Contribute to educational activities to ensure translation of innovative science into teaching programs (students/professionals/patients).

Fixed-term contract: 1 year with a prospect to a permanent contract.

Working at Radboud university medical center means that you are ahead of the curve and working together on the healthcare of the future. And there is more. Our secondary terms of employment are impressive. These are fully tailored to you thanks to our Employment Conditions Selection Model. At Radboud university medical center, you will be given trust, and you will take the responsibility to handle everything together.

• A gross monthly salary between € 3.379 and € 4.632 (scale 9) based on full-time employment.
• From 1 November 2023 the wages will increase by 4%.
• An annual vacation allowance of 8% and an end-of-year bonus of 8.3%.
• If you work irregular hours, you will receive an allowance.
• As a full-time employee (36 hours per week), you are entitled to approximately 168 vacation hours (over 23 days) per year.
• Radboud university medical center pays 70% of the pension premium. You pay the rest of the premium with your gross salary.
• You get a discount on health insurance as well: you can take advantage of two group health insurance plans. UMC Zorgverzekering and CZ collectief.
• We provide annual courses, both professional and personal.

In addition to our terms of employment, we also offer employees various other attractive facilities, such as childcare and sports facilities. Want to learn more? Take a look at the CAO UMC.

Radboudumc

As part of the team that will implement the goals of the ‘Sectorplan Medische wetenschappen’ you contribute directly to attaining the strategic research goals of Radboudumc. The sectorplan is structural funding of the ministry of education, culture and science (OCW) to enhance research and education in medical and health sciences, including attractive working conditions (permanent contracts, lowering work pressure) and enhancing collaboration and profiling of the university medical centers. The sectorplan focuses on three main themes: Prevention, Data-driven innovation, and using fundamental research to have impact in the clinic.

You will be appointed at the Department of Pharmacy, and are expected to work in a multidisciplinary team with members from, for example, Radboud Technology Center Clinical Studies and Biostatistics. The Department of Pharmacy's research activities focus on the following research areas: pharmacology of antimicrobial agents (antiretrovirals, antifungals, antibiotics, and tuberculosis drugs) and oncology drugs, as well as special populations: Pediatrics and Obstetrics. Furthermore, the department houses a state-of-the-art bioanalytical laboratory, a preclinical laboratory focused on drug transport and toxicity, and the Radboud Applied Pharmacometrics group for research support. We have strong national and international collaborations to unravel translational pharmacological research questions.

Radboudumc
Radboud university medical center is a university medical center for patient care, scientific research, and education in Nijmegen. Radboud university medical center strives to be at the forefront of shaping the healthcare of the future. We do this in a person-centered and innovative way, and in close collaboration with our network. We want to have a significant impact on health and healthcare. We want to improve with each passing day, continuously working towards better healthcare, research, and education. And gaining a better understanding of how diseases arise and how we can prevent, treat, and cure them, day in and day out. This way, every patient always receives the best healthcare, now and in the future. Because that is why we do what we do.

Read more about our strategy and what working at Radboud university medical center means. Our colleagues would be happy to tell you about it. #weareradboudumc