The Center for Molecular Fingerprinting (CMF, www.cmf.hu ) is developing cutting-edge femtosecond laser technologies to advance electric-field molecular fingerprinting techniques based on field-resolved infrared spectroscopy. The laser spectrometers developed at CMF will be utilized in large scale clinical studies to target disease detection (www.lasers4life.de and www.h4h.hu). To this end, human samples along with clinical information have been collected to perform high-throughput measurements that will encompass several tens of thousands of sample measurements per year within the CMF laboratories.
Our flagship study, H4H (Health for Hungary - Hungary for Health), includes 15,000 participants with planned follow-up periods of 5-10 years. As a Clinical Research Associate you will take on the management of interventional human research project(s) in an expanding team, which already has 18 members.
The research is led by Prof. Dr. Ferenc Krausz, who received the Nobel Prize in 2023. Our research was performed in close collaboration with the Attoworld laboratories (www.attoworld.de/fris) at the Ludwig Maximillians Universität München (LMU) and the Max-Planck Institute of Quantum Optics (MPQ). The aim of the CMF operations is to apply next-generation laser spectrometers for the analysis of human blood samples to non-invasively detect disease and monitor health.
CMF's scientific mission (youtube.com)
Major Tasks Include:
- Full ownership of study management
- Site visiting – coordinating and overseeing the execution of studies and clinical trial;
- Investigators & sites – responsibility for the successful management of all site-related activities from feasibility through maintenance till close-out including Investigator relationship management, document management, site stock monitoring, sample shipment, issue detection, reporting, resolution;
- Compliance – ensuring SOP and regulatory compliance for site activities as well as data integrity and validity, assistance during audit/inspection;
- Regulatory and ethics – submission package compilation, deficiency response, amendment submission;
- Contract and payment – contract negotiation, payment preparation;
- Vendors – involvement in specification, procurement, and commissioning of supplies.
Required Attributes:
- Experience in investigator site management – either in clinical pharmacology trials, or preferably interventional human research trials (i.e. trials w/o investigational drug administration) including feasibility, site initiation, monitoring and close-out, recruitment support, source data verification, query management, plus appropriate document management;
- Regulatory knowledge – familiar with local regulatory requirements;
- Life science background is desirable, but not absolutely necessary (experience in clinical research weighs in more);
- Language knowledge - fluency in Hungarian and English including technical terms;
- IT – strong user-level knowledge of MS Office;
- Interpersonal skills - proactive, enthusiastic team player;
- Flexibility – the ability to tolerate a fast-paced working environment and rapidly changing circumstances.
Strong Advantages:
- Have experience in process and/or SOP development;
- Can demonstrate site management skills.
We offer:
- A versatile range of work packages, including:
- Higher-than-usual cafeteria allowance,
- Private health insurance,
- Yearly performance incentives,
- 30 guaranteed annual vacation days,
- Professional training opportunities.
- Home office option, 1-2 days per week.
- Team activities and team-building events.
- A dynamic work environment with the opportunity to engage in a rapidly evolving and innovative field.
- Long-term opportunities alongside highly qualified and motivated professionals.
- An international work environment with professional development opportunities.
- A solution-oriented atmosphere with the chance to contribute to the success of a dynamic and growing organization.