Clinical Research Associate

Description

The research Center for Molecular Fingerprinting (CMF) develops in collaboration with Ludwig-Maximilians-Universität München (LMU, https://www.lmu.de/en/), and the Max-Planck-Institute of Quantum Optics (MPQ, https://www.mpq.mpg.de/en) cutting-edge femtosecond laser technologies with novel molecular fingerprinting techniques to advance a new type of mid-infrared spectroscopy on the electric-field level. The consortium of a highly interdisciplinary team of laser physicists, data scientists, molecular biologists and clinical personnel is focusing on demonstrating how newly developed infrared spectroscopy can be utilized for probing molecularly complex human biofluids for the development of a new in vitro diagnostic assay (https://www.lasers4life.de/). 

If you:

• feel to have more potential than treadmilling the same path from study to study,
• fed up with managing 6 studies with less than 100 subjects involved
• would like to make a difference & be part of a project of historical importance with unprecedented magnitude,
• can exhibit creative & strategic thinking,
• have more interest in science and the future vs. dividends for the shareholders, 
• or you are just about to start your clinical research career and looking for an opportunity with a quick development path, 

then apply for our open position in Budapest, Szeged or Debrecen!

Our institution is setting up a unique longitudinal human research study with the participation of more than 15,000 individuals across Hungary to bring to the international forefront a groundbreaking diagnostic procedure that could be a game changer in the field of health monitoring. As a Clinical Research Associate, Project Coordinator you will take on the management of interventional human research project(s) in an expanding team, which already has 10 members. 

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 and 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

Apart from those fulfilling the below, we also open positions with a quick development path for enthusiastic new entrants (starting as Clinical Research Assistant) - contact us for more details. 

• 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.

A strong plus, if you

• hold a medical doctor degree; 
• hold a Ph.D.; 
• have experience in process and/or SOP development; 
• can demonstrate site management skills. 

What we can offer

• A broad range of activities in a dynamically evolving second-to-none endeavor and professional environment. 
• Long-term opportunity with highly qualified and motivated professionals. 
• A versatile range of work packages (cafeteria, professional training, guaranteed 30 days of annual vacation days for the whole year). 
• Occasional home office. 
• Work in an international environment and the opportunity for professional development. 
• Solution-oriented atmosphere and the opportunity to participate in the success of a dynamic and growing organization. 
• The location of the position is Budapest/Szeged/Debrecen, Hungary.