Lead Clinical Research Associate
Julius Clinical Research is a unique Academic Research Organization (ARO), providing world class phase II-IV drug research by combining academic excellence with industry benchmark operational performance in clinical trials. Our strength is our flexibility, ability to respond to customer needs and operate globally on one quality framework, while assuring academic excellence.
The Position
To further strengthen the position of Julius Clinical Research, we are currently seeking experienced Lead Clinical Research Associate(s). This person will be responsible for the management of the clinical part of one or more clinical trials in multiple countries, and will report this to the responsible (senior) project manager.
The Lead Clinical Research Associate (Senior CRA) will be responsible for a diversity of specific tasks/ duties, some are listed below:
• Monitors the progress of the clinical activities in the assigned countries against previously defined performance indicators in terms of both quality and quantity and adjusts implementation as necessary
• Reviews monitoring visit reports relating to the clinical trial
• Performs accompanied site visits with the CRAs of the assigned countries
• Ensures CRA adherence to study timelines
• Trains CRAs of the assigned countries with regards to protocol, CRF and study-specific procedures.
• Participates in, and jointly organises meetings for investigators and CRAs.
• Monitors the clinical activities in the assigned countries in accordance with SOPs, statutory and ICH/GCP guidelines, compliance with the protocol, including report compilation and follow-up with the set timelines.
• Ensures the correct query process is followed in collaboration with Data Management.
• Ensures the correct reporting and follow-up of Adverse Events, Serious Adverse Events and SUSARs.
• Supports the study team during inspections by Healthcare Authorities or Audits.
• Ensures the reliable documentation and archiving of study documents, both at the study site and ‘in-house’.
• Ensures that information is conveyed effectively between the Project Manager and the study team.
The Candidate
In order to meet the requirements for this interesting and challenging job opportunity, the right profile for a Lead CRA is a professional with the following capabilities:
• Minimal educational background at Higher Vocational Educational level (HBO).
• Preferably a (Bio) Medical background.
• At least 3 years of experience as CRA in the pharmaceutical or CRO industry preferably with experience in coaching and managing other CRAs.
• Up to date knowledge on regulations and ICH/GCP guidelines.
• Command of English.
• Not a 9-17 person but someone who likes to combine hard work with fun.
• Able to work independently but also within teams.
• Willingness to travel.
• Proactive person with excellent communication skills.
How to apply
Are you interested in joining Julius Clinical Research? Apply by sending us your CV together with your motivation letter to vacancies@juliusclinical.com.
