In-house Clinical Research Associate

Kraków

There are multiple factors contributing to the immune system recognizing cancer and properly launching adaptive immune reactions against it. Ardigen research combines the expertise in Artificial Intelligence, Bioinformatics, Cancer Biology, Immunology and Microbiome to deliver technologies that lead to significantly increased response rates to immunotherapies. To achieve this goal, Ardigen is conducting observational studies to collect the best quality data for developing this technology. 

As an In house Clinical Research Associate, you ensure that the observational clinical studies are delivered successfully by meeting budget agreed timelines and quality standards. You will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects. In this role, you will develop and implement studies strategy, and oversee studies performance against these plans. You will also have input into the development of study-related documents such as clinical protocol, ICFs, SOPs and Clinical Study Agreements.This role focuses on performing all activities required for evaluation, initiation, monitoring and closing clinical trial sites including remote or onsite visits.

Duties and responsibilities

 

  • Creating observational trials protocols 
  • Developing, reviewing and tracking study documents, including ICFs, Clinical DataBase (eCRFs) and eCRF Completion Guideline, Clinical Monitoring Plan and others
  • Collecting and reviewing essential regulatory documents needed for the assigned study, preparing EC submissions
  • Identifying and evaluating trial sites and centres. Assessing the adequacy of potential investigators and trial sites. Performing sites feasibility (evaluation of facilities, personnel, patients population, etc.)
  • Liaising with investigators, consultants and internal team members to set up the timelines and to conduct successfully assigned observational trials
  • Ensuring appropriate and timely Clinical DataBase (eCRF) completion 
  • Training investigators and clinical site personnel regarding study protocol and other related documents and procedures
  • Negotiating study budgets with potential investigators and sites in collaboration with the legal department 
  • Managing and accounting study non-clinical supplies and devices provided to the sites
  • Monitoring observational studies in line with protocol, local regulations, SOPs and procedures including GCP and GLPs
  • Conducting site visits when needed
Requirements

 

  • MSc degree in biology, biotechnology or related field
  • Proven experience acting as a Clinical Research Associate or Clinical Trial Coordinator (1-2 years)
  • Experience in laboratory techniques
  • Knowledge of pharmaceutical industry, terminology and practices
  • Excellent communication skills
  • The ability to build effective relationships with trial centre staff and colleagues
  • Valid driver’s license, proficient driving skills and ability to travel 
  • Excellent verbal and written English
You can get extra points for

 

  • Experience in Observational/Non-interventional/Non-commercial study research
  • Knowledge of Good Laboratory Practice (GLP)
  • Knowledge of Next Generation Sequencing (NGS)
We offer

 

  • Independent role within the company that creates breakthrough solutions in the fight against cancer
  • Flexible working hours and ability to work from home
  • Trainings and language classes
  • Wide range of employee benefits

We kindly ask you to add the following clause to your application: „I hereby express my consent to the processing of my personal data by Ardigen S.A. for the purpose of existing recruitment process”. If you want us to keep the submitted documents also for the purposes of future recruitment processes, we kindly ask you to add the following clause to your application: „I hereby express my consent to the processing of my personal data by Ardigen S.A. for the purpose of future recruitment processes for a period of 3 years from the date of submission of this document, in order to analyse them in terms of the recruitment processes carried out in Ardigen.”

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