Senior Clinical Research Associate's required for a leading CRO to join their expanding team of experienced CRAs. You will be home based in Hungary.
Key responsibilities:
·You will identify, select, initiate and close-out appropriate investigational sites for clinical studies. You will monitor these sites in order to ensure ensuring compliance to the study protocol, Standard Operating Procedures, applicable regulations, and the principles of ICH-GCP.
·The CRA will also be charged with ensuring the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.
·You will ensure the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.
·Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists
·Assist with study protocol design, development and / or review if required
·Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required
·Provide support to the Project Manager / Country Manager with ad-hoc tasks as required
Candidates Criteria:
·Bachelor's degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline
·Significant experience in performing a Clinical Research Associate role
·Clear understanding of the drug development process
·Significant experience in performing a Clinical Research Associate role
·Work experience within either a hospital, medical / research centre environment, Contract Research Organisation or Pharmaceutical company
·Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials
·Ability to contribute to the development of clinical trial related documents and materials
·Ability to independently perform pre-study initiation, interim monitoring and close out visits as required
·Fluency in English and Hungarian languages (both written and spoken)
·Willingness and ability to travel
·Willingness and ability to be home-based after an initial 3-month period working office based in Budapest
Get in touch with Fareen Choudhry for more information: / 01737 236 737
Keywords:
Senior CRA / CRA III / SCRA / LCRA/ Clinical Research Associate / Life Sciences / Oncology / Hungary / Europe / Budapest / Clinical trials / CRO / Clinical Research Organisation
