Sr CRA/CRA II - Home-Based - Single Sponsor, Austria

Here at Syneos Health we are currently recruiting for a  (Senior) Clinical Research Associate in Austria to be home-based. This is an excellent permanent opportunity where one can develop their skill set further and work on exciting clinical studies for one sponsor. 

JOB SUMMARY

The Clinical Research Associate I (CRA I) will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements.  Performs all tasks routinely and independently.  May assume clinical functional leadership tasks as assigned, acting as Lead CRA for a project or assessor of peers for sign-off visit purposes (as approved).

Your main responsibilities:  

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmaco-epidemiology Practice (GPP) and protocol compliance. 
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timelines and completeness.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. 
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. 
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. 
• Participates in global clinical monitoring/project staff meetings/ bid defense meetings  (inclusive of Sponsor representation, as applicable).

  Qualifications:

• Bachelor’s degree or RN in a related field or equivalent combination of education
• Min. 1 year of experience as a Clinical Research Associate 
• 3-4 years of experience in the clinical research area
• Oncology experience required
• RBM will be an asset
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills.
• Basic level of critical thinking skills expected
• Fluency in German and English language