Sr CRA/CRA II - Home-Based - Single Sponsor, Austria
- Experience Level
- Experienced (non-manager)
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.
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).
- 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