Updated: February 11, 2025
Location: Austria-Europe - AUT-Home-Based
Job ID: 25001693
We are currently recruiting for an experienced Clinical Research Associate to join our multi-sponsor team in Austria.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Job responsibilities
* Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
* Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient.
* Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
o Assesses site processes
o Conducts Source Document Review of appropriate site source documents and medical records
o Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary
* May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
* Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).
* 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.
* Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities/communication to ensure project objectives, deliverables and timelines are met.
* May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate.
* Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
* Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
* May provide training or mentorship to more junior level CRAs.
Qualifications
What we’re looking for
* Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
* Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
* Previous monitoring experience
* Must demonstrate good computer skills and be able to embrace new technologies
* Excellent communication, presentation and interpersonal skills
* Fluency in German
* Ability to manage required travel
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status.
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