CRA (all levels), Oncology, client-dedicated, home-based in Austria

vor 3 Wochen

Sankt Pölten, Österreich Syneos Health, Inc. Vollzeit
CRA (all levels), Oncology, client-dedicated, home-based in Austria

Updated: January 13, 2025
Location: Austria-Europe - AUT-Home-Based
Job ID:24006578

CRA (all levels), Oncology, client-dedicated, home-based

We are offering an internal permanent contract with Syneos Health, to be dedicated to one big global pharma client. The role is fully home-based with the option to visit the Vienna office if desired. You would work on one study with 5 sites to manage. We are flexible to adjust the level according to the experience of the person.

The Clinical Research Associate 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. Requires guidance and oversight while developing an understanding of the drug development and commercialization process.

JOB 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 Pharmacoepidemiological Practices (GPP) and protocol compliance.
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
  • Assesses site processes and conducts Source Document Review of appropriate site source documents and medical records.
  • Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
  • Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.
  • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
  • 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 project site personnel, ensuring all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
  • 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.

Qualifications

QUALIFICATION REQUIREMENTS

  • Min. Bachelor’s degree in Life Sciences (or equivalent combination of education, training, and experience), but higher degrees (MSc, or PhD) are preferred.
  • Fluency in English and German is mandatory.
  • Previous experience with onsite independent monitoring of Oncology trials, min 1 yr for CRA I level, and more according to further levels.
  • 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.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

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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