Freelance Clinical Research Associate (CRA) - Austria
AKRN Scientific Consulting
This is a Freelance position (0,1 to 0,5 FTE) for clinical trial projects based in Vienna, Austria. Under the direction of the Director of Clinical Operations, the Sr. CRA will monitor and support the clinical trial. The CRA will perform the job according to intern SOP and external requirements.
- Strong knowledge of local clinical sites and Ethics Committees.
- Database management (data collection, review, and query).
- Maintaining close contact with the local study site coordinators and investigators.
- Leading the clinical team to successfully drive clinical studies under appropriate quality standards, including ICH/GCP, ISO, MDD, MDR, and applicable global regulations, along with company compliance requirements.
- Lead clinical scientific discussions with local regulatory agencies, investigators, and clinical key opinion leaders (KOL).
- Drives setting of team goals and milestones; monitors progress.
- Develop and maintain relationships with investigators, coordinators, and site staff.
- Provide project/study management and monitoring plans for projects.
- Safety analyses and safety assessments (or appoint designee).
- Write and review publications which originate from the clinical activities (or appoint designee).
- Availability to work as a Freelance contractor in Austria for an international CRO.
- This person needs to be Austria based, knowledgeable in Austrian sites.
- Demonstrable experience in clinical trials and monitoring. (Minimum 2 years of experience)
- Advanced knowledge of clinical and outcomes research study design. (Mandatory)
- Experience as a Clinical Research Consultant. (Mandatory)
- Computer proficiency (Microsoft® Office).
- Good communication and organizational / time management skills.
- Self-motivation with the ability to work under pressure to meet deadlines.
- Detail and process-oriented, positive attitude and approach, multi-tasking capability.
- Working knowledge of ICH guidelines / local regulations / ISO14155 regulations, device development, and clinical monitoring procedures.
- Bachelor's degree in life sciences.
- Advanced degree (Masters or PhD) preferred.
- English Speaker. (Mandatory)
- Local Native Speaker. (Mandatory)
Send an email with your CV and cover letter to: [email protected]