Freelance Clinical Research Associate (CRA) - Italy
AKRN Scientific Consulting
This is a Freelance position (0,2 - 0,8FTE) for a clinical trial project based in Italy. Under the direction of the Director of Clinical Operations, the Sr. CRA will implement and coordinate assigned projects, pre-market trials, and post-market registries. The CRA will perform the job according to intern SOP and external requirements.
- Develop clinical research strategies and clinical trial protocols with the support of external advisors/consultants, as applicable.
- Managing all aspects of submissions to the locals' Ethics Committees; clinical trial contract negotiations; Patient Informed Consent (PIC) development, case report form (CRF) design and implementation.
- 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).
- This person needs to be based in Italy, knowledgeable in Italian sites. (Mandatory)
- This person must have more than 5 years of past experience as a CRA. (Mandatory)
- Demonstrable experience in clinical trials and monitoring. (Mandatory)
- Medical device experience. Proficient knowledge of cardiovascular medical terminology. Advanced knowledge of clinical and outcomes research study design. (Mandatory)
- Experience as a Clinical Research Consultant. (Mandatory)
- Experience with Medical Devices. (Class-III Devices is preferred)
- 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 FDA regulation/ ICH guidelines / local regulations / ISO14155 regulations, device development, and clinical monitoring procedures.
- Bachelor's degree in life sciences.
- Advanced degree (Masters or PhD) preferred.
- Italian Speaker. (Mandatory)
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