Syneos Health is hiring an Italian-speaking SSU Regulatory Coordinator (Contract Management Assistant) to join a client-dedicated team. In this role, you will assist in the delivery of Site Start-Up (SSU) activities globally, focusing on investigator site contracts, ethics and regulatory submissions, and essential documents. You will ensure all documentation complies with sponsor and company requirements, supporting the initiation of clinical trial sites.
What You'll Do
- Assist in administering contract management and essential document processes, coordinating with protocol, informed consent, institution, investigator, vendor, and customer agreements.
- Support quality control and translation processes for submissions, contracts, and essential documents.
- Under supervision, assist in negotiations of budgets and contracts with sites and via the Site Contracts Service Center until resolution.
- Assist in reviewing contracts for completeness and accuracy, ensuring corrections are made and documented.
- Generate amended contract or budget documents as needed, prepare contract management documentation, and help streamline internal processes.
- Arrange the execution of Clinical Trial Agreements (CTAs) and archive documents into repositories with proper metadata capture.
- Review and comply with SOPs and Work Instructions in a timely manner, keep training records updated, and ensure timesheet compliance.
- Ensure all relevant documents are submitted to the Trial Master File (TMF) per Company SOP and Sponsor requirements.
What We're Looking For
- Associate’s Degree or an equivalent combination of education and training.
- Strong computer skills, including proficiency in Word, Excel, PowerPoint, and Publisher.
- Business-level proficiency in written and spoken English.
- Ability to interact effectively with investigative site personnel and internal stakeholders.
- Good organizational skills and attention to detail, with proven ability to handle multiple tasks.
- Ability to take direction from multiple individuals and set priorities accordingly.
- Demonstrated ability to work independently and as part of a team.
- Ability to utilize problem-solving techniques effectively.
- Quality-driven approach in all managed activities.
- Flexibility and willingness to adapt to a rapidly changing environment and learn new functions.
Nice to Have
- Proficiency in additional languages is a plus.
Technical Stack
- Microsoft Word, Excel, PowerPoint, Publisher
Team & Environment
You will work with oversight from the SSU Country Manager and Central and Shared Services leadership. The role involves collaboration with internal and external team members.
Syneos Health is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations to assist employees in performing the essential functions of the job.
