SSU Regulatory Coordinator

SSU Regulatory Coordinator

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know:
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Remote – U.S. Only

Are you looking to start or grow your career in clinical research and study start-up? We are seeking a Study Start-Up (SSU) Regulatory Coordinator / Contract Logistics Coordinator (CLC) to join a high-performing Sponsor-Dedicated team supporting a leading global biopharmaceutical company.

In this role, you will support site start-up activities and assist with contract and regulatory documentation, data management, quality review, and administrative projects. You will work closely with internal teams and external stakeholders to help ensure critical study start-up documents are managed accurately and efficiently, supporting the advancement of innovative therapies.

This is an excellent opportunity for an early-career professional who is detail-oriented, organized, and eager to build experience in clinical research, regulatory support, and contract administration.

Required Qualifications

• Associate's degree or equivalent combination of education and training preferred.
• Experience in data management, administrative support, document management or related experience.
• Demonstrated ability to work independently and as part of a team.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Excellent attention to detail and commitment to quality.
• Strong verbal and written communication skills.
• Ability to interact effectively and professionally with investigative site personnel and internal stakeholders.
• Effective problem-solving skills and sound judgment.
• Ability to take direction from multiple individuals and prioritize assignments accordingly.
• Flexibility and willingness to adapt to changing priorities and learn new responsibilities.
• Proficiency in Microsoft Office, including Excel.

Preferred Qualifications

• Experience in a CRO, clinical site, pharmaceutical, biotechnology, or clinical research environment
• Basic understanding of:
• Phase II-IV clinical trials
• ICH-GCP guidelines
• Clinical development and study start-up processes
• Experience with Docu Sign and/or Google Workspace applications.
• Exposure to Confidentiality Agreements (CDAs), Notices of Transfer (No
  
  Ts), or other clinical research agreements.
• Experience supporting contract negotiation, execution, or tracking activities.

• Review final Clinical Trial…