SSU Regulatory Coordinator

Syneos Health • Morrisville, NC

5d • Remote

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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 DocuSign and/or Google Workspace applications.
• Exposure to Confidentiality Agreements (CDAs), Notices of Transfer (NoTs), or other clinical research agreements.
• Experience supporting contract negotiation, execution, or tracking activities.

Responsibilities

• Review final Clinical Trial Agreements (CTAs) and amendments for accuracy, completeness, and proper documentation.
• Support the negotiation and execution of Confidentiality Agreements (CDAs) and Notices of Transfer (NoTs).
• Coordinate contract signature and execution activities, ensuring documents are appropriately tracked, filed, and archived.
• Maintain contract files, templates, databases, and document repositories.
• Update and maintain internal project trackers to support study visibility and reporting.
• Review and quality check documents and deliverables for accuracy and compliance.
• Attend internal and sponsor-facing meetings and provide updates on assigned activities.
• Build productive working relationships with internal teams, sponsors, and investigative sites.
• Support process improvement initiatives, pilot programs, and special projects.
• Assist with data management, document organization, and administrative study start-up activities.
• Ensure compliance with applicable SOPs, work instructions, training requirements, and departmental expectations.
• Identify and communicate issues that may impact project timelines and escalate as appropriate.

Benefits

• company car or car allowance
• Health benefits to include Medical, Dental and Vision
• Company match 401k
• eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• flexible paid time off (PTO) and sick time

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree