SSU Regulatory Coordinator
About The Position
Syneos Health is a leading life sciences services organization that partners with innovators across the drug development and commercialization continuum. The Clinical Solutions team acts with a drug development mindset, applying expertise to understand customer needs and shape solutions. This role is within a high-performing Sponsor-Dedicated team supporting a leading global biopharmaceutical company. The Study Start-Up (SSU) Regulatory Coordinator / Contract Logistics Coordinator (CLC) will support site start-up activities, assist with contract and regulatory documentation, data management, quality review, and administrative projects. The role involves working closely with internal teams and external stakeholders to 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.
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
- Basic understanding of: ICH-GCP guidelines
- Basic understanding of: 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
