Syneos Health

Syneos Health

SSU Regulatory Coordinator

USA-NC-Morrisville

Sponsorship not specified$36k-$60kDetected 5 days ago
GCPNegotiationLogisticsProcess ImprovementClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationCollaborationProblem SolvingOrganizational SkillsMicrosoft Office

About the role

  • SSU Regulatory Coordinator Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.
  • Job Responsibilities Study Start-Up (SSU) Regulatory Coordinator / Contract Logistics Coordinator (CLC) - Sponsor Dedicated Remote - U.S. Only Are you looking to start or grow your career in clinical research and study start-up?
  • You will gain exposure to clinical trial agreements, regulatory documentation, quality review processes, and cross-functional collaboration while contributing to studies that help bring innovative therapies to patients.

Responsibilities

  • 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.
  • 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.
  • This role offers an opportunity to build a strong foundation in clinical research, study start-up, regulatory support, and contract administration while working with an experienced Sponsor-Dedicated team.
  • Further, nothing contained herein should be construed to create an employment contract.

Requirements

  • Ability to interact effectively and professionally with investigative site personnel and internal stakeholders.
  • Ability to take direction from multiple individuals and prioritize assignments accordingly.
  • Proficiency in Microsoft Office, including Excel.
  • If you are looking for an opportunity to launch or grow your career in clinical research and make a meaningful impact, we would love to hear from you.
  • Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work.
  • Occasionally, required skills/experiences for jobs are expressed in brief terms.
  • 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.

Nice to have

  • 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.

Compensation

  • $35,600.00 - $60,400.00
  • The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
  • Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

Benefits

  • Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.
  • 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.
  • 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.
  • Associate's degree or equivalent combination of education and training preferred.

Company info

  • The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
  • The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
  • Demonstrated ability to work independently and as part of a team.

Visa & Work Authorization

  • Job Responsibilities Study Start-Up (SSU) Regulatory Coordinator / Contract Logistics Coordinator (CLC) - Sponsor Dedicated Remote - U.S. Only Are you looking to start or grow your career in clinical research and study start-up?
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This listing is sourced directly from Syneos Health's careers page and normalized into a canonical job model.