Description

SSU Regulatory Coordinator

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? 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.

WHO YOU ARE

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 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.

WHAT YOU WILL DO

• 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.

WHY YOU WILL LOVE THIS OPPORTUNITY

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. 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.

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.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a 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, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

$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.

Get to know Syneos Health

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.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Responsible for providing assistance in the delivery of Site Start-Up (SSU) activities in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and essential documents required for site initiation. Support projects within Clinical Operations on a global scale, with oversight from the SSU Country Manager and Central and Shared Services leadership. Ensures regulatory and site contract documentation complies with sponsor and Company requirements. Works with internal and external team members to implement solutions for project and/or individual site contract related problems. Establishes strong working relationships with customers, internal project teams and sites. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company Standard Operating Procedure (SOP)/Sponsor requirements.