SSU & Regulatory Coordinator (Contract Management Assistant)

Syneos Health, Inc.; United States; On-site; USD 55,000 - 75,000; Full time

Job summary

Syneos Health, Inc. is looking for an SSU & Regulatory Coordinator (Contract Management Assistant) to assist in delivering Site Start-Up activities. The role involves ensuring compliance with regulatory and site contract documentation and establishing strong working relationships with internal and external teams. This position emphasizes support in investigator site contracts, ethics submissions, and managing essential documents for site initiation. Ideal candidates should demonstrate problem-solving skills and a commitment to customer service.

Responsibilities

• Provide assistance in delivery of Site Start-Up activities for investigator site contracts.
• Ensure regulatory and site contract documentation complies with sponsor and Company requirements.
• Establish strong working relationships with customers and internal project teams.

Job description

SSU & Regulatory Coordinator (Contract Management Assistant)

Updated: Yesterday
Location: Nationwide, United States
Job ID:25108359

Description

SSU & Regulatory Coordinator (Contract Management Assistant)

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.

Job Responsibilities

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.

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.