Site Contracts Specialist II or Sr. Site Contracts Specialist

Overview

This role involves supporting clinical research studies by managing and negotiating site-related contract documents. Responsibilities include negotiating Clinical Trial Agreements (CTAs) and related terms with investigative sites and other study locations, reviewing key legal and commercial provisions, and managing contract amendments.

Responsibilities

• Negotiate, draft, review, and finalize Clinical Trial Agreements (CTAs) and other site-related contracts for clinical research studies.
• Lead contract negotiations with investigative sites, hospitals, academic institutions, site networks, and healthcare systems.
• Review legal and commercial terms, including confidentiality, indemnification, insurance, intellectual property, publication rights, and payment provisions.
• Negotiate site budgets and payment schedules in collaboration with study teams and site representatives.
• Identify contractual risks and propose solutions aligned with company and sponsor requirements.
• Manage contract amendments resulting from protocol changes, study extensions, enrollment adjustments, or budget updates.
• Serve as the primary point of contact for site contract-related communications with sponsors, sites, legal counsel, and internal stakeholders.

Requirements

• BA/BS degree in Science, Clinical Research, Medicine, Biology or equivalent combination of education and experience. Advanced degree preferred.
• Experience (+2 years) negotiating, reviewing, and executing Clinical Trial Agreements (CTAs) and other site-related contracts.
• Experience may be gained through employment with a Contract Research Organization (CRO), pharmaceutical/biotechnology sponsor, academic medical center, hospital system, research institution, or investigative site involved in the management and negotiation of clinical research contracts.
• Strong knowledge of the clinical development process and legal and contracting parameters.
• Strong computer skills in Microsoft Office Suite.
• Customer focused; ability to manage challenging priorities and remain flexible and adaptable in stressful situations.
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
• Good understanding of clinical protocols and associated study specifications.
• Excellent understanding of clinical trial start-up processes.
• Project management experience in a fast-paced environment.
• Good vendor management skills.
• Excellent written/oral communication, presentation, documentation, interpersonal skills, and strong team orientation.
• Strong organizational skills with proven ability to handle multiple projects; excellent communication.
• Quality-driven; strong negotiating and problem-solving skills.
• Ability to mentor, lead, and motivate more junior staff.
• Demonstrated ability to provide quality feedback and guidance to peers; contribute to a training and Quality assurance plan within SSU and update SOPs/WI.
• Experience collaborating with Legal, Clinical Operations, Study Start-Up, Regulatory Affairs, and Finance teams.

Preferred Qualifications

• Experience in a Site Start-Up/Site ID job family, including managing and executing the site identification process in accordance with regulations, SOPs, and project requirements.

Compensation & Benefits

• Salary range: $56,400.00 - $115,100.00
• Benefits may include:
  • Company car or car allowance
  • Medical, Dental, and Vision benefits
  • 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
  • Eligibility for paid sick time may vary depending on where you work due to regulated requirements

Location

Not specified in the provided job description.

Additional Information

• Tasks, duties, and responsibilities listed are not exhaustive, and additional duties may be assigned as needed.
• Equivalent experience, skills, and/or education may be considered.
• Nothing in this description is intended to create an employment contract.
• Reasonable accommodations will be provided where appropriate to assist employees or applicants to perform essential job functions, consistent with applicable law.