Clinical Contracts Analyst

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee the negotiation, execution, and modification of clinical study contracts.

• Act as the main point of contact both internally and externally for contracts and payment matters.

• Ensure adherence to agreements and provide recommendations or negotiate amendments and renewals as needed.

• Facilitate the internal legal review process for contract language.

• Maintain records of contract negotiation correspondence and agreements.

• Monitor changes in regulations and legal frameworks that impact clinical study contracts and reimbursement practices.

• Address contractual and payment issues by escalating them and suggesting potential solutions.

• Oversee the clinical compensation process, including database management, reporting, and payments to investigators and IRBs.

• Manage contractual and financial data within clinical trial databases.

• Provide support in data management, analytics, reporting, and business intelligence.

• Track project timelines to ensure compliance with contract and compensation obligations.

• Create study compensation agreement templates and secure necessary approvals.

• Ensure alignment among protocols, contract templates, informed consent documentation, and compensation agreements.

• Collaborate on the development and testing of study payment programming.

• Liaise with Finance and Accounts Payable regarding payment inquiries.

• Communicate the status of contract and compensation negotiations and executions.

• Develop or negotiate contracts for investigator-initiated research, data use agreements, vendor clinical research contracts, and consulting agreements.

• Identify and implement process enhancements in collaboration with cross-functional teams.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree in a relevant field or equivalent experience.

• Background in clinical research along with knowledge of related regulatory requirements.

• At least five years of experience in contract negotiation/administration and financial tracking/analysis associated with contracts.

• Preferred experience with clinical contracts in pharmaceutical, medical device, healthcare sectors, or Contract Research Organizations.

• Familiarity with MSAs, SOWs, DUAs, NDAs, and contract amendments.

• Understanding of regulatory standards such as CFR and GCP.

• Moderate knowledge of clinical research, medical terminology, healthcare compliance, HIPAA, and the Sunshine Act.

• Proficiency in Microsoft Office Suite, including Word, PowerPoint, Access, Excel, and SharePoint.

• Experience with electronic data capture systems.

• Basic knowledge of relational databases, query design, file manipulation, and table structure.

• Capability to work collaboratively in a team setting and represent the organization on various projects.

• Exceptional written and verbal communication skills, along with strong interpersonal relationship abilities.

• Demonstrated problem-solving, organizational, analytical, and critical thinking capabilities.

• Ability to work autonomously, prioritize tasks, and function effectively within a matrix team environment.

• Willingness to travel approximately 20% of the time, both domestically and internationally.

🏝️ Benefits

• Medical insurance

• Prescription drug insurance

• Dental insurance

• Vision insurance

• Flexible spending accounts

• 401(k) savings plan

• Paid time off (PTO)

• Short-term disability

• Long-term disability

• Parental leave