Senior Site Contracts Associate - FSP

Parexel • United States-New Jersey-Remote, NJ

12d • Remote

About The Position

Parexel FSP is looking for a Senior Site Contract Associate (“SCA”) in the US. The SCA is responsible for the negotiation, finalization, and execution of all types of site contracts required for site activation, as well as ancillary documents. Post site activation, the SCA handles amendments to original contracts. The role ensures the highest standard of quality and compliance with regulatory requirements, guidelines, and applicable laws, while protecting the best interests of clients and the company and nurturing positive relationships with clinical trial sites.

Requirements

• Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint.
• 5-8 years of experience in site contracting or a combination with a related field within the CRO industry.
• Strong negotiation, diplomacy, and excellent organizational skills with demonstrated experience handling multiple projects.
• Excellent interpersonal, verbal and written communication skills.
• Strong problem-solving skills.
• Ability to successfully work in a “virtual” team environment.
• Strong analytical skills with the ability to create or interpret legal language and budgets.
• Ability to maintain grace under pressure while displaying a high level of professionalism.
• Ability to align internal and external resources to achieve objectives.
• Attention to detail.
• Ability to comprehend and interpret contract language.
• Ability to identify problems independently and execute solutions.
• Ability to quickly comprehend desired end-result, goal or objective and act to accomplish.
• Polished presentation skills.
• Quality-driven in all managed activities.
• Fluent in written and spoken English.
• Ability to mentor and motivate more junior staff.
• Demonstrate an ability to provide quality feedback and guidance to peers.

Nice To Haves

• Command of additional languages is beneficial.

Responsibilities

• Draft, review and negotiate all site agreements including clinical study agreements, service agreements, team member agreements and other related documents.
• Provide context to comments received from sites based on local legal and business framework, common practices, and past negotiation experience.
• Apply and scrutinize site contract and related documents against negotiation and budget parameters.
• Ensure final documents comply with applicable laws, regulations, and guidelines, including ICH – GCP.
• Ensure the best interest of both clients and Parexel are met.
• Serve as a key communication liaison between site contracts staff and internal and external customers.
• Provide functional guidance and keep internal and external teams aware of all contract statuses or pending issues.
• Prepare correspondence as necessary.
• Manage the contract execution process, including obtaining required signatures and ensuring timely execution by all parties.
• Follow record maintenance and archival guidelines.
• Develop and maintain positive relationships with clinical trial sites.
• Develop and maintain a thorough understanding of the clinical trial protocol, budget, and timelines to ensure contract terms align with trial goals.
• Identify potential issues or concerns with contract terms and collaborate to find mutually acceptable solutions.
• Stay up to date with relevant regulatory requirements, guidelines, and applicable laws.
• Identify if all necessary documents (e.g., Power of Attorney, Insurance Certificates, Indemnification Letters, Informed Consent Form) are in place.
• Track and report on the statuses of site contracting activities to Site Contract Lead, other internal stakeholders, and study teams.
• Perform self-checks for completeness and accuracy of contracts, ensuring changes are appropriately made, approved, and documented.
• Work within forecasted country/site contracting timelines, ensure compliance, and track milestone progress in the contract tracking system.
• Identify possible contract or process operational risks and proactively work with the Site Contract Lead to provide solutions.
• Review and comply with Standard Operating Procedures (SOPs) and other relevant guidance, keep training records updated, and ensure timesheet compliance.
• Ensure adequacy and accuracy of archived records.
• Identify and implement process improvements to increase efficiency and quality in the site contracting process.
• Provide guidance and support to study teams and project management on site contracting matters.
• Participate in cross-functional communication to identify process improvements and contribute to site contracting strategies.
• Train and mentor less experienced staff members on departmental SOPs and ensure quality of team’s work products.
• Maintain and update training material for the site contract team.
• Be familiar with financial implications of the project and hours available/consumed per contract, escalating discrepancies.
• Act as country experts by keeping up to date with country trends in site contracting and utilizing knowledge to inform and guide stakeholders.

Benefits

• Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior