[Hiring] Site Contracts Associate I @Parexel

Role Description

The Site Contract Associate I (“SCA”) is responsible for negotiation with sites, finalization, and execution of all types of site contracts required for site activation. SCA is also responsible for ancillary documents associated to site contracts. Post site activation, SCA is responsible for negotiation, finalization, and execution of any amendments to the original contracts. The SCA ensures the highest standard of quality of final documents, as well as their compliance with relevant regulatory requirements, guidelines, and respective country’s applicable laws. The SCA ensures that contracts meet needs of both clients and clinical trial sites, protecting best interests of clients and the company (as applicable), while nurturing and maintaining positive relationships with clinical trial sites.

Key Accountabilities

• Draft, review and negotiate all site agreements including but not limited to clinical study agreements, service agreements, team member agreements and other types of related documents like letters, notices, etc.
• Provide context to comments received from sites in light of local legal and business framework, common practices, and past negotiation experience for the purpose of further review up the decisioning chain.
• Apply and scrutinize site contract and related documents and their revisions against negotiation and budget parameters (as applicable).
• 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 key communication liaison between site contracts staff and internal and external customers.
• Manage the contract execution process, including obtaining required signatures and ensuring timely execution of the document by all parties.
• Follow record maintenance and archival guidelines to ensure they are met.
• 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 that contract terms align with the overall trial goals and objectives.
• Identify potential issues or concerns with contract terms and collaborate with internal stakeholders and clinical trial sites to find mutually acceptable solutions.
• Stay up to date with relevant regulatory requirements, guidelines and applicable laws in respective country.
• Identify if all necessary documents, such as Power of Attorney, Insurance Certificates, Indemnification Letters, Informed Consent Form, referenced agreements or any other correlated documents are in line and in place for the need of Clinical Site Agreement.
• Track and report on the statuses of site contracting activities to Site Contract Lead, other internal stakeholders and study teams.
• Responsible for first time quality by self-check and reviews contracts for completeness and accuracy.
• Ensure that changes are appropriately made, approved and documented.
• Work within the forecasted country/site contracting timelines, ensure they are complied with and track milestone progress in agreed upon contract tracking system in real time.
• Identify possible contract or process operational risk and proactively work with SCL to provide solutions.
• Review and comply with Standard Operating Procedures (SOPs) and any other relevant applicable guidance in a timely manner.
• 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 in the respective country.
• Participate in cross-functional communication to identify process improvements and contribute to the development of site contracting strategies.

Qualifications

• Possess 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.
• Must have strong analytical skills with the ability to create or interpret legal language and budgets.
• Maintain grace under pressure while displaying a high level of professionalism.
• Align internal and external resources to achieve objectives.
• Attention to detail.
• Comprehend and interpret contract language.
• Identify problems independently and execute solutions.
• 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; command of additional languages is beneficial.

Knowledge and Experience

• Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint.
• SCA I is an entry-level role and does not require specific industry experience.

Education

• Bachelor's degree in a related field (e.g., law, economics, business, social sciences), equivalent training or industry experience.

EEO Disclaimer

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.