Site Contract Associate

Parexel • Denver, CO • 2h ago

Home Based, US

The Site Contract Associate II ("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 andbusiness 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

Serves as key communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.

Manage the contract execution process, including obtaining required signatures and ensuring timely execution of the document by all parties

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

Identifies 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

SCA is responsible for first time quality by self-check and reviews contracts for completeness and accuracy

Ensures that changes are appropriately made, approved and documented

Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon contract tracking system in real time

Reviews and complies with Standard Operating Procedures (SOPs) any other relevant applicable guidance in a timely manner, keeps training records updated accordingly and ensures 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 in the respective country

Participate in cross-functional communication to identify process improvements and contribute to the development of site contracting strategies

Skills:

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

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

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 II requires 2-5 years of experience in site contracting or combination with a related field within the CRO industry

Education:

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

LI-REMOTE

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.

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