Site Contract Associate

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.

• 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
• 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

• 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…