Home Based, US

As a Site Contract Associate II you will oversee the site contracting process for clinical trials, ensuring that contracts are executed in a timely and effective manner. This is a clinical site facing role.

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.

If you have some experience negotiating and writing contracts this is an exciting opportunity to use this knowledge within Clinical Research.

Accountabilities:

• Monitor, drive, and report on site contract performance throughout the whole lifecycle, specifically metrics such as contract cycle times, contract aging time, contract quality and tracking compliance.
• Developing all Project set up documents for contracting, including but not limited to: CTA templates, Fallback languages, Site Contract Plan, etc.
• Advise on investigator grant budgets/parameters in collaboration with a global team of Grant Strategy and Investigator fees.
• Ensuring that all terms and conditions are clear, effectively aligned with the overall project needs.
• Participate on KOMs to provide feedback on preferable contracting strategies and beneficial tactics.
• Oversee project specific Site Contracts team, providing leadership, guidance, and necessary project/client specific training to the team members.
• Develop and implement best practices for site contract management including specific processes, procedures, and tools
• May support the department through shared knowledge and other define pathways, as well as deescalate issues.
• Conscientiously control the budget from a site contracting aspect, ensuring that costs are tracked, managed, and communicated timely and effectively.
• Identify and mitigate risks associated with the site contracting process, including risks related to timelines, costs, effectiveness of implemented strategy, and quality. Collaborate with all relevant stakeholders until resolution.
• Maintain frequent, clear and effective communication with all stakeholders involved with or dependent upon the site contracting process, including sponsors, key internal stakeholders, vendors, collaborative CROs and sites (as applicable)
• Build and maintain strong working relationships with external and internal stakeholders, and facilitate alignment of relevant parties aiming at expedited contract execution,
• Provide necessary support to cross-functional teams including Start up, Global Clinical Operations, Investigator Payments, Business Development and Feasibility
• Provide regular updates and reports on the site contracting process to clients, senior management and other stakeholders as needed.
• Monitor data accuracy and completeness.
• Support Project Lead with implementation of project hour forecasting for Site Contracts team to ensure accurate planning, resource allocation and budgeting throughout trial lifecycle.

Skills

• Strong negotiation, diplomacy, team leadership skills, and excellent organizational ability
• Ability to successfully work in a “virtual” team environment
• Ability to complete tasks in an accurate, timely manner and effectively manage multiple tasks
• Effective time management in order to meet daily metrics or team objectives
• Ability to take initiative, work independently and delegate

Requirements

• Fluency in written and spoken English.
• Bachelor's degree in a related field (e.g., law, economics, business, social sciences), equivalent training or industry experience.
• Experience in negotiating and writing contracts
• Experience in team coordination