Senior Specialist, Site Contracts

Location: Northern

## Senior Specialist Apply:
Remote:
Durham, North Carolina:
Full time:
Posted Today:
JR102948

Who we areWe’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

Join us!
** What the Sr. Specialist, Site Contracts does at Worldwide
** Senior Specialist, Site Contracts is responsible for developing, reviewing, and assisting with the negotiation of Site Agreements with Institutions and Investigators and providing oversight and expertise to all site contract activities during all stages of a Clinical Trial. This includes the development of investigator grants, Clinical Trial Agreement templates and applicable plans, negotiation of Clinical Trial Agreements and ancillary agreements, and mitigation of site contracting risks.
** What you will do
*** Prepare country contract templates
* Draft and send Site Agreements or any contracts associated with sites to begin negotiations
* Provide site contract execution planned timelines and site negotiation status
* Send items for translation, if applicable, and receive and translate items
* Review study budgets and costs pertaining to contract negotiation
* Negotiate contract language and budgets with each assigned site through finalization and execution
* Escalate sponsor site requests outside of preapproved parameters
* Escalate risks and non-responsive sites to the Site Contracts Lead or internal team, as applicable
* If required to provide equipment to sites, ensure appropriate information or appendices are added to Site Agreements or associated documents
* Create donation agreements, as applicable
* Review Site Agreements or any associated contracts for completeness and accuracy
* Finalize contracts and budgets with sites
* Perform quality checks of Site Agreements or associated contracts before the signature process begins
* If requested, provide draft or signed contracts and budgets to the regulatory team for submission purposes, where needed
* Liaise with Worldwide Clinical Trials Legal Department, Data Privacy team, study teams, sponsors, sites, investigators, and other stakeholders
* Facilitate contract signatures by Worldwide Clinical Trials, when applicable
* Send fully executed Site Agreements or associated documents to sites, electronic Trial Master File (eTMF), payment team, sponsors, and post to internal SharePoint, as applicable
* Negotiate Site Agreement amendment language and budgets with sites
* Create termination letters and send them to sites for signature, as applicable
* Maintain tracking tools with live, real-time updates for functional activities
* Prioritize effectively and respond to urgent requests within the internal team or sponsor
* Review Trial Master File (TMF) structure, oversee Investigator Grants Budgets, and ensure quality checks for site agreements
* Act as a lead and subject matter expert on site agreements and related processes, prepare and update contract templates, coordinate master budgets and contract and budget plans, send these to the sponsor, and manage site agreements
* Maintain tracking tools, communicate site contracting strategies, timelines, and tracking requirements, and escalate issues as necessary
* Develop mitigation plans, resolve contract negotiation issues, and contribute to process improvement initiatives
* Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not…