Site Contracts Specialist II

Everest Clinical Research•Bridgewater Township, NJ

6d•$70,000 - $85,000•Hybrid

About The Position

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO, including clinical operations. Everest’s headquarters are located in Markham Ontario, Canada with additional locations in: Bridgewater, New Jersey; Shanghai, China; Taipei, Taiwan; and multiple offices in Europe. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest. To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a Site Contracts Specialist II for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA or Canada in accordance with our Work from Home policy.

Requirements

Bachelor’s degree or international equivalent in a related field such as science/biology or English/communication
2+ years of investigative site contracting experience with both the legal language and the budget.

Nice To Haves

Master's or JD preferred

Responsibilities

Supporting the site start up process of clinical studies by negotiating and executing Clinical Trial Agreements and their budgets.
Ensuring the quality and timeliness of negotiations.
Timely site follow ups, touching base with sites every 5 business days or every 3 business days for sites chosen as a priority.
Asking questions of senior negotiators.
Communicating professionally with investigative sites or sponsors via email or telephone.
Being assigned sites from several studies to gain experience in different therapeutic areas.
Reporting status updates to the Site Contracts Manager or Study Team as applicable.
Escalating any language or budget costs for review and approval.
Raising any changes in site circumstances as they arise that may delay critical timelines to Site Contracts Manager as well as the study team.
Understanding which sites are designated as a priority and working with the Site Contracts Manager or study team to ensure the contracts are executed in a timely manner.
Performing in a fast-paced environment, creating and resetting priorities as the need arises, identifying and raising issues before they become critical, and adjusting quickly to the changes of a dynamic organization.
Participating in a project team to deliver contract and budget services on time, within budget, and in accordance with applicable financial, contractual, and pharmaceutical research and development industry standards and regulations.
Ensuring the successful negotiation and on-going management of clinical trial agreements with investigative sites located in the US and Canada.
Working in many different treatment areas.
Negotiating study-specific Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), Amendments or other related contractual documents and following the escalation processes as established with the client.
Reviewing site budget templates for accuracy against the protocol and foreseeing potential issues in negotiations.
Understanding or being willing to learn site budgets and identifying items that would not be applicable to a study and pushing back on unnecessary, or higher than FMV, requests.
Appraising contracts for completeness and accuracy and ensuring adherence to guidelines, correcting documents, ensuring proper formatting, spelling, and professional presentation of the contract language.
Tracking all site interaction in a timely and accurate manner and ensuring that status updates to the client are fully descriptive.
Forecasting and tracking the negotiation timelines and ensuring targets or milestones are achievable.
Escalating any issues to the Site Contract Manager and study team that may delay projected execution timelines or scheduled SIVs.
Working cross-functionally with Clinical Operations and Project Management in support of timely site start-up for the conduct of clinical trials including accurate forecast of contract execution timelines.
Identifying and proactively raising issues to Site Contract Manager and study team, as appropriate, prior to their becoming critical or creating risk.
Identifying those elements that trigger an out-of-scope activity (i.e. additional tasks requested, timeline shift, sites added to the study) and working with the study team to prepare Change Orders as needed.
Performing other duties as assigned.