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
SeniorSite Contracts Specialist working remotely (or in office).
Position Objective: The Senior Site Contracts Specialist is responsible for independently leading the negotiation, execution, and management of Clinical Trial Agreements and associated study budgets to support timely study startup and execution. This role serves as a key liaison between investigative sites, sponsors, and study teams, ensuring high-quality contractual deliverables, adherence to project timelines, and effective issue resolution. The Senior Site Contracts Specialist provides mentorship and training to junior staff, supports quality control and process improvement initiatives, and proactively identifies and escalates contractual, budgetary, and site-related risks to facilitate successful study outcomes.
Key Accountabilities:- Perform in a fast-paced environment, create and reset priorities as the need arises, identify and raise issues before they become critical, and adjust quickly to the changes of a dynamic organization.
- Participate 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.
- Ensure the successful negotiation and on-going management of clinical trial agreements with investigative sites located in the US and Canada.
- Oversee negotiations in other countries as needed.
- Be willing to work in many different treatment areas.
- Negotiate study-specific Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), Amendments or other related contractual documents and follow the escalation processes as established with the client.
- Review site budget templates for accuracy against the protocol and foreseeing potential issues in negotiations.
- Support contract template development for new studies.
- Understand or be willing to learn site budgets and identify items that would not be applicable to a study and push back on unnecessary, or higher than FMV, requests.
- Appraise contracts for completeness and accuracy and ensure adherence to guidelines, corrects documents, ensure proper formatting, spelling, and professional presentation of the contract language.
- Track all site interaction in a timely and accurate manner and ensure that status updates to the client are fully descriptive.
- Forecast and track the negotiation timelines and ensure targets or milestones are achievable.
- Escalate any issues to the Site Contract Manager and study team that may delay projected execution timelines or scheduled SIVs.
- Work 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.
- Identify and proactively raise issues to Site Contract Manager and study team, as appropriate, prior to their becoming critical or creating risk.
- Act as a subject matter expert in review of contract training materials.
- Support process improvement initiatives within the site contracts team.
- Identify those elements that trigger an out-of-scope activity (i.e. additional tasks requested, timeline shift, sites added to the study) and work with the study team to prepare Change Orders as needed.
- Other duties as assigned.
Qualifications and Experience:- Bachelor's degree or international equivalent in a related field such as science/biology or English/communication; Master's or JD preferred.
- 3+ years of investigative site contracting experience with both the legal language and the budget.
Benefits & Compensation: We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a 401(k) retirement, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com
Estimated Salary Range: $85,000 - $105,000
We thank all interested applicants, however, only those selected for an interview will be contacted.
