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Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise
Senior Contracts Specialist
Department of Clinical Research Administration
This position, under the direction of the Senior Director of Clinical Research Administration and the guidance of HSS Legal Affairs, is responsible for preparation, negotiation, and execution of clinical research agreements including confidentiality agreements (CDAs), clinical trial agreements (CTAs), service agreements (SAs), data use agreements (DUAs), master agreements, subcontract agreements, collaboration agreements, amendments, and other clinical research agreements as assigned on behalf of HSS while working with HSS Legal Affairs, Clinical Research Administration (CRA), and cross-functional departments/service lines to effectively meet deliverables.
The Senior Contracts Specialist must be able to 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.
Responsible for performing job duties in accordance with the mission, vision, and values of HSS, Clinical Research Administration and the Office of Legal Affairs.
- Drafts, negotiates, and executes clinical research CDAs, CTAs, SAs, DUAs, master agreements, subcontract agreements, collaboration agreements, amendments, and other clinical research agreements as assigned in accordance with HSS clinical research agreement policies and guidelines.
- Facilitates the clinical research agreements process by reviewing and negotiating agreements in coordination with HSS CRA, Legal Affairs, and cross-functional departments/service line research liaisons to ensure execution of timely agreements.
- Reviews sponsor research agreement templates and edits as appropriate to ensure HSS positions are incorporated into agreements per guidance provided by Legal Affairs and CRA.
- Negotiates clinical research agreements as appropriate to ensure alignment with HSS positions.
- Escalates issues and seeks advisement from HSS Legal Affairs, CRA, and other subject matter experts with guidance from HSS Legal Affairs and CRA to ensure appropriate contract language.
- Ensures agreements are processed within CRA defined contract negotiation and execution timelines; proactively follows up with all parties involved to ensure timely agreement executions.
- Ensures clinical research agreement language is consistent with IRB approved consent form related to subject injury.
- Ensures CRA approved budget and payment terms are incorporated into final clinical research agreements, if applicable, prior to contract execution.
- Maintains up-to-date tracking of all clinical research agreements and client correspondence and provides periodic internal updates.
- Ensures clinical research agreement current statuses are documented in HSS database.
- Collaborates via phone, email, and in-person meetings with internal and external stakeholders to ensure clinical research agreement statuses are reported as requested.
- Adheres to HSS high service level response times.
- Provides administration support from clinical research agreement initiation to execution for all clinical research agreements, including facilitating signatures and providing back-up support to Legal Affairs when appropriate.
- Coordinates efforts, as directed, among HSS, HSS clients, suppliers, outside counsel, and/or consultants to facilitate timely execution of clinical research agreements.
- Manages dissemination and filing of clinical research agreements.
- Assists with clinical research agreement termination when applicable.
- Generates ad hoc reports, participates in special projects, and performs other related duties as assigned.
- Bachelor's degree, Master's degree preferred.
- Advanced legal training/coursework preferred.
- Knowledge of healthcare and/or clinical research administration experience preferred.
- Knowledge of contract management principles with two (2) to five (5) years' of with prior clinical research
- Ability to read, analyze, and interpret contractual documents and technical procedures.
- Highly organized with excellent oral, written communication skills, and strong computer skills.
- Self-starter with a demonstrated ability to achieve results as part of an effective team.
- Ability to effectively present information and respond to questions from internal and external clients.
- Ability to solve practical problems and deal with a variety of variables in situations.
- Demonstrates effective time management skills and ability to self-prioritize multiple tasks as assigned
- Ability to work independently and work as part of a project team.