Contract Specialist I

Study Start Up Remote, North Carolina


Position at Premier Research

Contract Specialist I:

* Is responsible for preparing, negotiating, tracking and finalizing the Confidentiality Agreements (CDA), Clinical Trial Agreements (CTA), Budgets and Letters of Indemnification (LOI) as well as Amendments to these documents, as needed.

* Negotiates final CDA and CTA templates with clients, and the internal project team.

* Manages all required contractual agreements with investigator sites. This includes distribution, negotiation of budget and language, tracking and finalization.

* Independently communicates with client designee on all contract-related items.

* Escalates issues appropriately to the Project Manager.

* Proactively identifies site contract related risks and potential roadblocks.

* Prepares contract approval timelines with investigators and leads efforts to obtain contract approval to meet study deliverables.

* Participates in project-related meetings.

* Maintains communication with client, project team and sites regarding status of all contractual requirements.

* Assists in development and implementation of new initiatives and negotiation/execution processes.

* Collaborates with the project team to ensure the client deliverables and expectations are achieved.

* Provides a handoff to the project team upon execution of a site’s final contractual documents.


* Liaises with internal customers to review contract or budget areas that impact final execution of site contracts.

* Maintains tracking regarding site contracts and provides regular updates as agreed by the study team to the project team and client regarding status and efforts to ensure timelines are maintained.

* Ensures that Premier Research, clinical investigators, institutions and our clients have contractual agreements in place that are clear, fair and legally binding.

* Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to CDAs, CTAs, investigator grants, and LOIs.

* Provides training on clinical site contractual requirements and negotiation.

* Mentors and trains junior level staff.

* Participates in corporate initiatives and actions that ensure the continued success of the company.

* Provides performance feedback on project team members for annual appraisals.

* Other activities as designated.