Contract Specialist I
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.