Contract Specialist I

Study Start Up Morrisville, North Carolina


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

 We’re looking for an exceptional Contracts Specialist to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

 At Premier Research, we are science-minded and heart-centered. Join us.

The Contract Specialist is responsible for all aspects of preparation, negotiation and execution of required contractual agreements associated with an investigative site participating in a clinical study. The Contract Specialist assumes responsibility on quality deliverables throughout the conduct of the study with a concentration on Site Start Up and up to Site initiation.

* 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.

RESPONSIBILITIES:

* 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.

EDUCATION, SKILLS & COMPETENCIES:

* Undergraduate degree or its international equivalent in business administration, legal studies or life sciences from an accredited institution.