Contract Specialist I

Clinical Operations Research Triangle Park, North Carolina


Description

Position at Premier Research Group Limited

Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.

We’re looking for a talented and energetic Contract Specialist to join our team!

Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!

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.

The Contract Specialist

  • 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.
  • 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.
  • Provides training on clinical site contractual requirements and negotiation.
  • Participates in corporate initiatives and actions that ensure the continued success of the company.

 EDUCATION AND EXPERIENCE

  •  Undergraduate degree or its international equivalent in business administration, legal studies or life sciences from an accredited institution.
  • At least 1 year of legal experience with contract language, budget development and negotiations
  • At least 1 year of related industry experience (CRO preferred)
  • Ability to work with internal and external customers/vendors to meet project-specific goals
  • Interacts with site, clients and other functional areas as secondary project contact for contracting issues and questions
  • Manages time and project requirements base on study deliverables