Clinical Research Contract and Start Up Specialist

• Liaises and establishes effective relationships with sponsors, study teams, and ancillary stakeholders.
• Prepares and negotiates study and vendor contracts, as well as awards clinical research studies within the contract management system.
• Works directly with sponsors, academic collaborators, and other parties to resolve research contract issues. Ensures quality, objectivity, and risk analysis in the efficient delivery of contracts.
• Ensures alignment of the contract consultation process for teams and study is properly aligned to the critical path for site activation

20%
Preparing and reviewing budgets and other supporting documents

• Prepares and reviews budgets, templates, and supporting documents.
• Identifies and assesses legal, financial, and operational risks and raises them to the appropriate level of the organization per established processes

30%
Regulatory documentation and IRB applications Reporting:

• Oversee ethics and regulatory bodies’ submissions and approval status. Coordinate addressing queries and ensuring required timelines are met. Communicates with sponsors about regulatory information.
• Prepares and reviews Informed Consent Forms and other regulatory documents per federal, state, and institutional guidelines.
• Responds to ancillary queries in a timely manner, revises IRB application as needed, and submit amendments and protocol deviation information when required.
• Assists with study regulatory maintenance.

20%
Communication and Oversight:

• Maintains documentation of contracts, IRB application status, and other KPIs, tracks metrics and outcomes, and produces related reports. Consult and collaborate with the clinical research management team to ensure clinical research studies remain on track for timely start-up and initiation.
• Demonstrates a customer-focused style of communication, problem-solving and collaboration
• Communicates, receives, and understands information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Performs successfully under pressure while prioritizing and handling multiple projects or activities.
• Coordinates with internal functional departments to ensure various startup activities are aligned with contractual activities and mutually agreed-upon timelines.
• Maintains documentation of contracts, IRB application status, and other KPIs, tracks metrics and outcomes, and produces related reports.
• Conducts process improvement through evaluation of workflows, development of documentation, and communication with key stakeholders.

CLINICAL SUPPORT POSITION – NOT SUBJECT TO STATE HUMAN RESOURCES ACT.
The Brody School of Medicine at East Carolina University is affiliated with ECU Health Medical Center, which serves as its teaching hospital, as well as the flagship hospital for ECU Health.

• Please ensure your full range of knowledge, skills, abilities, experience and education are listed on your application. Do not write ‘see resume’ on your application when completing the job duties section.
• If you answer the questions at the end of the application, please ensure your application reflects the knowledge, skills, abilities and experiences to support your answers (see job duties section of previous employment).
• Failure to answer the questions at the end of the application will not preclude your application from being considered but may result in your application not receiving full consideration of your knowledge, skills, and abilities.
• Applicants must be currently authorized to work in the United States on a full-time basis.