Clinical Research Study Startup and Contract Specialist

Clinical Research Study Startup and Contract Specialist

Position Number: 946603
Full Time or Part Time: Full Time
Anticipated Recruitment Range: $41,379 - $67,980
Position Type: Non-Faculty
Job Category: Non-Faculty Professional

Organizational Unit Overview:

It is the mission of East Carolina University (ECU) Brody School of Medicine (BSOM) and ECU Health to provide exemplary medical education/training for physicians at the undergraduate and graduate levels. Additionally, it is the mission of BSOM to provide model comprehensive primary and consultative subspecialty care to patients in eastern North Carolina, to advance scientific knowledge through basic, translational, and clinical research, and to provide continuing medical education opportunities for physicians in the region.

The Office of Clinical Research (OCR) encompasses the pre-award, post-award, and clinical operation activities related to industry-sponsored clinical research, including clinical trials, for the Brody School of Medicine (BSOM) and ECU Health. The Director of OCR reports to the BSOM Associate Dean for Research, who also holds the role of Associate Chief of Clinical Research and Research Strategy in the Office of Research, REDE at ECU. Importantly, the Associate Chief of Clinical Research and Research Strategy also oversees clinical research for ECU Health to facilitate clinical research integration across institutions. The vision for OCR is to expand and manage all industry-associated clinical research projects across ECU and ECU Health after additional needed financial and staff resources become available.

Job Duties:

The Brody School of Medicine (BSOM) Clinical Research Office (CRO) within the department of Research and Graduate Studies at East Carolina University is seeking a (12-month, AT WILL) Clinical Research Study Startup and Contract Specialist. The Contract Specialist will aid in streamlining the study startup process for clinical research studies at ECU and ECU Health by working closely with the study sponsors, research teams, and the UMCIRB office. This team member will manage a portfolio of departments within the enterprise and support investigators and research support staff in these departments with the study start-up process. This team member will assist with the development of site activation strategies and startup workflows and will oversee startup delivery and governance. This position will be responsible for negotiating, executing, and awarding contracts; preparing and reviewing budgets and other supporting documents; assisting with regulatory documentation and IRB applications; and training research support staff.

30% Negotiating, executing, and awarding contracts:

• 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 studies, which are properly aligned to the critical path for site activation.

30% Regulatory documentation and IRB applications Reporting:

• Oversee ethics and regulatory bodies submissions and approval status. Coordinate addressing queries and ensure required timelines are met. Communicates with sponsors around regulatory information.
• Prepares and reviews Informed Consent Forms and other regulatory documents per federal, state, and institutional guidelines.
• Responds to ancillary queries promptly, revises IRB application as needed, and submits 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.

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.

Contingent Upon Availability of Funds

Minimum Education/Experience:

Bachelors degree and one year of experience related to the area of assignment; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

License or Certification Required by Statute or Regulation:

None

Preferred Experience, Skills, Training/Education:

An understanding of policies and procedures related to clinical research is preferred. Experience in clinical research contract negotiations is highly desirable. Experience as a regulatory coordinator, a clinical research coordinator, or a paralegal is desirable.