Neurosciences Clinical Trials Unit

NCTU conducts an internal feasibility review for every new study to ensure adequate staffing, resources, space, and financial viability. This evaluation begins after receipt of study documents and runs parallel to sponsor and regulatory processes.

Our team partners with PIs to:

• Estimate coordinator effort and enrollment expectations
• Develop staffing plans, including hiring when needed
• Assess bandwidth and prevent direct competition between similar studies
• Provide guidance for investigator‑initiated or non‑industry projects
• Coordinate contract execution with OSP and FiRST

Studies that are low‑risk and underfunded may be eligible for an NCTU involvement waiver, while others may be referred to the Research Coordination & Management Unit (RCMU).

Every study supported by NCTU includes professional clinical research coordination services. Coordinators are trained to manage every aspect of the study lifecycle, including:

• Screening, consenting, and study visits
• OnCore data entry, participant tracking, and invoiceable items
• Regulatory submissions in Veeva (IRB, amendments, protocols, DUAs, MTAs)
• Biospecimen handling and documentation
• Study‑specific communication and project detail tracking

NCTU ensures appropriate backup coverage within pods to maintain continuity when staff are out of office.

NCTU works closely with FiRST to ensure clear, sustainable budgeting for every clinical trial.

Our commitments include:

• Itemized, transparent budgets (no lump sums accepted)
• Realistic effort projections for faculty and coordinators
• Monthly financial reviews to monitor study health
• Early intervention if a study approaches a deficit
• Support for PI‑funded continuation of otherwise unsustainable studies

Residuals are reinvested in research activities, bridging funds, and professional development.

Successful trial execution depends on partnership. NCTU asks investigators to:

• Provide and regularly update availability and preferred contact methods
• Maintain an up‑to‑date CV
• Notify NCTU early about new studies or anticipated hires
• Review adverse events in real time or within 5 business days
• Complete required CITI and COI training
• Attend or review NC TraCS Clinical Trialist Bootcamp if research effort ≥10%
• Offer constructive, timely feedback for coordinators

NCTU is organized into pods — small teams of 3–8 coordinators led by a pod manager. Pod managers:

• • Oversee study operations
  • Serve as the primary point of contact for investigators
  • Provide onboarding and mentorship
  • Coordinate their own study portfolios
  • Assist with performance reviews and staffing decisions

To ensure clarity and accountability:

• Written communication is preferred whenever possible
• Meeting agendas should be provided in advance
• Updates on enrollment, activation status, and study issues are sent periodically to division chiefs and investigators

Concerns should be routed to pod managers first, with escalation to NCTU leadership as needed.

Mistakes are expected in a learning environment. NCTU promotes:

• A just culture where errors are reported without fear
• Structured processes for feedback and remediation
• Training and credential maintenance for all coordinators
• Transparent documentation in OnCore and Veeva
• High efficiency in meetings and study workflows