Clinical Research

• Own and manage the study start-up process from study award or feasibility through site activation and readiness for first patient enrollment.
• Develop study start-up plans, timelines, milestones, and deliverables.
• Coordinate regulatory, contracts, budgets, clinical operations, finance, recruitment, technology, and other functional teams.
• Track feasibility, regulatory submissions, IRB approvals, contracts, budgets, training, system readiness, and sponsor requirements.
• Ensure documentation, approvals, and operational requirements are completed before site activation.
• Identify critical-path activities, dependencies, potential delays, and mitigation plans.
• Serve as the central coordination point for internal departments, sponsors, CROs, vendors, and site leadership.
• Lead start-up meetings, assign action-item owners, and ensure follow-through.
• Escalate risks, delays, and unresolved issues with recommended solutions and recovery plans.
• Build and maintain project plans, start-up trackers, milestone records, and status reports.
• Coordinate operational readiness, including staffing, training, supplies, systems, and documentation.
• Verify readiness of CTMS, eRegulatory, eSource, EDC, and other study systems.
• Ensure alignment with GCP, regulatory requirements, sponsor expectations, and organizational SOPs.
• Support handoffs from study start-up to ongoing clinical research operations.
• Provide structured stakeholder updates and facilitate meetings with documented decisions, owners, and due dates.
• Improve workflows, handoffs, processes, and study activation cycle times.
• Drive on-time study activation, milestone adherence, risk resolution, project visibility, accountability, and continuous improvement.

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