Specialist-Clinical Research Study Start-Up

Job Requirements Position SummaryThe Clinical Research Study Start-Up Specialist is responsible for leading and coordinating all activities associated with the initiation of clinical research studies from feasibility through site activation. This position ensures studies are initiated efficiently, compliantly, and within established timelines by partnering with investigators, sponsors, CROs, and institutional departments.The Clinical Research Study Start-Up Specialist manages a portfolio of concurrent study start-ups of varying complexity, including industry-sponsored Phase I–III trials, cooperative group studies, and investigator-initiated research. This position operates with a high degree of independence and serves as a subject matter expert for study start-up processes across multiple study types.This position interfaces regularly with external sponsors and internal departments such as office of research compliance, IT Security, and Institutional Review Board (IRB), and directly impacts study activation timelines, regulatory compliance, and financial readiness.The Clinical Research Study Start-Up Specialist plays a critical role in supporting principal investigators, research teams, sponsors, and regulatory bodies to ensure studies are activated efficiently and in accordance with institutional, federal, and sponsor requirements. This position directly contributes to reducing activation timelines, ensuring financial feasibility, and supporting organizational accrual and revenue goals.Minimum RequirementsEducation Bachelor’s degree (BA/BS/BSN or related health/science field) requiredExperience Minimum of 2 years of clinical or clinical research experienceLicense/Registration/Certifications ·N/APreferred RequirementsPreferred Education Master’s degree in a health-related fieldPreferred Experience Experience with clinical trial processes or study coordination to demonstrate readiness for start-up responsibilities3 to 5+ years of clinical research experience with direct study start-up responsibilitiesOncology research experienceExperience with clinical trial management systems (e.g., OnCore) and electronic regulatory systemsPreferred License/Registration/Certifications Certification in research (CCRC, CCRP)Core Job ResponsibilitiesStudy Start-Up ExecutionLead and manage study start-up activities from feasibility through site activationConduct feasibility assessments and develop start-up timelines in collaboration with investigators and study teamsManage a portfolio of concurrent trials of varying complexity, ensuring prioritization and timely executionTrack study start-up milestones and escalate risks or delays with recommended mitigation strategiesRegulatory & CompliancePrepare and track documents submitted to the Protocol Review CommitteeResponsible for the preparation and submission of materials for institutional and ancillary committee reviewEnsure compliance with institutional policies, federal regulations (FDA, OHRP), and GCP guidelinesFinancial & Contracting SupportServe as a liaison between clinical research, finance, and contracting teams to facilitate timely completion of Coverage Analysis (CA) for research studiesCoordinate with contract management team members to track the progress of study budgets, agreements, and contract negotiationsMonitor and maintain status updates for financial and contracting workflows, ensuring key milestones are met and stakeholders are informed of progressContribute to process improvement initiatives to enhance efficiency, transparency, and turnaround times for coverage analysis and contracting activitiesStakeholder CollaborationServe as a primary point of contact for sponsors, CROs, investigators, and internal stakeholders during study start-upProvide subject matter expertise and guidance to research teams on start-up processes, timelines, and compliance requirementsServe as a resource and mentor to research staff on study start-up best practicesOperational PerformanceTrack, analyze, and report study start-up metrics, including activation timelines and regulatory submission turnaround timesIdentify process improvement opportunities and implement strategies to enhance study activation efficiencyJob SummaryJob number: P-107777Profession: Clinical Research Careers