Specialist-Clinical Research Study Start-Up

Spartanburg Regional Healthcare System•Greer, SC

About The Position

The 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.

Requirements

Bachelor’s degree (BA/BS/BSN or related health/science field) required
Minimum of 2 years of clinical or clinical research experience

Nice To Haves

Master’s degree in a health-related field
Experience with clinical trial processes or study coordination to demonstrate readiness for start-up responsibilities
3 to 5+ years of clinical research experience with direct study start-up responsibilities
Oncology research experience
Experience with clinical trial management systems (e.g., OnCore) and electronic regulatory systems
Certification in research (CCRC, CCRP)

Responsibilities

Lead and manage study start-up activities from feasibility through site activation
Conduct feasibility assessments and develop start-up timelines in collaboration with investigators and study teams
Manage a portfolio of concurrent trials of varying complexity, ensuring prioritization and timely execution
Track study start-up milestones and escalate risks or delays with recommended mitigation strategies
Prepare and track documents submitted to the Protocol Review Committee
Responsible for the preparation and submission of materials for institutional and ancillary committee review
Ensure compliance with institutional policies, federal regulations (FDA, OHRP), and GCP guidelines
Serve as a liaison between clinical research, finance, and contracting teams to facilitate timely completion of Coverage Analysis (CA) for research studies
Coordinate with contract management team members to track the progress of study budgets, agreements, and contract negotiations
Monitor and maintain status updates for financial and contracting workflows, ensuring key milestones are met and stakeholders are informed of progress
Contribute to process improvement initiatives to enhance efficiency, transparency, and turnaround times for coverage analysis and contracting activities
Serve as a primary point of contact for sponsors, CROs, investigators, and internal stakeholders during study start-up
Provide subject matter expertise and guidance to research teams on start-up processes, timelines, and compliance requirements
Serve as a resource and mentor to research staff on study start-up best practices
Track, analyze, and report study start-up metrics, including activation timelines and regulatory submission turnaround times
Identify process improvement opportunities and implement strategies to enhance study activation efficiency