Location
SAINT LOUIS, MO 63110
Scheduled Hours
40
Position Summary
Responsible for the advanced operational planning, oversight, and strategic execution of complex, interdisciplinary clinical research studies spanning multiple departments, sites, and/or institutions. Serves as a senior subject matter expert and primary point of accountability for all aspects of study conduct, quality, and compliance. Provides mentorship and direct supervision to junior research staff. Leads the development of new grant proposals, manages complex study budgets, and plays a central role in disseminating research findings through publications and presentations. Represents the research program to external stakeholders, funding agencies, and regulatory bodies.
Job Description
Primary Duties & Responsibilities:
May perform duties inclusive of those delegated to a Clinical Research Project Manager I.
Leads the full scope of multiple concurrent, complex clinical research studies, ensuring studies are conducted according to the Code of federal Regulations, Good Clinical Practices, local regulatory requirements and Washington University SOPs.
Serves as the primary operational lead and institutional representative for assigned studies, acting as the central point of contact for sponsors, regulatory agencies, and collaborative partners.
Develops, implements, and continuously refines study-wide operational strategies, timelines, and quality frameworks in collaboration with PIs, co-investigators, and central research administration units.
Maintains current knowledge of evolving domestic and international clinical research regulations and guidance documents, and applicable state and local requirements; proactively conducts gap analyses to assess the impact of regulatory changes on the assigned studies and the broader research program; develops, implements, and monitors corrective systems, updated SOPs, and training initiatives to close identified gaps and ensure sustained compliance across all sites and functional teams.
Demonstrates working knowledge of international clinical research regulations and guidelines applicable to assigned studies, and other country-specific requirements; advises study teams on when and how international requirements apply – particularly in multi-national trials or studies with international data transfer, biologics, or device components – and coordinates with regulators affairs and legal counsel as needed to ensure compliant study conduct across all applicable jurisdictions.
Leads investigator meetings, kick-off meetings, and cross-functional study team meetings; serves as the primary facilitator for complex multi-site coordination efforts.
Takes primary responsibility for protocol development, including drafting and finalizing study protocols, amendments, informed consent documents, and administrative changes; reviews submissions prepared by junior staff.
Leads feasibility assessments and contributes substantively to the development and writing of new grant proposals, including budget justifications, specific aims, and research strategies.
Manages complex study budgets and funds independently, including oversight of subcontract budgets, reconciliation, forecasting, and reporting to funding agencies; identifies and resolves budget discrepancies.
Directs staffing planning for all assigned projects.
Designs and leads comprehensive training programs for study teams across all performance sites and Cores/Components, ensuring uniform understanding of protocol requirements and institutional expectations. .
Independently identifies, evaluates, and resolves complex study related problems; develops and implements corrective action plans resulting from QA audits, regulatory inspections, or performance issues.
Oversee internal quality control systems and conducts regular audits of study conduct, data quality, and regulatory documentation across the portfolio.
Manages timelines and maintains project tracking systems across a portfolio of…