Clinical Research Project Manager - Infectious Diseases Saint Louis, MO

Clinical Research Project Manager
- Infectious Diseases

Washington University. Saint Louis, MO.

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This position will play a key role in expanding and managing clinical research activities led by Dr. Barbara Trautner. The position will be responsible for developing clinical trial protocols, working closely with investigators to design feasible, compliant studies that align with scientific goals. It will oversee daily operations of Dr. Trautner's research portfolio, ensuring studies are executed in compliance with institutional expectations.

It will also serve as a liaison between WashU and partner research sites, building strong collaborations with site investigators and clinical teams to support successful study execution across study‑involved locations. The role will contribute to grant writing, reporting and communications, assisting with annual reports to funders such as AHRQ, the Neilsen Foundation, and VA R&D, and supporting manuscript and abstract tracking for all research output.

It will also organize study‑specific meetings, facilitate coordination across teams, and help ensure that deliverables are met on time.

• Manages full scope of study conduct, in collaboration with Administrative Operations, to ensure studies are conducted according to the Code of Federal Regulations, Good Clinical Practices, local regulatory requirements and Washington University SOPs.
• Collaborates with all relevant groups to develop and manage clinical project timelines.
• Coordinates and leads meetings with all study team members.
• Plans and participates in investigator meetings, in collaboration with all cross‑functional team members.
• Disseminates clinical project communications to all functional groups, as appropriate.
• Contributes to protocol synopsis development and Clinical Operations feasibility assessments.
• Writes study protocols, amendments and administrative changes based on approved protocol synopsis.
• Provides oversight of subcontracts (biomarkers, imaging, data management) which includes communicating expectations and timelines, ensuring deliverables are on time, with no quality issues.
• Determines staffing needs for all projects.
• Ensures training of study team, all performance sites and Cores/Components on study protocol and expectations.
• Provides input to problem‑solving and implements corrective action plan when necessary.
• Partners with Administrative Operations and Project Leaders, where applicable, to resolve performance site issues.
• Partners with Administrative Operations, Project Leaders and subcontractors (biomarkers, imaging, data management) for resolution of corrective actions as a result of QA audit and/or regulatory inspections.
• Escalate issues relevant to medical personnel as appropriate for medical monitoring, safety, and exemptions/deviations.
• Manages timelines and maintain project tracking system with current study status and provide accurate progress reports on assigned studies as requested.
• Helps to conceptualize and submit new grant proposals.
• Helps to manage budgets/funds.
• Assists with manuscript preparation and submission.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

• Normal office environment.

• Typically sitting at desk or table.

• Office equipment.

• Education: Bachelor's degree
• Certifications: No specific certification is required for this position.
• Work Experience: Clinical Research And Program…