Scheduled Hours

40

Position Summary

The Cardiovascular Division in the Department of Internal Medicine at Washington University School of Medicine is seeking a highly organized and experienced Clinical Research Coordinator II (CRC II) to support funded global cardiovascular health research and research training initiatives. Working under the direction of the Principal Investigator (PI), the CRC II will independently coordinate and manage complex clinical research activities across multiple studies, ensuring regulatory compliance, data integrity, and efficient study execution.
This role serves as a key operational lead and liaison among the PI, study teams, institutional offices, sponsors, and external collaborators. The ideal candidate will be proactive, detail-oriented, and capable of managing competing priorities while supporting regulatory, administrative, financial, and operational aspects of clinical research projects.

Job Description

Primary Duties & Responsibilities:

Study Operations & Coordination

• Independently coordinate and manage day-to-day operations of multiple funded clinical research studies, including domestic and international projects.
• Implement and oversee all phases of assigned study protocols in accordance with institutional policies, study timelines, and regulatory requirements.
• Serve as a primary liaison between the PI, study teams, sponsors, collaborators, and institutional stakeholders.
• Coordinate study start-up activities, including protocol development, study materials, case report forms, and standard operating procedures (SOPs).
• Assist with training and oversight of research staff, students, and trainees involved in study activities.

Regulatory & Compliance

• Prepare, submit, and maintain regulatory documentation, including IRB applications, continuing reviews, amendments, reportable events, and protocol deviations.
• Ensure compliance with institutional, federal, and sponsor requirements, including ICH-GCP and NIH policies.
• Maintain accurate and organized regulatory binders and study records.
• Navigate and manage federal and institutional research platforms, including ClinicalTrials.gov PRS, eCONNECT, and other NIH systems, as applicable.
• Monitor study conduct and identify compliance issues; recommend and implement corrective actions in consultation with the PI.

Data Management & Reporting

• Oversee data collection, quality control, and documentation to ensure accuracy and completeness.
• Evaluate and interpret collected clinical and research data as appropriate.
• Prepare written and oral progress reports, summaries, and analyses for the PI, sponsors, and regulatory bodies.
• Assist with preparation of manuscripts, abstracts, and presentations for peer-reviewed publications and scientific meetings.

Financial & Administrative Support

• Assist with study budget development, tracking, and forecasting.
• Coordinate invoicing, subcontractor documentation, and expense reconciliation in collaboration with departmental and institutional partners.
• Support PI with administrative components of funded projects, including NIH RPPR-related documentation, as needed.

Additional Responsibilities

• Conduct literature reviews to support study planning and protocol development.
• Assist with grant proposal preparation and modifications to study design, as appropriate.
• Perform other duties as assigned in support of research and programmatic goals.

Working Conditions:

Job Location/Working Conditions

• Office space / dry lab

Physical Effort

• Typically sitting at desk or workstation

Equipment

• Standard office equipment

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.

Required Qualifications

Education:

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

Certifications/Professional Licenses:

The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certification or professional license may be required depending on the role.

Basic Life Support - American Heart Association, Basic Life Support - American Red Cross