Clinical Research Coordinator II - Cardiology

Washington University in St. Louis • Ann Arbor, MI

23h • Onsite

About The Position

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.

Requirements

• Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
• Basic Life Support certification must be obtained within one month of hire date.
• Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirement).
• 2 Years of Clinical Research experience.

Nice To Haves

• Clinical Research
• Clinical Study Protocols
• Database Management
• Research Projects
• Spreadsheet Analysis
• Statistical Analysis Software (SAS)

Responsibilities

• 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 identifying and setting up data and safety monitoring board (DSMB) as needed, with development of documents such as the data and safety monitoring plan (DSMP).
• Assist with training and oversight of research staff, students, and trainees involved in study activities.
• 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, and report safety outcomes as stipulated by the DSMP
• 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.
• 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.
• 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.
• 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.

Benefits

• Up to 22 days of vacation, 10 recognized holidays, and sick time.
• Competitive health insurance packages with priority appointments and lower copays/coinsurance.
• Take advantage of our free Metro transit U-Pass for eligible employees.
• WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.
• Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
• We offer 4 weeks of caregiver leave to bond with your new child.
• Family care resources are also available for your continued childcare needs.
• Need adult care? We’ve got you covered.
• WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees