Clinical Research Coordinator II - Pediatric Neonatology

Summary

The Clinical Research Coordinator II will support a multi‑year NIH‑funded R01 study in the Department of Pediatrics, Section of Neonatology. This position plays a central role in recruiting premature infants with chronic lung disease and their parents, administering study questionnaires, coordinating remote (text or email) follow‑up through early childhood, and serving as the primary liaison for 14 collaborating study sites. At least three days per week of in‑person work is required during the first year to support recruitment and enrollment activities in the neonatal intensive care unit (NICU). After the first year, more flexible hybrid work arrangements may be accommodated.

Primary Responsibilities

Participant Recruitment & Enrollment

• Recruit, screen, enroll, and obtain consent from premature infants with chronic lung disease and their parents during the weeks prior to NICU discharge at Children’s Wisconsin.
• Administer electronic questionnaires related to infant health and parent caregiving experiences.

Study Coordination & Protocol Management

• Coordinate all aspects of the research protocol, including scheduling and tracking follow‑up questionnaires sent via REDCap through email or text from discharge through 18–24 months of age.
• Maintain ongoing communication with study participants and ensure timely completion of remote assessments.
• Coordinate electronic health record review for enrolled participants throughout the follow‑up period.

Multi‑Site Coordination

• Serve as the primary point of contact for 14 partnering study sites conducting parallel recruitment, enrollment, and follow‑up.
• Work collaboratively with site PIs, the study PI, and the REDCap team to ensure adherence to study protocols and consistent data collection across all centers.

Data Management & Reporting

• Collect, organize, and maintain study data in REDCap and associated databases.
• Work with the PI and biostatistical team to prepare progress reports for the study monitoring board and IRB.
• Assist with quarterly reporting and coordination of site payments in collaboration with the PI and grants office.

Regulatory Compliance

• Ensure compliance with all IRB and regulatory requirements.
• Prepare IRB submissions, amendments, and continuing reviews.
• Contribute to the evaluation and writing of research protocols in collaboration with the PI.

Program Materials & Communication

• Assist in developing study materials, including participant communications, forms, and reports.
• Track study timelines and ensure deadlines for all components are met.
• Organize internal and external meetings, site visits, and study‑related events.

Budget & Resource Support

• Monitor study‑related budgets and assist with financial coordination across sites.
• Support development of program resources through literature searches and communication with collaborating programs.
• Other duties as assigned.

Knowledge – Skills – Abilities

• Knowledge of clinical research processes, documentation, and records management including IRB.
• Strong data management skills, including use of REDCap.
• Excellent critical thinking, problem‑solving, and communication skills.
• Ability to work effectively with clinical teams in an intensive care environment and communicate sensitively with families of infants with significant health needs.
• Proficiency with word‑processing and spreadsheet software for report preparation and documentation.

Qualifications

Appropriate experience may be substituted for education an on equivalent basis.

Minimum Required Education:

• Bachelor’s degree

Minimum Required Experience:

• 2 years of relevant clinical research experience

Preferred Experience:

• Experience with prospective or multi-site studies preferred

Why MCW?

• Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options

• 403B Retirement Package

• Competitive Vacation and Paid Holidays offered

• Tuition Reimbursement

• Paid Parental Leave

• Employee & Family Assistance Program (EFAP)

• Pet Insurance

• On campus Fitness Facility, offering onsite classes

• Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.

For a brief overview of our benefits see: Benefits Overview

For a full list of positions see: MCW Careers

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The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.