Clinical Research Coordinator II - NICU PeliCaN Study

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Day (United States of America)

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A Brief Overview

Researchers at the Children's Hospital of Philadelphia (CHOP) are conducting

PeliCaN (Postpartum Care in the NICU), a first-of-its-kind, NIH-funded (R01) multi-site randomized controlled clinical trial testing whether postpartum doulas embedded directly in the NICU can improve postpartum health and healthcare for mothers of NICU infants. NICU mothers are 3 to 4 times more likely to develop postpartum depression and nearly 3 times more likely to experience hypertensive disorders of pregnancy than mothers of well infants.

Yet, the demands of having a critically ill newborn often make it difficult to attend to their own postpartum care and address their own health needs. PeliCaN Multi-Site aims to enroll up to 900 mothers across 12 NICUs in the CHOP Newborn Care Network to test the effectiveness and feasibility of postpartum doula support for improving postpartum health and healthcare equity among NICU families.

We are seeking a dedicated and compassionate Clinical Research Coordinator II (CRC) to join the PeliCaN Multi-Site team. The PeliCaN CRC will work closely with the core study team, including the PI (Dr. Heather Burris), study manager (Dr. Katey Mari), and our lead doulas (Niesha Darden and Laura Walker).

In this role, you will work directly in NICU settings and remotely to recruit eligible families, obtain informed consent, enroll study participants, collect and enter study data in REDCap, and partner closely with study doulas to coordinate support for intervention participants. The ideal candidate is highly organized and motivated, with strong communication and time management skills, and thrives in a team environment.

The PeliCaN CRC should possess the ability to manage recruitment across multiple hospitals while balancing enrollment targets and adapting to clinical workflows, as well as collaborating with a range of NICU staff members. This role requires occasional travel between study sites and scheduling flexibility.

What you will do

• Core responsibilities
• Adhere to an IRB approved protocol
• Participate in the informed consent process of study subjects
• Support the safety of clinical research patients/research participants
• Coordinate protocol related research procedures, study visits, and follow-up care
• Screen, recruit and enroll patients/research participants
• Maintain study source documents
• Report adverse events
• Understand good clinical practice (GCP) and regulatory compliance
• Educate subjects and family on protocol, study intervention, etc.
• Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
• Must comply with federal, state, and sponsor policies
• Related responsibilities
• Prepare, manage, submit, and maintain essential regulatory documents (e.g. IRB, FDA, etc.) and remain aware of the regulatory status for projects within scope of role
• Register study on ClinicalTrial.gov as appropriate
• Complete case report forms (paper & electronic data capture) and address queries
• Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate
• Facilitate study close out activities as appropriate
• Coordinate research/project team meetings
• Collect, process and ship laboratory specimens
• Schedule subject visits and procedures
• Retain records/archive documents after study close out
• Additional Responsibilities may include
• Manage study finances including sponsor invoicing & resolving study subject billing issues
• Develop advertisement materials
• Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
• Organize and/or run study-related meetings locally or across teams (for multi-site projects)
• Support study team communications and outreach
• Provide training to junior staff on conduct of research studies
• Document investigational product (drug/device) accountability
• Self-monitor and self-audit responsibilities
• Develop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manuals
• Maintain Clinical Trial.gov
• Develop Case Report Forms
• Assignments to include more complex studies
• Education Qualifications
• Bachelor's Degree Required
• Master's Degree in a related field Preferred
• Experience Qualifications
• At least two (2) years of clinical/research coordination experience Required
• At least three (3) years of clinical/research coordination experience Preferred
• Skills and Abilities
• Basic knowledge of IRB and human subject protection
• Excellent verbal and written communications skills
• Strong time management skills
• Ability to collaborate with stakeholders at all levels
• To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more.
• EEO / VEVRAA Federal Contractor | Tobacco Statement