Clinical Research Coordinator II - NICU PeliCaN Study

Our take on this role

About this role

Recruit and enroll NICU families for PeliCaN, a study testing postpartum doula support for mothers of NICU infants. Work takes place in NICUs and remotely, with occasional travel between study sites and scheduling flexibility.

What could you bring from clinical work?

• Nurses: Explaining clinical procedures to patients and families could help you guide study participants through the informed consent process.
• Social workers: Your experience engaging families and assessing their needs may help with screening and recruiting NICU families for the study.
• OTs: Coordinating care activities with clinical teams could help you organize study visits and follow-up care.
• PTs: Experience following clinical procedures and documenting care may help you follow the approved study protocol and maintain study records.
• SLPs: If you've explained complex information to families and checked understanding, that experience could help you explain the study protocol and intervention.

Full job description from Children's Hospital of Philadelphia

SHIFT:
Day (United States of America)

Seeking Breakthrough Makers Children’s Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care—and your career. CHOP does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means. 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

SALARY RANGE:

$58,300.00 - $72,900.00 Annually
Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.