Clinical Research Coordinator II - NICU PeliCaN Study

Children's Hospital of Philadelphia•Philadelphia, PA

1d•$58,300 - $72,900•Hybrid

About The Position

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.

Requirements

Bachelor's Degree Required
At least two (2) years of clinical/research coordination experience Required
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

Nice To Haves

Master's Degree in a related field Preferred
At least three (3) years of clinical/research coordination experience Preferred

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
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
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