Clinical Research Coordinator II - NICU PeliCaN Study

Children’s Hospital of Philadelphia (CHOP) is conducting the PeliCaN multi-site clinical trial on postpartum doula support for mothers of NICU infants. The Clinical Research Coordinator II recruits and enrolls participants, obtains informed consent, collects and enters study data, and coordinates with study doulas and NICU staff.

Tags

Health Care

Family & Care

Healthcare

Hospital

Non Profit

Child Care

Medical

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Alex Stevens & 4 connections

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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

Preferred

Master's Degree in a related field Preferred

At least three (3) years of clinical/research coordination experience Preferred

Benefits

Work directly in NICU settings and remotely

Glassdoor

3.9

Since its start in 1855 as the nation's first hospital devoted exclusively to caring for children, The Children's Hospital of Philadelphia has been the birthplace for many dramatic firsts in pediatric medicine.

Philadelphia, Pennsylvania, USA

http://chop.edu

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Management and Executive

Arts and Entertainment

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(94)

2025

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2022

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2020

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Qualifications

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

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

Master's Degree in a related field Preferred

At least three (3) years of clinical/research coordination experience Preferred

Required skills

Represents the skills you have, click on the tags, IRB and Human Subject Protection, Stakeholder Collaboration

Preferred skills

Master's Degree in a related field Preferred

Experience

2+ years