Clinical Research Coordinator II - Center for Outcomes REsearch in Surgery (CORES)

Children’s Hospital of Philadelphia•Philadelphia, PA

About The Position

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. The center for Outcomes REsearch in Surgery (CORES) was established in 2023. CORES’s mission is to improve outcomes for children with diseases that require surgical intervention. CORES has created an infrastructure to support a wide breadth of patient-centered outcomes research (PCOR) in the Department of Surgery, including clinical trials, comparative effectiveness research, implementation science, and qualitative research. PCOR, which transcends clinical specialty, is the embodiment of the tenets for the culture of the DOS at CHOP: starting with the patient, building relationships, and goal-directed improvement. The CRC II will assist and support the study teams in the Department of Surgery on their research and/or outcomes improvement projects, with responsibilities including but not limited to participant recruitment, data collection, patient follow up, IRB submission.

Requirements

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

Nice To Haves

Previous engagement in clinical research and experience with electronic health records and REDCap
Previous engagement in participant recruitment (screening, consenting, patient follow up, etc.)
High organizational skills
Strong communication skills with various types of patients
Familiarity with IRB protocol submission
Familiarity with Microsoft Office
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