Clinical Research Coordinator I- ED

Children's Hospital of Philadelphia•Philadelphia, PA

19h•$51,730 - $64,660•Onsite

About The Position

Under moderate supervision from study PI or other research study management staff, this role provides substantial coordination level support for all clinical research activities within the scope of clinical research protocols. 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. Children's Hospital of Philadelphia (CHOP) is the nation's first hospital devoted exclusively to the care of children. Since our start in 1855, CHOP has been the birthplace for countless breakthroughs and dramatic firsts in pediatric medicine. Built on a foundation of delivering safe, high-quality, family-centered care, the Hospital has fostered medical discoveries and innovations that have improved pediatric healthcare and saved countless children’s lives. Today, families facing complex conditions come to CHOP from all over the world, and our compassionate care and innovation has repeatedly earned us a spot on the U.S. News & World Report's Honor Roll of the nation's best children's hospitals.

Requirements

High School Diploma / GED
At least two (2) years of clinical or research related experience
Basic knowledge of IRB and human subject protection
Strong verbal and written communications skills
Strong time management skills
Ability to collaborate with stakeholders at all levels
Receive an annual influenza vaccine (As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities)

Nice To Haves

Bachelor's Degree
At least three (3) years of clinical or research related experience

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
Under the supervision of PI 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, and with HIPAA and management of confidential materials
Comply with federal, state, and sponsor policies
For multi-site studies or collaborations, support communication and meeting scheduling across teams
Manage essential regulatory documents
Register study on ClinicalTrials.gov as appropriate
Complete case report forms (paper & electronic data capture) and address queries
Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie,DSMB, independent safety officer)
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 samples as applicable to the protocol
Schedule subject visits and procedures
Retain records/archive documents after study close out