Clinical Research Coordinator - Autism Research

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. Under moderate supervision from study PI or other research study management staff, coordinates all clinical research activities within the scope of clinical research protocols. As part of the hospital’s Omics and Big Data efforts and the Lurie Autism Center, the Children’s Hospital of Philadelphia is hiring a research team member to support activities of the institutional-wide biobank in the Lurie Autism Center. This role will help with various aspects of research processes including patient recruitment, enrollment, and documentation, and biospecimen collection and recording. The role will be involved in instituting innovative ways to educate families and obtain consent for research. This position reports to the CHOP Biobank Manager.

Requirements

High School Diploma / GED Required
At least two (2) years of clinical or research related experience Required
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

Nice To Haves

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