Clinical Research Coordinator I

Job Summary

The successful candidate will join the research teams of Dr. Laura Vella and Dr. Brian Fisher in the Pediatric IDEAS Research Group at Children’s Hospital of Philadelphia. Dr. Vella’s research is translational and focuses on vaccine responses in settings of immune health and immune compromise. Dr. Fisher's research focuses on infections in children with immunocompromising conditions.

The applicant is expected to work comfortably as part of a research team. The successful applicant should have strong writing, organizational, and analytical skills. A collaborative working style is required. The successful applicant will be responsible for leading specific projects. The candidate will be a member of the Pediatric IDEAS Research Group, a collaborative group of investigators within the Center for Pediatric Clinical Effectiveness (CPCE) at CHOP. The mission of the Pediatric IDEAS Research Group is to perform rigorous clinical and translational research that generates evidence on the prevention and treatment.

Job Responsibilities

Core 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

Related responsibilities

Manage essential regulatory documents Register study on ClinicalTrial.gov

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 Facilitate study close out activities

Coordinate research/project team meetings Collect, process and ship laboratory specimens Schedule subject visits and procedures

Retain records/archive documents after study close out

Required Education and Experience

Required Education:

Associates Degree or active enrollment in a Bachelor’s Degree Program

Required Experience:

Three (3) years of coordination related, clinical related or research related experience.

Preferred Education, Experience & Cert/Lic

Preferred Education: Bachelor’s Degree in related field

Additional Technical Requirements

Excellent verbal and written communications skills Excellent time management skills

Ability to collaborate with stakeholders at all levels

To apply, please submit a resume and cover letter to Shawn O'Connor, oconnors1@chop.edu.