Clinical Research Coordinator I

Job Summary

This is a full-time research coordinator position that will support Dr. Senbagam Virudachalam’s research projects at the Children’s Hospital of Philadelphia. Dr. Virudachalam is a primary care physician and her research focuses on food justice, advancing equity in diet quality and health outcomes for all children. The primary project involves working with food-insecure families to promote fruit and vegetable consumption through vouchers and a food literacy and cooking skills intervention. The goal of this pilot is to empower low-income families to achieve improved fruit and vegetable intake.

The ideal candidate would have a Master’s Degree in Public Health, Nutrition, or related field and would be responsible for the coordination of all clinical research activities within the scope of Dr. Virudachalam’s clinical research protocols. These activities may include:

• Confirmation of subject eligibility, completion of case report forms, data clarification and entry in REDCap, assisting participants with survey completion

• Coordination of clinical research activities conducted within the CHOP healthcare network

• Training and supervision of junior staff

• Ongoing review of study procedures and management of participant flow

• Maintaining regular communication with study participants

• Planning and leading/facilitating virtual cooking sessions

• Packaging and shipping urine collection supplies to participants; maintaining inventory

• Coordination of the collection and acquisition of urine samples from participants

• Abstracting and coding data

• Initiating and maintaining communication with the principal investigator(s) and sponsor(s) on the status of active projects, patient care issues and protocol performance.

Additional core responsibilities are listed below.

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

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