Clinical Research Coordinator- Birth Defects Biorepository (BDB)

SHIFT:

Day (United States of America)

Clinical Research Coordinator I

Seeking Breakthrough Makers

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.

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A Brief Overview

The Birth Defects Biorepository (BDB) at The Children's Hospital of Philadelphia is a joint effort established by the Center for Fetal Diagnosis and Treatment and the Department of Surgery. Its primary purpose is to provide a mechanism to store and permit access to biological specimens and longitudinal participant clinical and research data to support and enhance the conduct of future research on children with birth defects. This unique and robust resource focuses on the maternal-fetal relationship, provides whole genome sequencing of family trios, and collects research-ready data both during fetal development and longitudinally after birth. The Clinical Research Coordinator (CRC) will work closely with a team of coordinators, genetic counselors, data abstractionists, and data analysts. The CRC will primarily be responsible for consenting subjects, manual review of the medical record, and data entry. The CRC will also be responsible for managing biological specimens. Specimen management includes transport, labeling, and minimal processing of tissue samples collected in the OR.

What you will do

• 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
• 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
• Related responsibilities
• 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

Education Qualifications

• High School Diploma / GED - Required
• Bachelor's Degree - Preferred

Experience Qualifications

• At least two (2) years of clinical or research related experience - Required
• At least three (3) years of clinical or research related experience - Preferred

Skills and Abilities

• 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

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more.

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SALARY RANGE:

$51,730.00 - $64,660.00 Annually

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.