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Reference #: 1010749 SHIFT:Day (United States of America)

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.

CHOP's Commitment to Diversity, Equity, and Inclusion

CHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children.

We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.

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, manually 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 clinical related or research related experience Required At least three (3) years of clinical or clinical related 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 be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.

Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.

EEO / VEVRAA Federal Contractor |  Tobacco Statement

Children's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.