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Clinical Research Coordinator I

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A Brief Overview
About the Department:

The Clinical Research Coordinator I (CRC) will work in the Craig-Dalsimer Division of Adolescent Medicine at the Children’s Hospital of Philadelphia (CHOP) and PolicyLab in the Research Institute. The mission of PolicyLab, a center of emphasis, at CHOP is to achieve optimal child health and well-being by informing program and policy changes through interdisciplinary research. The Children’s Hospital of Philadelphia Research Institute is an interdisciplinary institution dedicated to conducting basic, clinical and translational research on conditions and diseases that affect children, and it is part of the Children's Hospital of Philadelphia and University of Pennsylvania research community.

The CRC will work on HIV prevention and treatment research as well as the Gender and Sexuality Development Program’s (GSDP) research and quality improvement portfolios. This position will work with members of the CHOP Adolescent Initiative and the Gender and Sexuality Development Program. The Adolescent Initiative is an integrated system of clinical care, education, and research for adolescents and young adults seeking HIV prevention and treatment services. The GSDP offers psychosocial and medical support for gender expansive and transgender children and youth up to age 21 and their families. The GSDP multidisciplinary team includes specialists in gender identity development from Social Work and Family Services, Adolescent Medicine, Endocrinology, and Behavioral Health.

Position Description:

The Clinical Research Coordinator I will be aiding the Research Team and Principal Investigator (Director of Adolescent HIV services and Co-Director of the GSDP) in the coordination of clinical, behavioral, policy and community-engaged research to improve health outcomes of adolescents and young adults.Under the direction of the Principal Investigator(s), Co-Investigators, and Research Manager, the clinical research coordinator will be given various research duties for multiple research and quality improvement projects.
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.
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