Job Information
The Children's Hospital of Philadelphia Clinical Research Coordinator - Division of Neurosurgery in Philadelphia, Pennsylvania
Reference #: 1008724 SHIFT:Day (United States of America)
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A Brief Overview Under moderate supervision from study PI or other research study management staff, this role provides substantial coordination level support for all clinical research activities within the scope of clinical research protocols.
About the Department We are seeking a dedicated Research Associate to join our Clinical Outcomes Follow-up Program, with a specific focus on patients who are treated by Pediatric and Fetal Neurosurgeons. This role involves engaging in groundbreaking research that aims to improve the long-term health outcomes for patients born with congenital anomalies, including those requiring fetal surgery for Myelomeningocele (MMC).
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. s 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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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.