Reference #: 1010560
SHIFT:Day (United States of America)Seeking Breakthrough MakersChildren'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 InclusionCHOP 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
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.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 outEducation Qualifications
High School Diploma / GED Required
Bachelor's Degree PreferredExperience 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 PreferredSkills 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 levelsTo 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 Contr ctor | Tobacco StatementChildren'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.