Clinical Research Coordinator - Epilepsy

Reference #: 1010781

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 Con ractor | 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.