Clinical Research Coordinator - Neurofibromatosis and Neuro-Oncology at Children’s Hospital of Philadelphia

Philadelphia, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Feb, 26

Salary

71110.0

Posted On

22 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research Coordination, Informed Consent Process, Patient Safety, Protocol Coordination, Patient Recruitment, Regulatory Compliance, Good Clinical Practice, Communication Skills, Time Management, Team Collaboration, Adverse Event Reporting, Data Management, Laboratory Specimen Handling, Financial Management, Training, Document Management

Industry

research

Description

SHIFT: Day (United States of America) Clinical Research Coordinator II 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 does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means. A Brief Overview Children's Hospital of Philadelphia is hiring in Neuro-Oncology, a sub-section of Oncology. The Neuro-Oncology team is under the direction of Dr. Michael Fisher, who also serves as the Director of the Neurofibromatosis Clinical Trials Consortium (NFCTC). Dr. Cassie Kline is the Director of Clinical Research for Neuro-Oncology, and also serves as the Director of Data Quality and Integration of the Pediatric Neuro-Oncology Consortium (PNOC). We currently have over 50 ongoing clinical trials, in different phases, that cover an array of tumors that affect the central nervous system (CNS). Our Principal Investigators (Pl) are dedicated to improve the survival outcomes, quality of life, and care of children and young adults with CNS tumors. The Pis are joined with a team of clinical research coordinators, study nurses, nurse practitioners, and other ancillary team members. Our group aims to grow novel clinical trials within the Children's Hospital of Philadelphia, but we are also active members of neuro-oncology clinical research consortia, such as NFCTC and PNOC, and collaborate broadly with institutions through the US and internationally. 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 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 Must comply with federal, state, and sponsor policies Related responsibilities Prepare, manage, submit, and maintain essential regulatory documents (e.g. IRB, FDA, etc.) and remain aware of the regulatory status for projects within scope of role Register study on ClinicalTrial.gov as appropriate Complete case report forms (paper & electronic data capture) and address queries 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 laboratory specimens Schedule subject visits and procedures Retain records/archive documents after study close out Additional Responsibilities may include Manage study finances including sponsor invoicing & resolving study subject billing issues Develop advertisement materials Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals Organize and/or run study-related meetings locally or across teams (for multi-site projects) Support study team communications and outreach Provide training to junior staff on conduct of research studies Document investigational product (drug/device) accountability Self-monitor and self-audit responsibilities Develop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manuals Maintain Clinical Trial.gov Develop Case Report Forms Assignments to include more complex studies Education Qualifications Bachelor's Degree Required Master's Degree in a related field Preferred Experience Qualifications At least two (2) years of clinical/research coordination experience Required At least three (3) years of clinical/research coordination experience Preferred Skills and Abilities Basic knowledge of IRB and human subject protection Excellent 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 receive an annual influenza vaccine. Learn more. EEO / VEVRAA Federal Contractor | Tobacco Statement SALARY RANGE: $56,890.00 - $71,110.00 Annually Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly. ------------------- At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.

Responsibilities

The Clinical Research Coordinator will adhere to IRB approved protocols and participate in the informed consent process for study subjects. They will coordinate protocol-related research procedures, screen and enroll patients, and maintain study documentation.