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Clinical Research Coordinator II - Neuro-Oncology and Neurofibromatosis

Children's Hospital of Philadelphia · Philadelphia, PA · 1 wk ago
Analyst$58k–$73k/yrFull-time

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.

About the role

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 affecting the central nervous system (CNS). Our Principal Investigators (PIs) are dedicated to improving the survival outcomes, quality of life, and care of children and young adults with CNS tumors. The PIs work 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 CHOP and is also active in neuro-oncology clinical research consortia such as NFCTC and PNOC, collaborating broadly with institutions across the U.S. and internationally.

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

Additional Responsibilities

  • Prepare, manage, submit, and maintain essential regulatory documents (e.g., IRB, FDA) and remain aware of the regulatory status for projects within scope of role
  • Register study on ClinicalTrials.gov as appropriate
  • Complete case report forms (paper & electronic data capture) and address queries
  • Facilitate pre-study, site qualification, study initiation, and monitoring visits 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
  • 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 documents and/or draft or edit IRB protocols or related documents such as study administration manuals
  • Maintain ClinicalTrials.gov
  • Develop Case Report Forms
  • Assignments to include more complex studies

Requirements

  • Bachelor's Degree (Required)
  • Master's Degree in a related field (Preferred)

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

Pay

Salary range: $58,300.00 - $72,900.00 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.

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