Clin Res Reg Coord - Per Diem:
CHOP

16602-en_US
CHOP
Philadelphia Pennsylvania
Healthcare
Description

Req ID: 16602

Shift: Days

Employment Status: AX - Active - Per Diem 

Job Summary

The Clinical Research Regulatory Coordinator assumes a central, key role for all studies conducted under the auspices of the Children’s Oncology Group research program and other assigned Oncology Division studies. This position will create and maintain site investigator/regulatory binders, submit correspondence to the relevant Institutional Review Boards and Pediatric Protocol Review Committee, track study approval and expiration dates,facilitate internal and external monitoring and auditing of site investigator/regulatory files and perform other duties as assigned. This position will serve as a central resource for Children’s Oncology Group study coordinators and other staff regarding all regulatory matters and may assist in the training of new employees.

 

Must be knowledgeable on, have full understanding of, and promote good clinical practices (GCP) and will be held accountable for adherence to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA,ICH, GCP, or other sources.

Job Responsibilities

This role will work with minimal supervision by a supervisor to:

  •  Create regulatory binders for new studies
  • Maintain regulatory binders, ensuring all relevant sections of binder are organized,complete and up to date 
  •  Submit new and amended studies to the Pediatric Protocol Review Committee
  • Submit regulatory correspondence to the relevant Institutional Review Boards,including new protocols, amendments, continuing reviews, serious adverse events,
  • safety reports, unanticipated problems and deviations; serve as the liaison for the Study PI regarding regulatory issues
  •  Track regulatory approvals and expiration dates of studies, communicate this information to the Study PI, Study Coordinator and other staff, and obtain all required information (including signatures, conflict of interest forms, etc.) from Study PI, Study Coordinator and other staff to ensure regulatory reviews occur in a timely manner
  • Create and update CHOP-specific consent forms, based on templates provided. Ensure all required language from sponsor and relevant Institutional Review Boards is included
  •  Update protocol information in the Oncology Research Clinical Trial Management System
  •  Facilitate internal and external monitoring and auditing of regulatory files by the sponsor, CRO, CRQA, ACC, FDA or other entity; ensure regulatory binders are organized, complete and up to date prior to monitoring visit or audit

Required Licenses, Certifications, Registrations

Required Education and Experience

Required Education/Experience: Bachelor’s Degree with minimum 2-3 years clinical research experience OR a Master’s Degree in a relevant field with minimum 1 year clinical research experience. 

Preferred Education, Experience & Cert/Lic

Preferred Licenses/certificates/registrations: ACRP or SOCRA Certification

Additional Technical Requirements

  •  Computer competency including knowledge and proficiency in Microsoft Office Suite
  •  Strong organizational and time management skills
  •  Excellent written and verbal communication skills
  •  Flexibility/Adaptability in working in team environment
  •  Detail oriented
  •  Good follow through
  • Good Clinical Practices (GCP) knowledge preferred. Will be held accountable for adherence to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from ICH, IRB, FDA Regulations and other sources. Willingness to continue training related to Good Clinical Practices (GCP) and data related requirements and responsibilities.

All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.

Children's Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children's Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products or nicotine in any form and a negative nicotine screen (the latter occurs after a job offer).

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.

VEVRAA Federal Contractor/Seeking priority referrals for protected veterans.  Please contact our hiring official with any referrals or questions.

CHOP Careers Contact 

Talent Acquisition

2716 South Street, 6th Floor

Philadelphia, PA 19146 

Phone: 866-820-9288 

Email:TalentAcquisition@email.chop.edu

 

 

Basic Qualifications
Requirement