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Research Regulatory Coordinator

Philadelphia, PA, US, 19104

Job Type: 

Req ID: 24048

Shift: Days

Employment Status: AF - Active - Regular - Full Time 

Job Summary

The Clinical Research Support Office (CRSO) is the central office for clinical research support services at CHOP. The CRSO provides leadership, administrative guidance, and support services to support clinical investigators with investigator-initiated and industry-sponsored research projects. The mission of the CRSO is to make it easier for the CHOP research community to conduct quality clinical research projects.

As part of the CRSO, the Clinical Trial Support program provides guidance to study teams with administrative aspects of study start-up and management and connects study teams with clinical trial tools and services provided at CHOP. Clinical Trial Support is also responsible for the administration of the OnCore Clinical Trial Management System at CHOP. As part of a dedicated team focused on study start-up, the Regulatory Coordinator will onboard studies quickly and effectively. The Regulatory Coordinator will also work closely with the IND/IDE Support Program to assist sponsor-investigator teams with FDA and IRB submissions.          

More information on the CRSO below:      

https://crso.research.chop.edu/                                                                                                                                                   

Job Responsibilities

The Regulatory Coordinator is responsible for any of the following:

  • Applies in depth knowledge of clinical research and independently coordinates the start-up activities of multiple studies including IRB, contract, and budget submissions
  • Monitors overall study start-up processes with a focus on expediting timelines
  • Provides resources and consulting on protocols or projects for study teams
  • Independent of the PI, assesses and critiques protocol feasibility and provides recommendations
  • Reviews Informed Consent Forms for consistency with contract and budget terms
  • Assists IND/IDE sponsor-investigator teams with IRB start-up submissions
  • Assists IND/IDE sponsor-investigator teams with initial and ongoing FDA submissions
  • Tracks FDA submission deadlines for sponsor-investigator INDs/IDEs
  • Maintains IND/IDE Support Program Intranet page 
  • Schedules sponsor-investigator trainings and maintains training database
  • Assists the Recruitment Enhancement Core (REC) by evaluating the recruitment plan in the protocol and connect the study team with appropriate REC resources to help with feasibility and enrollment
  • Complies with institutional policies, standard operating procedures (SOPs) and guidelines
  • Complies with federal, state, and sponsor policies
  • Other duties as assigned

                                                                                                                                                               

Required Licenses, Certifications, Registrations

Required Education and Experience

Bachelor’s Degree with minimum 2-3 years clinical research experience or a Masters Degree in a relevant field with minimum 1 year clinical research experience

Preferred Education, Experience & Cert/Lic

Preferred Education: MA/MS in a related field

 

Preferred Experience:

2+ year(s) relevant clinical research coordination experience

Completion of requisite Good Clinical Practice (GCP) training

Society of Clinical Research Associates – SoCRA membership or Association of Clinical Research Professionals – ACRP membership

Additional Technical Requirements

Specific knowledge and skills:

  • 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

 

 

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