CRSO IND IDE Specialist

Company Name: Childrens Hospital of Philadelphia

Location: Philadelphia, PA, US - 19104

Job Duration: 2022-01-14 to 2022-02-13

Overview

Location: LOC_HOME-Home/Remote Office Location 

Req ID: 162433

Shift: Days

Employment Status: Regular – Full Time 

About Us

We’re seeking breakthrough makers! Children’s Hospital of Philadelphia was built on the belief that we can change lives. Today, in every role throughout our hospital, research institute and care network, the 22,000 members of our workforce are finding new ways – big and small – to make a difference for the patients and families we serve.

If you are ready to challenge yourself, be inspired and grow – no matter what your role – you just may be the kind of breakthrough maker who will thrive at CHOP.

Job Summary

The CRSO IND/IDE Specialist, with the oversight of the Directors of Clinical Research and the Clinical Research Support Office (CRSO) provides administrative support and investigator guidance for the CRSO’s IND/IDE program. The CRSO IND/IDE Specialist develop and maintain all operational functions that support IND/IDE activities at The Children’s Hospital of Philadelphia (CHOP). These operational functions include IND/IDE consultation; regulatory support; training and education; development of IND/IDE-related policies, procedures, guidances, templates, tools; maintenance of the program’s intranet site; and administrative support to the IND/IDE scientific review committee (SRC). Develops and reports upon performance metrics for the program.

Job Responsibilities

  • Reviews, develops and submits regulatory applications to FDA as needed to support sponsor-investigator INDs and IDEs at CHOP including but not limited to pre-INDs, initial INDs and IDEs, amendments, supplements, safety reports and annual reports

  • Provides guidance to sponsor-investigators and study teams in the development of their submissions to FDA,

  • Reviews essential documents as needed for regulatory submission including but not limited to initial and amended protocols and any FDA required forms

  • Maintains trial master files for INDs and IDEs sponsored by the CHOP Research Institute and conducts QA audits of files on an on-going basis

  • Serves as liaison with the FDA as appropriate; assists will scheduling, coordinating, preparing, and attending FDA meetings; responsible for the preparation and oversight of FDA audits

  • Develops, reviews, and maintains of the program’s policies and procedures

  • Develops, reviews, and maintains templates, tools, and guidance documents needed for the function of the program

  • Collaborates with investigators to develop sponsor-investigator SOPs and monitoring plans

  • Manages non-program-specific regulatory projects as requested by the Director, CRSO

  • Assists monitoring team and provides review of on-going monitoring reports as needed

  • Assists with internal and external audits; prepares corrective actions, if necessary

  • Administratively coordinates the IND-IDE Scientific Review Committee by scheduling meetings, creating agendas, developing meeting minutes, and other administrative support activities as needed

  • Maintains current knowledge of regulatory environment especially changes to regulations and guidance documents that are applicable to sponsor-investigator research at CHOP

  • Creates and delivers IND-IDE workshops, presentations, and other educational materials and opportunities; leverages external training to benefit the program and research activities at CHOP; ensures program’s objectives are effectively communicated to appropriate stakeholders

  • Maintains the program’s intranet site

  • Participates in long-range planning of the program’s activities

  • Operates the program within the budgetary parameters and provides recommendations for budget planning; projects expenditures; drafts financial reports

  • Supports the CRSO’s cost-recovery mission by seeking opportunities to cost-recover the activities of the program as appropriate

  • Performs functions that ensure compliance with institutional policies, state and federal regulations, and requirements of funding agencies

  • Performs other related duties as assigned

Job Responsibilities (Continued)

Job Responsibilities (Continued)

Required Licenses, Certifications, Registrations

Required Education and Experience

Required Education: Bachelor’s degree

 

Required Experience: Minimum three (3) years of relevant experience in a clinical research regulatory environment, specifically IND-IDE research.

Preferred Education, Experience & Cert/Lic

Preferred Experience: Experience and functional knowledge of FDA regulations specifically IND and IDE regulations

 

Preferred Licenses/certificates/registrations: Regulatory Affairs Certification (RAC)

Additional Technical Requirements

  • Demonstrated ability to work independently and drive processes

  • Demonstrated ability to manage projects

  • Excellent writing skills; experience in policy and SOP development

  • Ability to work with individuals from all levels within the organization

  • Working knowledge of 21 CFR 312 and 812

  • Current knowledge of human subject protection and GCP regulations including by not limited to 21 CFR 11, 50, 54, 56, 312, 812, and 45CFR46

  • Prefer experience in interpretation and application of IND and IDE regulations in unique environment

  • Prefer some knowledge/experience working with GLP and GMP environment

  • Prefer experience in regulatory writing- regulatory submission work

  • Excellent analytical skills

  • Strong computer skills in a windows environment, including Microsoft Word, Excel and good editing and proofing skills

  • Excellent communication, interpersonal and creative problem solving skills.

  • Ability to gain knowledge of hospital systems (EPIC, Chartmax, SCM, etc)

To carry out its mission, it is of critical importance for the Children’s Hospital of Philadelphia (CHOP) to keep our patients, families and workforce safe and healthy and to support the health of our global community. In keeping with this, CHOP has mandated all workforce members on site at any CHOP location for any portion of their time be vaccinated for COVID-19. This mandate also applies to workforce members performing work for CHOP at non-CHOP locations. The CHOP COVID-19 vaccine mandate is in alignment with applicable local, state and federal mandates.

CHOP also requires all workforce members who work in patient care buildings or who provide patient care to receive an annual influenza vaccine. Employees may request exemption consideration for CHOP vaccine requirements for valid religious and medical reasons.

Please note start dates may be delayed until candidates are fully immunized or valid exemption requests are reviewed. In addition, candidates other than those in positions with regularly scheduled hours in New Jersey, must attest to not using tobacco products.

EEO / VEVRAA Federal Contractor