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REGULATORY AFFAIRS COORDINATOR

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Posting Details

Posting Details

Reference Number 40-26900
Posted Job Title REGULATORY AFFAIRS COORDINATOR
School Name Perelman School of Medicine
Org CC-Cancer Center
Posted to the Web 09/28/2017
Posted Job/Salary Grade 026/027
Employment Type Exempt
Hours N/A
Position Type Full Time
Position Schedule 8:00am-5:00pm
Months 12
Position Length Contingent Upon Funding
Position End Date
University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

School/Center Overview

The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/

Duties

Regulatory Affairs Coordinator B: With minimal supervision, participate in the coordination of Phase I-IV clinical trials. Prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events and reportable events. Prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA. Organize and maintain all regulatory affairs documentation/files as required. Resolve regulatory and data queries as required. Participate in initiation, monitoring, audit and close-out visits. Participate in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings. Assist in the development of investigator-initiated research protocols, assist with FDA IND applications and annual reports, and assist in the development/maintenance of study specific case report forms and source document tools. Assist with regulatory/compliance guidance/oversight of investigator initiated trials and investigator-initiated multi-site trials. Support compliance and quality assurance activities within the ACC CRU.

Regulatory Affairs Coordinator C: Independently participate in the coordination of Phase I-V clinical trials. Prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events. Prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA. Organize and maintain all regulatory affairs documentation/files as required. Resolve regulatory and data queries as required. Participate in initiation, monitoring, audit and close-out visits. Participate in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings. Oversee the development of investigator-initiated research protocols, the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools. Provide direct regulatory/compliance guidance and oversight of investigator initiated trials and investigator-initiated multi-site trials. Oversee compliance and quality assurance activities within the ACC CRU.

Qualifications

Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations.

Regulatory Affairs Coordinator B: Bachelor’s degree and 2-4 years of related experience, or equivalent combination of education and experience, are required.

Regulatory Affairs Coordinator C: Bachelor’s degree and 4-6 years of related experience, or equivalent combination of education and experience, are required.

Affirmative Action Statement

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements
Quick Link http://jobs.hr.upenn.edu/postings/31598

Posting Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this employment opportunity?
    • Jobs@Penn
    • Contacted by a Penn Recruiter
    • Referred by a Penn Employee
    • Referred by a friend or family member
    • Higher Education Recruitment Consortium (HERC)
    • Inside Higher Ed
    • Indeed.com
    • Other Internet Advertisement
    • Linkedin
    • Twitter
    • Other Social Media Site
    • Professional Affiliation/Trade Website
    • Diversity Association/Publication Website
    • Heard about it at a conference or career fair
    • Apple One
    • Recruitment and/or staffing agency
  2. * What is your highest level of education completed?
    • Less than high school education
    • High School Diploma or GED
    • Vocational or Technical School
    • Associate's Degree or Two Year College
    • Bachelor's Degree
    • Master's Degree
    • PHD/MD/JD or equivalent doctoral degree
  3. * How many years of experience do you have related to this position?
    • 0 to 1 Year
    • 1 to 2 Years
    • 2 to 3 Years
    • 3 to 5 Years
    • 5 to 7 Years
    • 7 to 10 Years
    • Over 10 Years

Applicant Documents

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter