Skip to Main Content

CLIN RESEARCH REGULATORY COMPLIANCE SPECIALIST SR.

Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click the Apply for this Job link/button.

If you would like to bookmark this position for later review, click on the Bookmark link. If you would like to print a copy of this position for your records, click on the Print Preview link.

Posting Details

Posting Details

Reference Number 40-27356
Posted Job Title CLIN RESEARCH REGULATORY COMPLIANCE SPECIALIST SR.
School Name Perelman School of Medicine
Org SM-DN-Office of Clinical Research
Posted to the Web 11/17/2017
Posted Job/Salary Grade 028
Employment Type Exempt
Hours N/A
Position Type Full Time
Position Schedule 8:30-5:30
Months 12
Position Length Ongoing
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

The Senior Clinical Research Compliance Specialist is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine and reports directly to the Director of Compliance of the OCR. Under the management of the Director of Compliance, this position will plan, schedule and conduct regulatory compliance reviews of Penn Faculty and University held IND/IDE’s and international regulatory filings. Compliance Reviews will focus on all aspects of clinical research execution to ensure activities are in compliance with applicable federal, international and local regulations, and established University of Pennsylvania policies and procedures.
This position will interface with the Perelman School of Medicine faculty and staff, institutional offices, clinical departments and research institutes. Within the OCR, the Senior Clinical Research Compliance Specialist will interface with other OCR Divisions to ensure the best support of research regulatory requirements, to assist with OCR research educational initiatives and to participate in research staff training. The candidate is also responsible for mentoring junior staff members within the compliance team.

Qualifications

A Bachelor’s degree and 5 to 7 years of experience, or an equivalent combination of education and experience, are required. Degree in biomedical science, nursing or related health science is preferred. Master’s Degree in advanced science is preferred; a minimum of 3-5 years of work experience in compliance oversight of clinical trials (monitoring, QA or auditing), study coordinator, project management, or combination thereof in any of the following environments: Academia, Pharmaceutical Industry, Contract Research Organizations (academic or private sector) or Site Management Organization (academic or private) required; an in-depth knowledge of and experience in the application of Good Clinical Practice (GCP) requirements is required (e.g., ICH, FDA, etc.). Familiarity with the essential documents related to clinical studies, medical terminology and routine medical tests and procedures preferred; familiarity with computerized clinical data collection systems and biomedical statistics is preferred; familiarity with Good Manufacturing Practices preferred; advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines; ability to respect and protect highly sensitive and confidential information.

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/32934

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