University of Pennsylvania CLIN RES MONITORING SPEC in Philadelphia, Pennsylvania

CLIN RES MONITORING SPEC 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.

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Posting Details

Posting Details

Reference Number 40-29034

Posted Job Title CLIN RES MONITORING SPEC

School Name Perelman School of Medicine

Org SM-DN-Office of Clinical Research

Posted to the Web 06/11/2018

Posted Job/Salary Grade 027

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 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, PSOM Clinical Research Audit and Compliance. The Clinical Research Compliance Specialist will work as part of the Compliance team to help support and facilitate clinical research at the University of Pennsylvania. The Clinical Research Compliance Specialist will work with senior team members to facilitate and conduct high quality compliance reviews, which include review preparation, conduct, close out and reporting, to ensure compliance with federal regulations and institutional policies. This position will interface with research investigators and staff throughout the review process. In addition to compliance reviews, this position will assist in the development of protocols, informed consents, case report forms, and other study documentation for Principal Investigators as needed. Within the OCR, the Clinical Research Compliance Specialist will interface with other OCR units to ensure the best support of research regulatory requirements, to assist with OCR research educational initiatives and to participate in research staff training.

Qualifications

  • Bachelor’s degree and at least three to five years of work experience in clinical/translational research compliance and/or operations in any of the following areas: Academia, Pharmaceutical Company, Contract Research Organization (academic or private sector) or Site Management Organization (academic or private), on an equivalent combination of education and experience required* Experience in the following areas preferred:- Compliance oversight for clinical trials; monitoring or auditing of studies - Coordination of clinical research studies- 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/37625

Posting Supplemental Questions

Required fields are indicated with an asterisk (*).


  • 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


  • 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


  • 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

  • Resume

Optional Documents

  • Cover Letter