Clinical Research Quality Specialist B

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.

As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023.

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.

Clinical Research Quality Specialist B

Clinical Research Quality Specialist B

Supports clinical research and compliance by partnering with senior team members to conduct reviews, including preparation, implementation, closeout and reporting to ensure adherence to federal regulations and institutional policies. Interfaces with investigators, project managers, sponsors and staff during the review process. Will also lead in the development of consent forms, case report forms, checklists and other study documentation. Will mentor junior staff on good clinical practices in research.

• Assist in the facilitation and conduct of compliance reviews for sponsor and investigators, including preparation, reporting and close-out

• Provide support to investigators and research staff in the development of protocols, informed consent forms, case report forms and other related study documentation

• Conduct training of investigators, sponsors and clinical research staff in areas related to clinical research

• Assist with regulatory submissions and maintenance of documentation

• Partnering with data analytics to develop reports

• Performs additional duties as assigned.

• CONTINGENT UPON FUNDING

• Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required

Philadelphia, Pennsylvania

Perelman School of Medicine

$62,000.00 - $72,500.00 Annual Rate

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics) , citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

• Health, Life, and Flexible Spending Accounts
  :
  Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.

• Tuition
  :
  Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here r dependent children are also eligible for tuition assistance at other institutions.

• Retirement
  :
  Penn offers generous retirement plans to help you save for your future. Penn’s…