Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.
The Mallinckrodt Institute of Radiology at Washington University is seeking to hire a Manager of Regulatory Support and Compliance to work in its Clinical Research Laboratory. The individual in this position will support clinical investigators and staff in radiology and in other Washington University School of Medicine departments in the submission of regulatory documents that involve imaging.
PRIMARY DUTIES AND RESPONSIBILITIES:
This includes submission of Food and Drug Administration (FDA) Investigational New Drug (IND) and Radioactive Drug Research Committee (RDRC) applications and progress reports, and ClinicalTrials.gov entry and maintenance.
A thorough understanding of basic Institutional Review Board regulatory processes, HIPAA, the Common Rule, current Good Manufacturing Practices (cGMP) of radiotracers, and Good Clinical Practice (GCP) is required.
Familiarity with all aspects of first-in-human FDA IND submissions of radiotracers is required, as is familiarity with the Division of Medical Imaging Products (DMIP) of the Office of New Drugs at the FDA.
Responsibilities will include both submission of regulatory documents as well as the ability to supervise and instruct other coordinators in the submission of these applications.
A minimum of 5 years’ experience in FDA document preparation and other research regulatory work is required.
Certification of Clinical Research Coordinators (CCRC) required.
Demonstrated knowledge of laws, rules and regulations relating to clinical trials and human subject research strongly preferred.
Excellent written and verbal communication skills.
Ability to analyze rules and regulations and provide compliance oriented practical advice within an individual and particularized clinical research context.
Ability to work independently.
Able to prioritize and balance multiple and complex tasks concurrently.
Demonstrated proficiency with MS software (Word & Excel).
Must possess a genuine commitment to the advancement of science and medicine.
Must have the ability to work well with a diverse group of people.
A minimum of 3 years experience in clinical research, or an equivalent combination of education and experience required.
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location:
This position is in the Department of Radiology-Research Entities. This position is for the Medical School Campus.
The hiring range for this position is $62,337 - $81,078 annually.
-Retirement Savings Plan -22 vacation days -8 Paid Holidays -Sick Time -Tuition benefits for employee, spouse and dependent children -Free Metro Link/ Bus pass -Free Life Insurance -Health, Dental, Vision -Health Savings Accounts (HSA) -Long Term Disability Insurance -Flex Spending Plan -Other Benefits
Med School HR website (medschoolhr.wustl.edu)
Internal Applicant Instruction:
This position is grade G13.
Please attach a copy of your most current signed performance evaluation (completed within the last 18 months) to your online account. If you have not received a performance evaluation, you may provide two current signed letters of recommendation (written within the last 18 months), preferably to include one letter from either a current or recent former supervisor. To attach these documents, go to: My Career Tools, Add Attachment, Attachment Type – Performance Reviews or Letters of Recommendation.
Washington University in St. Louis, a medium-sized, independent university, is dedicated to challenging its faculty and students alike to seek new knowledge and greater understanding of an ever-changing, multicultural world. The University offers more than 90 programs and almost 1,500 courses leading to bachelor's, master's and doctoral degrees in a broad spectrum of traditional and interdisciplinary fields, with additional opportunities for minor concentrations and individualized programs. The faculty is composed of scholars, scientists, artists and members of the learned professions. They serve society by teaching; by adding to the store of human art, creativity, understanding, and wisdom; and by providing direct services, such as health care.