Children's Hospital of Pittsburgh of UPMC Division of Medical Genetics is currently recruiting a Research Regulatory Coordinator to this nationally recognized research institution participating in many federally funded and industry sponsored clinical trials. For part of this position, the individual will assist the Principal Investigator (PI) and the division's senior regulatory affairs coordinator with the preparation and maintenance of regulatory documents including submissions to the sponsor, Institutional Review Boards (IRB), Food and Drug Administration (FDA), and other regulatory authorities. The remainder of the position will be spent coordinating the division's multiple Phase IV post-marketing surveillance trials and observational studies.
Tasks would include subject recruitment, enrollment, scheduling, and study conduct. Knowledge of and experience with data collection/abstraction and data entry desired. Knowledge of medical terminology preferred. Effective communication skills, meticulous record keeping, and strong organizational skills are required. Some travel may be required to study meetings but not on a regular basis. Bachelor's degree is preferred. Flexible hours (day light, some evenings, weekends) will be necessary.
This position is located at Children's Hospital of Pittsburgh of UPMC in Lawrenceville. TB test and PA Child Abuse History Clearance, PA State Police Criminal Record Check and FBI Criminal Record Check will be required as a condition of employment. EEO/AA/M/F/Vets/Disabled.
Minimum Related Experience Level Required
1-2 years experience
Additional Education and/or Experience Essential to the Position
Bachelor's degree preferred. Regulatory experience within the University of Pittsburgh a plus.
Child Protection Clearances
The following PA Act 153 clearances and background checks may be required prior to commencement of employment and as a condition of continued employment: PA State Police Criminal Record Check, FBI Criminal Record Check, PA Child Abuse History Clearance.
Scheduled Work Hours
Work Schedule to Vary
If Varied Work Schedule, Please Specify
The typical Monday Friday schedule will be followed. Travel to meetings may require occasional weekend travel.
If Part Time, Actual Standard Weekly Hours
The University offers an excellent comprehensive benefits package for all full-time and part-time regular employees including:
Education benefits and a retirement plan with employer match
Group medical insurance, life insurance, and optional vision and dental insurance
Free transit service within Allegheny County for employees of the Oakland campus (Port Authority Transit)
Time off benefits including vacation, sick and personal time
Founded in 1787, the same year the U.S. Constitution was signed, the University of Pittsburgh is one of the oldest institutions of higher education in the United States. One of three state-related research universities in Pennsylvania, Pitt is a member of the Association of American Universities (AAU), which comprises 62 preeminent doctorate-granting research institutions in North America.
Pitt... faculty members have expanded knowledge in the humanities and sciences, earning such prestigious honors as the National Medal of Science, the MacArthur Foundation’s “genius” grant, the Lasker-DeBakey Clinical Medical Research Award, and election to the National Academy of Sciences and the Institute of Medicine. Pitt scientists have defeated polio, unlocked the secrets of DNA, lead the world in organ transplantation, and pioneered TV and heavier-than-air flight, among numerous other accomplishments.
Pitt students have earned Rhodes, Goldwater, Marshall, and Truman Scholarships, among other highly competitive national and international scholarships.
Alumni have pioneered MRI and TV, won Nobel and Pulitzer Prizes, led corporations and universities, served in government and the military, conquered Hollywood and The New York Times bestsellers list, and won Super Bowls and NBA championships.