Senior Clinical Research and Regulatory Coordinator
University of Pittsburgh
August 10, 2018
The Senior Clinical Research and Regulatory Affairs Coordinator position will serve as a resource to investigators and clinical research team members regarding preparation, submission, and on-going oversight of clinical research protocols and regulatory documents. The incumbent's duties stafwill include regular interactions with FDA and NIH that are carried out via critically important IND submissions and regular reports updates to FDA. In addition, will assist PI and department to obtain industry sponsored trials with financial agreements. Also will obtain IRB/FDA and NMDP approval to allow department to make preparations to the intrabone/intraosseus cord blood transplant.
The coordinator position will work directly with investigators, study coordinators, and pediatric research grants managers to prepare protocols for submission to both the Institutional Review Board (IRB) and UPMC Office of Sponsored Programs and Research Support (OSPARS) when indicated. The coordinator will maintain regulatory records for existing protocols and assist with budget preparation and fiscal accountability for the protocol operations.
The position will also assist in the coordination of oncology clinical trials by collaboration and assessment of patients' diagnosis and condition status for the Children's Oncology Group, PBTC, ASBMT, etc., along with the patient's treatment team of physicians, nurses and physician extenders.
The incumbent will assist in obtaining consents and maintaining records and data pertaining to clinical research.
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.
Internal Number: 163826
About University of Pittsburgh
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.