Regulatory Affairs Coordinator
Med-Pediatrics - Pennsylvania-Pittsburgh - (22001905)
This position is responsible for the coordination and implementation of research studies, overseeing protocol development, and developing institutional informed consent documents for protocols within the University of Pittsburgh’s Division of Medical Genetics. The incumbent is responsible for all aspects of submitting protocols to the Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), and to other regulatory agencies, such as the FDA. The incumbent will be responsible for various aspects of clinical trials research, such as monitoring protection of subjects and subject’s rights through IRB regulations, preparation of adverse event experience reports, construction, and monitoring, of case report forms, and report preparation. They will assist the clinical research manager in managing a system for planning and workflow related to the clinical research activities and the IRB and HRC committees. There is a potential for hybrid work after completing provisional period with approval from manager. Equivalent relevant work experience may be substituted for degree requirement. This position is located at the UPMC Children’s Hospital of Pittsburgh in Lawrenceville. PA Child Abuse History Clearance, PA State Police Criminal Record Check, and FBI Criminal Record Check will be required prior to the start of employment. Also, a current TB test will be required as a condition of employment. EEO/AA/M/F/Vets/Disabled.
Bachelor's degree with 1-2 years of experience required. Equivalent relevant work experience may be substituted for degree requirement.The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vetsThe University of Pittsburgh requires all Pitt constituents (employees and students) on all campuses to be vaccinated against COVID-19 or have an approved exemption. Visit coronavirus.pitt.edu to learn more about this requirement.
Department Details Equivalent relevant work experience may be substituted for degree requirement.
Assignment Category Full-time regular
Job Classification Staff.Administrator.II
Campus Pittsburgh
Minimum Education Level Required Baccalaureate
Minimum Experience Level Required 1-2 years experience
Work Schedule Shift determined by manager.
Hiring Range $26,988.00 - $43,212.00
Relocation Offered No
Visa Sponsorship Provided No
Background Check For position finalists, employment with the University will require successful completion of a background check
Child Protection Clearances The following PA Act 153 clearances and background checks are 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.
Required Documents Resume
Optional Documents Cover Letter