Assistant Director, Pediatric Clinical Research

Assistant Director, Pediatric Clinical Research

Med-Pediatrics Research Administration - Pennsylvania-Pittsburgh - (26006410)

Equivalent relevant work experience may be substituted for degree requirement. This position is located at 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.

Job Summary

Manages the clinical operations of a research program and oversees clinical research policies in human trials. Oversees the development and implementation of standard operating procedure (SOP) manuals in clinical research; ensures the program meets all quality assurance activities. Oversees development of standards, internal and external site visits and audits, research protocol budgets, subject enrollment, protocol implementation.

Essential Functions

• Manages clinical operations for a research program, including overseeing implementation of new research protocols, ongoing studies, reporting events, and effective communication with investigators. Creates, implements, and oversees clinical research policies in human trials.

• Oversees the development and implementation of standard operating procedure (SOP) manuals in clinical research; ensures the program meets all quality assurance activities.

• Oversees participation in site visits, including internal and external audits. Develops and manages strategic timelines; adheres to budgetary guidelines.

• Streamline current clinical assessment activities, incorporating new fluid/plasma biomarkers and new PET imaging biomarkers into evaluations at both baseline and annual follow-up.

• Lead Study Program Manager for the entire clinical trials platform with new treatment arms that will be started for younger level participants, including monitoring home nursing teams providing home infusions to clinical trial subjects who actually live across the United States.

• Staff leadership role on the Clinical Core and related studies that cross multiple departments and monitoring the day-to-day operations of the Clinical core, developing strategic planning with faculty leadership.

• Supervises staff, including hiring, distributing and reviewing work, performance reviews, and documenting disciplinary actions and other human resource administration. Manages work schedules and approves timecards. Provides professional development opportunities.

• Oversees and enrolls patients/subjects into research studies/clinical trials. Reviews medical records and/or conducts physical exams for patient recruitment.

• Manages protocol implementation; trains staff to ensure protocol adherence.

• Ensures all protocol and regulatory standards adherence.

Physical Effort

Light.

Assignment Category: Full-time regular

Job Classification: Staff.Assistant Director - Clinical Research Nurse

Job Family: Research

Job Sub Family: Clinical Research - Nursing

Campus: Pittsburgh

Minimum Education Level Required: Bachelor's Degree

Minimum Years of Experience Required: 5

Will this position accept substitution in lieu of education or experience: Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement.

Work Schedule: This position will require flexibility with shift/hours and occasionally will be required to work on the evenings and weekends.

Work Arrangement: Hybrid: Combination of On-Campus and Remote work as determined by the department.

Hiring Range: TBD Based Upon Qualifications

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

PI287709332