Assistant Director, Pediatric Clinical Research

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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.

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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.

'',''!*!

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.

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• 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.

'',''!*!

• 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.

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The University of Pittsburgh is an equal opportunity employer / disability / veteran.

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