Job Description

Job Title: Regulatory Specialist Supervisor
Job ID: 706845
Status: Full-Time
Regular/Temporary: Regular
Hours:
Shift: Day Job
Facility: UPMC Cancer Centers
Department: CRS Administration HF
Location: 5115 Centre Avenue, Pittsburgh PA 15232

Description

Purpose:
The Regulatory Specialist Supervisor is a highly skilled, experienced and trained professional who is responsible for overseeing regulatory operations functions of clinical research trials provided through the University of Pittsburgh Cancer Institute (UPCI) and UPMC Cancer Centers, involving multi-agent and investigational agent therapies. This individual is responsible for assisting the Director/Assoc Director of Clinical Research Services in the planning and execution of the daily operations within the disease center programs to assure that the GCP guidelines, Office of Research, Human Protections (OHRP), Food and Drug Administration (FDA) and UPCI/UPMC policies and procedures are followed during the conduct of the clinical research trials. Essential to this component is the commitment to recruit, train, develop, and retain regulatory/clinical staff for the UPCI disease centers.

Responsibilities:
  • Consistently displays a level of professionalism in attitude, communications, and actions that is commensurate with management potential, and at all times promotes the UPMC and UPCI corporate vision and mission. Assists research team in their ability to work in a timely and efficient manner. Analyzes clinical and behavioral situations, identifying learning opportunities to improve patient care and clinical research practices.
  • Designs new processes and procedures within the regulatory/clinical department and CRS at large.
  • Develops protocol required documents and coordinates protocol implementation as needed. Monitors and facilitates completion of all protocol required data elements and ensures all electronic data capture is complete and accurate.
  • Ensures research documentation is comprehensive and facilitates protocol compliance; communication among colleagues; good clinical research practice; and patient safety. Takes responsibility for identifying his or her ongoing professional development needs and independently seeks resources and opportunities to meet those needs, such as through membership in nursing, clinical specialty or research organizations
  • Functions as a direct supervisor for regulatory/clinical services, processes, and personnel. Responsible for delegating tasks within all disease centers, monitoring productivity and workload, and shifting assignments and responsibilities as needed. Responsible for assisting in performance management, performance development, and completion of yearly evaluations for direct reports.
  • Identifies opportunities to improve research practices and patient satisfaction by serving or leading teams as a change agent to launch innovations in patient care/satisfaction, clinical research, or support a healthy workforce. Actively participates in department or unit-specific quality improvement efforts.
  • Identifies opportunity for quality improvement to colleagues and management Serves as a role model of professional nursing practice as demonstrated by adherence to ethical practices during the conduct of clinical trials to protect the rights and well-being of patients and the collection of quality data
  • Independently partners with UPMC and Pitt departments (IRB, O3IS, CTO, etc.) to provide quality service. Independently partners with external customers (industry sponsors, NCI, FDA, etc.) to provide quality service.
  • Interviews and hires new regulatory/clinical staff. Orients, trains, and mentors new Regulatory Specialists /Clinical Staff when assigned or appropriate. Acts as a resource for the Assistant Clinical Director of CRS and the Program Managers. Completes special projects as assigned by the Director of CRS.
  • Serves and leads various Clinical Research Services committees that involve dedication, commitment, and contribution. Acts on behalf of the Director of Clinical Research Services when necessary.

Qualifications

  • Associate's degree with five (5) years of experience required.
  • Prior knowledge and use of MS office software products and the ability to operate PC database applications.
  • Must possess excellent detail oriented, outstanding organizational and time management skills to complete several projects/tasks simultaneously.
  • Ability to work independently with minimal supervision, possess strong leadership and management skills, including excellent interpersonal, project management, presentation, and problem solving skills.
  • A proven track record is required to demonstrate these skills.
  • Required to maintain strict confidentiality within and outside the organization.

 

Licensure, Certifications, and Clearances:

  • Act 34 Criminal Clearance

UPMC is an equal opportunity employer. Minority/Females/Veterans/Individuals with Disabilities

Salary Range: $26.64 to $44.88

Union Position: No

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