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Job Title CTO QA/TRAINING SPECIALIST

Position Number 8150281

Job Category University Staff

Job Type Full-Time

FLSA Status Exempt

Campus Maywood-Health Sciences Campus

Department Name CBCC RESEARCH

Location Code CBCC RESEARCH (06310A)

Is this split and/or fully grant funded? Yes

Duties and Responsibilities 

This position is responsible for the development, management and organization of the Quality Assurance and Training functions to ensure that CTO employees are properly trained to perform their assigned duties. The Quality Assurance/Training Specialist will be responsible for monitoring, auditing, and proposing measures to correct or improve the CTO processes in order to meet established quality standards. The Quality Assurance/Training Specialist will be responsible for the training program delivery, as well as providing ongoing infrastructure development and maintenance of the CTO core curriculum in the Cancer Center CTO.

  • Develops and provides competence-based orientation for new employees. Provides content delivery as appropriate; closely manages the training, mentoring, and preceptorship, and evaluates competencies for all employees. Provides retraining as required.
  • Develop and implement training programs – includes researching and creating content, building a curriculum based on current standards of practice that ensures the highest quality of care through education, hands-on training, and information sharing through various mediums (in-services, CME courses, CITI Training, etc.) Responsible for the onboarding of new CTO employees, and ongoing training as required. Will measure quality metrics and determine how best to maintain high skill and customer service standards.
  • In conjunction with the CTO Manager, identify and assess professional and leadership development needs and performance gaps for all CC CTO staff. Enhance professional growth and development of employees by providing training and continuing education through presentations, in-services and other educational programs. Works with staff regarding career path options.
  • Provide clinical research operational orientation for new faculty. 
  • In conjunction with the CTO Manager, reviews CTO SOPs on a regular basis (at least annually). Ensures that SOP training is completed for new employees and as needed for all staff.
  • Ensures all aspects of Regulatory Compliance: Coordinate the Protocol Review and approval process for all cancer clinical trials; Coordinate the Data Safety Monitoring Committee (DSMC) and collaborate with the committee to develop processes to ensure regulatory compliance; Member of the DSMC; Oversight and coordination of NCI sponsored Quality Assurance Audits; Monitor federal, state and institutional requirements and regulations and ensure policies comply with requirements; Collaborate with the Institutional Review Board, Office of Research Services, Corporate Compliance and cooperative groups in ensuring regulatory compliance.
  • Ensures compliance in our role as an NCI sponsored Cooperative Group multi-institutional sponsor. Oversight of affiliate network institutions to include development and implementation of a formal affiliate program that involves active, regular communication, auditing and training as required. Ensures compliance with data reporting requirements. Develops efficient systems to ensure timely completion and quality data. 
  • Implement and lead the QA Program for all CC CTO IITs for ongoing and future studies. Ensure compliance with our role as a member of an NCI sponsored Phase II Consortium.
  • Performs other duties as assigned
  • Minimum Education and/or Work Experience
  • Bachelor’s degree from a four-year college or university. Master’s or advanced degree in Nursing, Pharmacy or other health related discipline preferred. 
  • A minimum of 5-7 years experience in clinical healthcare setting involving operations management, quality data/informatics, and/or healthcare systems implementation and training. At least 5 years of clinical trial experience, with a strong focus on training development and delivery. 
  • Qualifications
  • Bachelor’s degree from a four-year college or university. Master’s or advanced degree in Nursing, Pharmacy or other health related discipline preferred.
  • A minimum of 5-7 years experience in clinical healthcare setting involving operations management, quality data/informatics, and/or healthcare systems implementation and training. At least 5 years of clinical trial experience, with a strong focus on training development and delivery.
  • Knowledge of current regulatory expectations and industry standards relating to compliance; possess a working knowledge of quality systems. Direct experience in leading audits and regulatory activities preferred.
  • Knowledge of oncology clinical research, project management, clinical trial management-oversight, site management-monitoring, data management, pharma covigilance/drug safety, quality management, audits/regulatory agency inspections, regulatory compliance, as well as the interpretation and application of relevant regulatory agency documents/requirements to these topic areas.
  • Experience in the development and delivery of training materials and tools. Excellent presentation, communication and engagement skills with the ability to communicate in a positive and professional manner.
  • Strong verbal and written communication skills and ability to form cross functional leadership partnerships to accomplish goals.
  • Organizational and time management skills, including classroom coordination and management. Collaborative, energetic, team-oriented professional who is comfortable with change. Ability to be autonomous and operate with limited direction.
  • Advanced Microsoft office skills (Word, PowerPoint, and Excel).

Certificates/Credentials/LicensesPreferred Qualifications:

  • Registered Nurse license – State of Illinois
  • Clinical Research Certification (SOCRA or ACRP).

Computer SkillsAdvanced Microsoft office skills (Word, PowerPoint, and Excel). Clinical trials management system (Velos) experience preferred.

Supervisory Responsibilities No

Required operation of university owned vehicles No

Does this position require direct animal or patient contact? Yes

Physical Demands Standing

Working Conditions None

Open Date 10/05/2023

Close Date 

Special Instructions to Applicants 

Diversity and Inclusion Statement 

Diversity, Equity, and Inclusion

As one of the nation’s largest Jesuit, Catholic universities, Loyola University Chicago fosters a transformative cultural experience that honors diversity, equity, and inclusion. We are committed to not only recruiting, but also retaining a diverse, mission driven workforce and enabling a culture of inclusiveness in an environment that values service excellence, stewardship, personal well-being, and professional development for all of our employees. Loyola University Chicago supports its staff and faculty with a wide array of affordable, comprehensive and competitive benefits centered on health and wellness, financial security, equity, and work-life balance. We actively seek those who wish to join our faculty, staff, and students in a community of diverse opinions, perspectives, and backgrounds supporting our Jesuit mission and striving toward the same goal of being persons for and with others.

Quick Link for Postinghttps://www.careers.luc.edu/postings/26503

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