QTS Nurse

Job Description

Summarized Purpose

Oversees and coordinates training and/or quality programs and activities. Schedules training for newemployees, identifies training gaps and develops and delivers training programs and curriculums topromote continuous improvement.

A day in a life

• Leads or performs quality reviews of MIA and MIS staff customerinteractions and associated documentation and coordinates and assists with corrective action plans ifneeded.
• Ensures program compliance with corporate, departmental and client policies and proceduresincluding SOPs and applicable health authority regulations (e.g. FDA, EMEA), as well as standard inquirymanagement and documentation practices.
• May serve as a liaison with the clients for training or qualitytopics.
• Schedules, develops and delivers training courses and content for all staffmembers. Conducts product or disease state training for staff members asrequired.
• Monitors effectiveness of training and observes training sessions, trends andassesses changes in employee performance. Modifies training to increasebeneficial outcomes.
• Integrates training with the client while negotiating organizational differences inculture, management structure and staffing. Liaises with the client, departmentmanagement and staff for all training related topics. Maintains program trainingdocumentation in audit-ready status.
• Conducts call and documentation review of staff members' work and monitorsaccuracy and completeness of information provided, including clinical content.Ensures program consistency relative to compliance with the organization andclient policies/procedures.
• Evaluates quality trends across the program and provides feedback to themanagement team. Tracks and documents Quality Events. Develops continuousimprovement initiatives based on gaps and trends identified.
• Provides support for program-related audits.
• May assist with department projects

Education and Experience:

• Bachelor's degree in nursing or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to2-5 years).
• In most cases a license will be required
• In some cases, an equivalency, consisting of a combination of appropriate education, trainingand/or directly related experience, will be considered sufficient for an individual to meet therequirements of the role.

Knowledge, Skills and Abilities:

• Strong understanding of applicable health authority (e.g. FDA, EMA) or local regulations
• Strong clinical trial knowledge, preferred
• Ability to work US daytime business hours
• Good knowledge of drugs and drug information
• Ability to perform call/document review, including complex clinical discussions and provide clear andconcise feedback
• Firm organizational and time management skills
• Strong attention to detail and ability to multi-task
• Strong verbal and written communication skills
• Solid problem-solving skills
• Strong computer skills including Microsoft Office
• Ability to train and mentor others
• Excellent language skills (comprehension, speaking, reading and writing) must be demonstrated if theposition requires languages other than English
• Ability to work in a team environment and/or independently as needed