Quality Coordinator

Position Description

Position Title:

Quality Coordinator

Reports to:

Quality Manager

Positions responsible for:

N/A

Key Relationships:

Internal

Quality Manager

Quality Team

Department Managers and Trainers

All NZCR Employees

External

CROs

Sponsors

Regulatory Authorities

Vendors

Purpose

Advancing Global Health

Our Values:

We Do What’s Right, We’re in It Together, We Strive for Excellence, We Find Better Ways

Position Purpose:

The purpose of this role is to provide support to the quality team and NZCR to ensure quality processes are maintained at the highest possible standard to enable NZCR to meet and exceed regulatory requirements.

Responsibilities:

Quality Coordinator

·         Assist in the development of a continuous improvement process for the business.

o    Help identify and action improvement opportunities.

·         Develop and maintain the electronic quality management system (Q-Pulse) by:

o    System administration activities; onboarding and offboarding staff.

o    Assisting department managers/trainers with Q-Pulse activities, as required.

o    Provide Q-Pulse training to staff.

o    Create and maintain reporting requirements by modifying and creating new searches and reports.

o    Identify and develop Q-Pulse improvement opportunities.

·         Document controller responsibilities; assist in the writing and reviewing of documents.

·         Support the quality team with audits:

o    Assist the quality team with internal audits to ensure studies and NZCR activities are conducted in accordance with SOPs, sponsor protocols, ICH-GCP and other applicable guidelines and standards.

o    Provide support to the quality team with vendor audits.

o    Assist in organising and hosting audits of NZCR conducted by our customers (contracted research organisations, sponsors, and regulatory authorities).

·         Follow-up on due/overdue non-compliances and other reportable events and assist departments with the timely completion of corrective and preventive actions.

·         Administrative support to the quality team, by.

o    Attend quality meetings and take meeting minutes.

o    Document control of paper documents.

o    Other tasks as required.

·         An understanding of clinical trial regulatory requirements, particularly ICH-GCP E6, to support quality activities.

·         Support the management of privacy and confidentiality regulatory requirements.

·         Occasional travel to other NZ locations may be required.

·         Any other activities as directed by the Head of Quality or Senior Quality Advisor.

Quality

·         Maintain compliance with all New Zealand Clinical Research standards, protocols, and regulatory requirements, adhering to Good Clinical Practice (GCP).

·         Regularly evaluates, documents, and refines clinical and operational processes to enhance accuracy, consistency, and overall quality.

·         Assists in training employees in quality standards, policies, and procedures, ensuring all team members understand and implement best practices.

·         Ensures accuracy, consistency, and currency in all research documentation and reporting, including accurate record-keeping, version control and timely updates.

Workplace Health and Safety

·         Champions a culture of health and safety, ensuring preventative measures are in place to minimize risk to team members and participants.

·         Actively identify and report health and safety hazards, accidents, incidents, injuries, and property damage.

·         Understands and complies with NZCR’s Health and Safety policies and procedures.

·         Maintains adherence to all safety standards and processes.

·         Commits to personal health and safety at work.

General

·         Undertaking any other appropriate duties that may be required.

Value Based Behaviours:

We Do What’s Right

·         Use the best judgement to make the right decision.

·         Follow through on commitments.

·         Show respect and compassion with a goal to always do good.

·         Act openly, honestly, and constructively.

We’re In It Together

·         Participate and build connections.

·         Value other contributions.

·         Celebrate the wide team’s success.

·         Consider the pact of their actions on others.

We Strive For Excellence

·         High has standards for themselves and do their best to achieve.

·         Follow process and protocols to their best ability and ask for help when they are stuck.

·         Share their knowledge and help others to succeed.

·         Learning from mistakes and identifying opportunities to improve.

We Find Better Ways

·         Look out for how to do things better.

·         Approach changes with an open mind.

·         Curious and proactive approach in seeking the best outcome.

·         Look for opportunities to grow and develop themselves.

Minimum Position Qualifications

Education

·         Bachelor’s degree or equivalent

·         Qualification in science, health, or similar industry (desirable)

·         Training in ICH-GCP (desirable).

·         Training is ISO 9001 (desirable).

Experience

·         2 years’ work experience.

·         Previous experience in a research/health/medical or laboratory role (desirable).

·         Previous experience working with Q-Pulse or another electronic quality management system (desirable).

Knowledge, Skills & Experience

Essential:

·         A good understanding and interest in quality systems.

·         A strong work ethic. Reliability, enthusiasm and a positive attitude.

·         Respect the privacy and confidentiality inherent in the role.

·         Ability to pay close attention to detail.

·         Excellent communication and people skills. Ability to communicate effectively, both verbal and written.

·         Ability to gather information/data, compile information, prepare reports, and meet timelines.

·         Strong organisation skills and the ability to prioritise work and work independently, as well as in a team environment.

·         A logical and organised approach to problem solving, and ability to put information in context/perspective.

·         Ability to learn new computer software programmes.

·         Skilled in the use of Microsoft Office applications e.g. Word, Excel, Outlook and Teams.

This position description is subject to review and alteration to reflect the changing requirements of your position and the business. Any changes to your position description would be done in consultation with you.

I have read and understood the above position description and accept all the above responsibilities incorporated.

Employee Name: ___________________________

Signature: ________________________________                  Date: _________________