Clinical Trial Associate / QA Coordinator (Home Based Contract)

Location: Bathgate  |  West Lothian  |  Scotland
Sector: Life Sciences
Consultant: Chris Hutchinson
Job Reference: HQCHCTA/QAC
Salary: £20000 - £30000
Job Status: Contract / part time

Job Title

Clinical Trial Associate / QA Coordinator

Line Manager

Quality Director

Job Description / Purpose

My Clinet is a small specialist clinical trial technology company with offices in the UK, and Budapest. Since 2002 they have focussed on building bespoke Interactive Response System solutions.

Due to continued growth we are looking for the right individual to assist the Quality Director in maintaining the QMS system in accordance with ISO9001:2015, ISO27001:2013 and GCP along with helping to prepare and maintain the documentation for each new project.

Additionally, we are looking for someone who can plan and conduct basic audits/documentation checks on the QMS system and ongoing projects.

As a small company you will have valuable exposure to a wide range of functions/experience that would never get working for a large company.

At HMD Clinical we strive to be fast, focused and flexible and pride ourselves on a very loyal customer base with most work coming from repeat business.

Responsibilities

  • Maintaining the QMS System (checking review dates, checking document quality/accuracy, ensuring documents reflect current practices, reviewing objectives)
  • Planning audits, maintaining audit schedules for QMS and projects
  • Assisting/conducting basic audits of the QMS system
  • Conducting project documentation reviews (ensuring that all project documentation in place at regular intervals as per audit schedule)
  • Participating in monthly management meetings
  • Raising/tracking non-conformances
  • Managing project logs
  • Participating in external audits (customers and ISO certifications)
  • (Longer term) Assist in the review/testing of new projects to ensure they conform with the project requirements specification and the production of user guides/training material

Activities

  • Home based
  • Required to attend offices in Bathgate, Scotland once per week
  • Attend ISO audits

Knowledge, Skills and Experience

Knowledge

•          An understanding of the clinical trial industry

•          An understanding of the principles of quality management and systems

•          An understanding and experience of working to GCP guidelines

Skills

•          Effective time management and task prioritisation

•          Ability to problem solve by identifying, collating and reviewing related information to develop and implement options and solutions

•          Written and oral comprehension and communication skills to communicate and convey information or requirements effectively to internal and external stakeholders

•          The ability to adapt to change and understand new concepts

•          Quick learner

•          Self-motivated with excellent attention to detail

•          Flexibility to perform other tasks as required in a small company environment

•          Confidence and integrity with a professional approach to work and colleagues

•          Pro-active problem solving approach

Experience (Essential)

•          Minimum 2 years in clinical trial industry

Experience (Desirable)

•          Computer system testing

•          Writing user training materials

•          ISO9001:2015

•          ISO27001:2013