Clinical Research Associate (Part-time, 24 hours per week)

  • Company:
    Douglas Pharmaceuticals
  • Location:
  • Salary:
    negotiable / month
  • Job type:
  • Posted:
    2 days ago
  • Category:

Douglas is one of New Zealand’s greatest pharmaceutical success stories with an ever-expanding footprint into global markets. We’re working to develop, trial, manufacture, test, pack and distribute the very best medicines, nutraceuticals and products around the world.At Douglas there are around 800 of us – including top scientists, researchers, manufacturers, regulators and engineers, and together we’re on a mission to make high quality, effective and accessible products for people who need it.We’re helping people with conditions like depression, schizophrenia, breast cancer, heart failure, severe acne, as well as people who need antibiotics and medicines to support their immune system.The roleWe are looking for a Clinical Research Associate to work within our Clinical Operations Team to ensure clinical research studies are conducted in accordance to local and international regulations, International Conference of Harmonization (ICH) Good Clinical Practice (GCP) guidelines, global and local regulatory requirements and Company SOPs.This is a permanent part time (24 hours per week) role, with some flexibility in location – ideally Auckland, Tauranga, Christchurch or Dunedin.You will have transactional oversight and be responsible for assisting with management of all aspects of Clinical Trials. This will include site selection, ethics and regulatory submissions, study initiation and study medication management. Study recruitment, site monitoring and close out visits, liaising with consultants and reporting are also key elements of this role.What you’ll bringTo be considered for this role you will possess the following skills and attributes:Tertiary qualifications in Clinical; Life Science FieldMinimum of 6 months clinical monitoring experience in New Zealand.Perform Monitoring activities related to study lifecycle environment including study start up, monitoring and close out.Manage study progress by tracking regulatory submissions, recruitment and data query resolution, ensure quality and integrity of sites and escalate quality issues as appropriateSound knowledge of applicable clinical research regulatory requirements – GCP -ICH guidelines.Strong customer focus.Good command of English, and strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.Be able to use functional expertise and exercise good judgment;·demonstrated business ethics and integrity.Attention to detail.Organisation and Planning – ability to work in a self-driven capacity and an ability to adapt and be flexible to changing prioritiesBe a New Zealand citizen/Permanent resident or have appropriate visa that permits you to work in New Zealand.Site Management is essential in this role to ensure that clinical trials are conducted and documented as per ICH-GCP guidelines, global and local regulatory requirements and Company SOPsWhat we offerThese are exciting times at Douglas with anticipated growth ahead and we offer -Competitive remuneration and benefits.We will invest in your development, professional and personal development is not just encouraged, but expected.Supportive team and diverse team culture.A fantastic open plan office, with the latest in communication technology and a subsidised cafeteria onsite.Working from home flexibilityNext stepsIf you’re invited to complete a video interview as the next stage of your application, we’d love you to embrace it. Video interviews allow more people the opportunity to demonstrate their abilities to the hiring manager in a new and innovative way giving you a better chance of securing your ideal role. Relax, be yourself and don’t worry, we all feel a bit awkward in front of the camera.