Clinical Trials Study Coordinator
Permanent, full-time (or fewer hours negotiable across five days)
We are a private medical oncology facility on the North Shore, Auckland, dedicated to expertise, innovation and care in the treatment and survivorship of cancer.
About the opportunity
We are looking for an experienced Study Coordinator to join our research team.
This role is responsible for the coordination of international clinical trials research projects, with a trial commencing in the new year.
Duties for the position include:
- participation in the development of study documentation pre-trial;
- supports participant recruitment and scheduling of patient visits;
- completes data collection, data entry and monitoring of data ensuring highest-level data integrity;
- reviews and tracks regulatory documents;
- adherence to clinical trial protocols and compliance with all relevant ICH-GCP guidelines, regulatory and company policies;
- Prepares Ethics Approval submissions;
- preparation of the trial data for onsite monitoring visits.
You will bring clinical research coordination and organisational skills including:
- at least two years’ experience in clinical trial coordination;
- a clear understanding and management of participant and research confidentiality and data integrity;
- strong organisational skills and experience liaising with sponsors and suppliers;
- a caring and engaging manner with patients;
- completion of either a bachelor science or health science degree or other relevant health field qualification;
- demonstrated competency with clinical trials data and databases;
- experience with research specimen collection and processing;
- experience managing budgets, interim and final study reports;
- ability to work independently and collaboratively within a multi-disciplinary team.
Ideally, the successful applicant would be able to commence in the role in December (whilst taking into account leave plans for the Christmas period).
If you would like a confidential discussion with us, contact the Chief Operating Officer on 021 682 673
Or to apply, please send a covering letter and your resume to Nardia.firstname.lastname@example.org
Who we are
CGM Research Trust is a New Zealand (Christchurch -based) leader in clinical research trials with 35 years’ experience in phase II and III research studies. We are a charitable research trust with a small, hardworking & close-knit, fun team.
We pride ourselves on delivering high quality clinical research using, innovative recruitment strategies & giving exceptional patient care. Our clinical trials include a wide range of specialties focusing on improving outcomes for people with conditions that are difficult to treat and where there is an unmet need.
About the role
You will be part of a team responsible for planning, coordinating and administration of clinical trials. We are looking for:
- Senior registered nurse with advance nursing skills (10 yrs +), a broad knowledge base, a wide range of experience & interests
- Previous research experience preferred but not essential full training will be provided for the right candidate
- Excellent interpersonal, verbal and written communication skills & the ability to build good rapport quickly
- the ability to manage time efficiently and to multi-task
- Have the ability to work autonomously but also as part of a team in a busy office & off site
- Be highly organized with meticulous attention to detail
- A “can do” attitude with initiative & the ability to “think outside the box”
- The ability to work on multiple projects at one time, work to tight deadlines and to accept and respond positively to change
- Good computer skills with knowledge of Microsoft 365 office applications (Word & Excel) as well as data entry
This is an exciting opportunity for a senior nurse with a strong customer service ethos and a curiosity to learn both about this role and the research it supports. You can become part of a great team, (help improve outcomes for patients) and advance clinical research in New Zealand.
This position is permanent full time, 5 days a week, 40 hours per week. (we can offer some flexibility)
If you are looking for a new challenge and think you have what we are looking for we want to hear from you.
Applications should include a cover letter and CV and emailed to: Kristin@accent.net.nz
Avance Clinical – our most important asset is our people. We offer a work environment and a culture that values honesty and respects its people.
Avance Clinical is a Contract Research Organisation which offers specialised services supporting clinical drug development for the pharmaceutical and biotechnology industry.
This is a permanent position, we are open to it being either part time (0.8) or full-time and home based from anywhere in New Zealand.
As we continue to grow, we want our people to grow with our organisation. We offer training and career development opportunities to build the skills and progress the careers of our employees.
Acting as the primary link between sites and sponsor, you’ll be responsible for:
- Performing start-up, initiation, monitoring and close-out visits along with maintaining appropriate documentation
- Developing your skills and knowledge on clinical trials within a wide scope of therapeutic areas
- Monitoring all aspects of studies to ensure compliance with GCP, study protocol and regulatory requirements and prepare monitoring reports
- Development and review study protocols and other study-related documents
- Preparing ethics submissions and assisting in the preparation of Clinical Study Reports.
Prior experience monitoring clinical trials, ideally within Australia and/or New Zealand. It is essential that you have a degree in science or other healthcare-related discipline, between 1 to 3 years of experience working as a CRA in the pharmaceutical or CRO industry. You will need solid knowledge of Australian and New Zealand drug development process, clinical trial monitoring procedures, GCP guidelines, and medical terminology is essential. On top of this, you will need to be able to show initiative and work well autonomously, within minimal supervision.
- Reputable growing CRO with stability
- a challenging and stimulating environment where what you do matters
- a diverse and inclusive culture with a strong emphasis on team collaboration
- training and career development opportunities
- attractive remuneration
- Join our team by submitting your CV along with a cover letter outlining your skills and experience – please submit as one PDF document.
- As we receive a high volume of applications for our vacancies, we will only contact you directly, should you be successful through to the next stage of our recruitment process.
- You must also have full NZ working rights to be considered.
Please may CVs be submitted to:
Please apply via our website using the following link
Do you have expertise in, and passion for, Clinical Research? Would you like to apply your expertise to impact the effectiveness and medication of products in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! We’re investing to enhance our understanding of disease as we work towards creating the next generation of therapeutics and pioneering new approaches to better predict clinical success.
What you’ll do
You are a self-motivated, proactive, and passionate individual focused on delivering quality outcomes in a fast-paced environment. The new Clinical Research Associate (initial 12 month contract, full-time basis), will be involved in effective site management across a number of high-profile studies as well as all aspects of the study from preparation, initiation, monitoring, and closure. To be successful in this role you will have good knowledge of Clinical Study Management across monitoring, study drug handling and data management. You will ideally have experience working in a similar capacity, have excellent knowledge of international guidelines ICH-GCP, relevant local regulations and a basic understanding of the drug development process.
Key responsibilities include, but not limited to:
- Contributing to the selection of potential investigators and training, supporting, and advising investigators in regards to study related matters including Risk Study start-up and regulatory maintenance
- Initiating, monitoring, and closing study sites in compliance with AZ Procedural Documents. This includes participating in Local Study Team (LST) meetings and sharing information on patient recruitment and study site progress
- Updating CTMS and other systems with data from study sites
- Performing monitoring visits (remotely and on site), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan
- Performing regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study
Essential for the role
- Bachelors degree in related discipline, preferably in life science, or equivalent qualification
- Excellent knowledge of international guidelines ICH‐GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
Desirable for the role
- Ability to work in an environment of remote collaborators.
- Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Good analytical and problem‐solving skills.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Familiar with risk‐based monitoring approach including remote monitoring.
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA). As an organisation we stand with confidence on our gender equality initiatives including pay equity, leadership development programs, and zero tolerance for gender-based harassment. This achievement exemplifies our commitment to building high performing, inclusive and diverse teams that collaborate across our enterprise, aligned to our values and strategic priority of being a Great Place to Work.
So, what’s next?
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
- Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have a seat available and we hope it’s yours.
- If you’re curious to know more than please reach out to Danielle Jones.
Where can I find out more?
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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