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• Aspiring Clinical Research Associates (CRA)

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Aspiring CRAs

So, you’d like to become a Clinical Research Associate (CRA)? Read on for some useful tips from NZACRes…

What does a CRA do?

A CRA monitors the running of clinical trials. This is achieved by conducting onsite monitoring visits, remote site monitoring calls and liaising between the sites and the project team. A typical job description looks like this:

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol ​and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site activation.
• Participates & provides inputs on site selection and validation activities.

What qualifications are required to be a CRA?

• A degree in life sciences or other health-related discipline
• A masters or PhD may be advantageous. A relevant PhD may also be helpful in securing promotions to more senior positions in this career path.

Some useful terminology:

• Site: the clinical site where the patient takes part in the clinical trial.
• Sponsor: the pharmaceutical or medical device company that is paying to conduct the clinical trial.
• CRO: Clinical Research Organization/Contract Research Organization: a company hired by the Sponsor to oversee the conduct of the clinical trial. Note: some Sponsors may not use CROs and instead have their own dedicated CRAs.
• CRA I or in-house CRA: This is an entry-level position and usually works under the supervision of more senior CRAs.
• CRA II : an independent CRA. Can perform monitoring visits without supervision.
• SCRA: Senior CRA – an experienced CRA. May also take on lead CRA responsibilities and oversee a team of CRAs.
• Oncology CRAs: oncology trials have additional clinical monitoring challenges. Some CROs/Sponsors may seek CRAs with oncology experience.
• SSU: Study Start-Up – work alongside CRAs. SSU specialists collect the Essential Documents (ICH-GCP Section 8) required prior to the start of the study. Once a site has been selected and prior to the Site Initiation Visit, the SSU team will handover the site to the CRA for initiation. Depending on the CRO, SSU specialists may retain HDEC and regulatory responsibilities during the project life-cycle.
• CTA: Clinical Trials Assistant – assist CRAs with various aspects of the project including TMF filing, ISF creation, updating study documents.
• CMA: Central Monitoring Associate – similar to a CRA but works remotely and does not visit sites in person. CMAs analyse the data collected and identify risks and trends for the CRAs to follow up with the sites.

What should you do next?

• Join NZACRes! Members enjoy access to the video library of relevant clinical research topics to NZ. We recommend that you watch the ‘Careers’ webinar, available within our video library.  NZACRes membership will help to show that you’re interested in keeping up to date and connecting with local industry experts.
• Complete a FREE online GCP course and proudly display this on your CV and LinkedIn page. Members have access to a list of free courses under the Members Resources page ‘Online Resources’ .
• Make sure your LinkedIn profile is up to date. See our LinkedIn tips article here:  https://www.nzacres.org.nz/nz_jobs/linkedin-tips/
• Make sure your CV is up-to-date and professionally presented. We recommend you use a research template, such as the Transcelerate CV template. 
• Search LinkedIn and Seek for clinical research jobs. If you can’t find a CRA I position, try talking to recruiters hiring for CRA II positions. If all the positions require “industry experience”, meaning experience working on clinical trials conducted according to ICH-GCP, you may like to try looking for other positions e.g. clinical research coordinator, clinical research assistant, clinical trial assistant, research recruiter, data entry, research nurse (if you have a nursing background), clinical trials pharmacist (if you’re a pharmacist), lab assistant. Please note that you’re trying to get experience on industry Sponsored clinical trials – testing new medicines or medical devices – conducted according to ICH-GCP (or ISO14155 for medical devices). The clinical studies conducted in academia may not meet these criteria and, while valuable, may not help you to gain industry experience.
• Search for positions but don’t apply months in advance of when you’re ready to start. If you’re finishing up a doctoral thesis, bear in mind that the company hiring CRAs is probably trying to replace a CRA who has already left the project and needs to get the new recruit trained and deployed as soon as possible. Most companies will not be able to wait for more than a month or so for a new employee to start.
• Attend NZACRes events and get networking!
• Contact [email protected] if you have further questions

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Join our Research Community

Welcome to New Zealand Clinical Research (NZCR), Aotearoa New Zealand’s leading early phase clinical research provider.

Join our research community, help us research new medicines, advance global health and be paid for your involvement. You will be cared for by our expert research team at every step of your clinical trial journey.

NZCR is New Zealand’s leading and most experienced researcher of new medicines.

Our expert research team have conducted over 750 clinical trials involving more than 15,000 New Zealanders.

All our trials are approved by New Zealand regulatory authorities and take place at our state-of-the-art research facilities in Auckland and Christchurch, with satellite sites in Hamilton and Wellington. Our team ensure you are fully informed, and your safety is paramount.

What does a Screening Test involve?

What's it like to Participate in a Study?

Who do we need to join our research community and help us with our research?

We need healthy people who do not take any regular medications and meet BMI (body mass index) and weight criteria. Participants need to be able to stay overnight at our research facility and attend clinic visits.

Sound like you? How to get involved…

First off we need you to register your interest; this will allow us to match you to a trial.

How to Participate in our Clinical Trials

To take part in an NZCR trial, we need you to register your details with us. This will ensure we are providing you with information on a trial that might suit you. All our trials have height, weight, BMI and other criteria in the trial. Once you have registered on our database, we will review your profile and send you information on a suitable trial, why it is being conducted, when it is taking place and the payment you will receive for taking part in the trial.

Clinical Trials going on in your area now

We have trials researching a wide variety of potential new medicines which involve varying overnight stays and follow up visits at our clinics.

Select your prefered location

• Auckland/Hamilton

Christchurch

Azure part f.

Requirements:

• Aged 18 – 65 years
• Are in good health
• BMI 18.5 – 32.0 kg/m2
• Non-smokers
• Not taking any regular prescription medications (e.g anti-depressants)

Study Visits:  3 night stay + 1 phone call

Reimbursement:  $2,500 (less tax)

AZURE PART F CHC

Why participate in a clinical trial.

Your participation will help us research new medicines which may change the lives of patients in New Zealand and around the world.

Join our research community, get a free health check-up and meet other like-minded people who want to make a difference.

While you are at an NZCR facility, you can enjoy unlimited free WiFi so you can stay in touch with your networks or work if you like. We have areas to work and play with work stations and activities like PS5 and Netflix. Plus a variety of balanced and delicious meals – including vegetarian options.

Take part in our recreational activities and space to socialise and relax. As some participants say – “it’s like a paid holiday”.

Be a part of advancing medicine and improving patient care by participating in our clinical trials today.

Helpful FAQs

A clinical trial is a scientific trial that involves people.  A clinical trial investigates whether a medicine is safe and effective for the treatment of a disease or medical condition. They are conducted by pharmaceutical and biotechnology companies in collaboration with independent investigators (our research doctors).

Results from clinical trials can be used to make new medicines available for patients worldwide.  Clinical trials can involve “healthy participants” and patient populations.

There are several phases in clinical trials.

• Phase 1: Focuses on the safety of the medicine.
• Phase II: Focuses mostly on the effectiveness of the trial medicine in treating the intended disease.
• Phase III: Focuses on safety, effectiveness and determining the right dose to treat the disease.

All NZCR trials are approved by New Zealand regulatory authorities.

• Before agreeing to participate in the trial, participants need to read the participant information sheet and understand what participation in the trial will involve.
• Our staff discuss the trial over the phone to check your eligibility (i.e., if you are suitable for the trial) in a pre- screening phone call.
• If suitable you attend our research facility to meet our medical team who will answer any questions you have, undertake medical tests e.g., blood, urine and other trial specific tests to determine your suitability to take part in the trial.
• If you decide to take part in the trial, you will be asked to sign a consent form.
• This is called Informed Consent. By signing the Consent Form trial participants are agreeing to participate in the trial.
• Participation in clinical trials is voluntary – you can withdraw from the trial at any time. Please note it is important for safety reasons that trial participants attend all the clinic visits as prescribed by the trial staff.

To ensure participant safety, all clinical trials conducted in NZ must be approved by the appropriate regulatory authorities. There is always some risk associated with taking any medicine and there will be an additional risk in taking any new medicines. There is no way to predict how an individual may react to any medication. Health risks and side effects are pre-determined during pre-clinical and early clinical trials, side effects can differ from person to person. There is no way to 100% predict how a treatment will affect an individual, therefore early phase clinical trials involve many rigorous safety assessments.

What our clinical trial participants have to say

As a nursing student, I am interested in medical research. I find doing studies at NZCR is like a paid holiday. I can come in do my trial and not worry about anything else – the cooking, the dishes all get done for me! I feel very safe and well cared for by the medical team at NZCR

"Hi I’m Alex, I have done quite a few studies at NZCR. I have found the nurses and doctors to be professional and caring. The facilities themselves to be comfortable, the lounge area providing a nice place to relax. The food portions have been very large and delicious. It's a great way to support my studying without having to take out a student loan."

This my 2nd trial and it’s a long one (16 days). The hardest part is maybe getting a needle in my arm for a blood test. Otherwise, its like a retreat. I have a lot of time for study, reading & light exercise. I am fed well and enjoy talking and the nurses or other participants.

Jun Jie has completed five clinical trials at NZCR. Here’s what Jun Jie had to say - Read more

Get in touch today

New Zealand Clinical Research (NZCR) provides state of the art research facilities and the expertise to conduct complex early phase clinical research in healthy participant and patient populations.

Clinical Research Associate 1

• Location: New Zealand
• Categories Clinical Monitoring
• __vacancyopjusttionswidget.opt-Business Area__ ICON Strategic Solutions
• __vacancyopjusttionswidget.opt-Remote Working __ Remote

About the role

This vacancy has now expired. please see similar roles below....

Clinical Research Associate II

Location: Auckland, New Zealand

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

• The team is highly structured and functions are very specialized, allowing you to focus solely on producing quality monitoring, building relationships with sites and taking ownership of site management
• There is a strong pipeline of studies and you will have the opportunity to monitor groundbreaking oncology trials as well as HIV, HPV and vaccine trials and work in a dynamic environment which promotes learning and versatility
• Access to advanced technologies, such as laptops and iPads , is provided. This streamlines processes allowing you to work more efficiently and for reduced report writing time meaning reports can be efficiently submitted in real time
• You will be part of an experienced and stable team which has seen huge growth and 100+ ongoing trials across Australia and New Zealand across varied therapeutic areas
• You will be joining a well-renowned sponsor program with a local reputation for having an excellent culture and offering a truly diverse and inclusive workplace
• There is a strong and passionate ICON leadership team who take a hands on approach and you will be encouraged to participate and share your ideas. The management team are supportive of career development and you will have access to external training opportunities and pathways of development

Requirements:

• At least 2 years local CRA experience in CRO/pharma is required and you will have previous experience monitoring oncology trials
• You will be based in Auckland and able to commit to travelling to sites
• Although continuous support will be provided, due to the remote nature of the role, you must be confident working autonomously to ensure delivery of expectations

Benefits of Working in ICON: Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.

Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.

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