DATAPHARM AUSTRALIA – Datapharm is Australia’s original local Contract Research Organisation (CRO) (est.1987) that provides a one-stop shop for overseas and local sponsors conducting Clinical Trials in Australia. Our clinical team supports study set up as well as site monitoring. Datapharm also supports clinical data management, statistical programming, medical writing and pharmacovigilance.

We are looking for Clinical Research Associates (CRAs) to join our team at all levels:

If you have over 2 years’ experience as a CRA or SCRA you may be ready to take on a Project Lead role.

If you have some experience as a CRA or SCRA, you may wish to start traveling again or you may prefer a regional monitoring role.

We are also looking for Entry Level CRAs who wish to start their career in clinical research.

We will also consider hybrid roles eg Medical Writer which may suit applicants with higher degrees.

Qualifications:

• Degree in life sciences (eg science with pharmacology, medical science, pharmacy, medicine, nursing..)

Desirable:

• Training in ICH GCP and local regulatory requirements for clinical trials.
• Previous experience as CTA or CRA.

What do CRAs do?

• Conduct all aspects of monitoring of a clinical trial according to ICH GCP requirements including on-site Pre-Study Visits (PSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs), Remote monitoring and other aspects of site support, trial documentation, maintaining the Trial Master File (TMF), liaison with sites and reporting to the trial sponsor.
• Support study start-up activities including site selection, HREC applications, CTN submissions, collecting essential documents, site budgets and CTRA, register study on ANZCTR.
• You will also manage regular site liaison, tracking, query resolution, and maintaining investigator site file and TMF.
• You may need to travel interstate for site visits or conduct on site monitoring visits locally if you are in a regional position.
• While COVID restrictions are in place you may be working from home and conducting remote visits.
• You will also participate in reporting to the sponsor and liaison with sponsor and team members in calls, Zoom and face-to-face meetings and in-house team meetings.
• You may write agendas and minutes for meetings.
• You may write the monitoring plan and check manuals that will be used at the study site.

About you:

• You have a real interest in science and clinical research.
• You have strong analytical skills to problem solve and resolve issues as raised by sites or the sponsor.
• You are a confident communicator and like to be well-prepared for meetings, visits, presentations and calls.
• You are efficient and clear in writing reports and meeting minutes.
• You like to meet deadlines and have an enthusiastic ‘can-do’ attitude.
• You take responsibility in the quality and outcomes of your work.
• You work well in a project team and respect other team members
• If you are an experienced CRA, you would be happy to learn project management skills to take on more responsibilities to manage the overall conduct of some of your studies.

About Datapharm Australia:

• Established 1987 we are the original Australian privately owned CRO.
• We have a rather unique versatile team and a family friendly culture
• There are opportunities within Datapharm to learn new skills and also to grow by untapping your hidden talents to try new roles and responsibilities.
• Our head office is in Sydney however we have clinical team members located in regional positions and are happy to consider applicants residing in other states.

Other:
You must have the right to live and work in Australia to apply for this job.
Datapharm reserves the right not to proceed with any appointment.

Salary:
Salary will be negotiated according to experience and qualifications.