Clinical Trial Associate I

3 weeks ago

North Sydney, Australia Avance Clinical Full time

**Who are we?**
We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.

**Why should you join Avance Clinical?**
We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.

We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

**The role**
The Clinical Trial Associate I (CTA I) is responsible for supporting the Clinical Operations Team in an administrative capacity ensuring the trial is conducted in accordance with the protocol, company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements

**Core Responsibilities**
- Support all aspects of clinical operations from study inception to completion, including:

- Organise, facilitate and take minutes for project/study team and functional group meetings.
- Establish, maintain and track completeness of Trial Master Files.
- Prepare Investigator Site Files and establish study documentation for assigned studies as required. o Liaise with study team members to ensure good communication across each study.
- Prepare and collect site documentation in conjunction with Project Manager and Clinical Research Associate, from study start up through to end of study.
- Manage receipt and shipping of study documentation to Investigator sites, maintain internal trackers.
- Maintain internal databases and assist the Clinical Operations team in ad hoc duties.
- Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
- Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.

**Qualifications, Skills and Experience**
- Bachelor’s level degree in life sciences, pharmacy, nursing or equivalent field (highly regarded), or appropriate industry experience.
- Previous exposure to a Clinical Trials environment (desirable).
- Awareness of ICH GCP Guidelines and other applicable regulatory requirements (desirable).
- Clear understanding of the requirement to adhere strictly to client confidentiality.
- Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.
- Demonstrated ability to take initiative in problem solving and in exercising good judgment.
- An understanding of Privacy Legislation as it applies to the Clinical Trial Environment (desirable).
- Ability to work under pressure in a multi-disciplinary team environment.
- Willingness to work in, and be supportive of, a positive and dynamic team culture.
- Ability to travel (desirable). Very mínimal level of travel may be required (up to 10%).

**What we offer**
- Stimulating work
- Project diversity
- An intellectual challenge
- An agile & flexible workplace
- Opportunity to progress
- Stability
- Sense of community
- A leadership team that are working together on a common goal
- Flexible work options
- Great tools / tech to do your job
- A competitive salary & an extra days holiday for your birthday

**What next?**
As a growing business we’re looking for likeminded people to join us - we hope that’s you.
- To join our team please submit your CV & cover letter as one Microsoft Word document
- You must have full Australian working rights to be considered

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