Project Associate I

2 weeks ago

Sydney, New South Wales, Australia Avance Clinical Full time

**Project Associate | Office based (Sydney, Melbourne or Adelaide)**
***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 and have an exceptional reputation for supporting our people.

**Why should you join Avance Clinical?**
We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team & support. We've doubled in size in the last 2.5 years and have promoted over 25% of our people in the last 12 months.

**Broad Purpose**

The Project Associate I (PA I) assists the Project Manager (PM) in planning and executing projects by coordinating staff and processes to deliver projects on time, within budget and with the desired outcomes while 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 include**
- Support (from an administrative perspective) all aspects of project delivery from study inception to completion.
- Organize project system and process set-up during initiation phase of a study.
- Draft kick off meeting materials and liaise with all stakeholders to facilitate the meeting.
- Draft project plans for review by the Project Manager.
- Maintain project information in the Clinical Trial Management System (CTMS), including project milestone tracking.
- Accurately track project action items, risks, and issues.
- Organize, facilitate, and take minutes for project/study team meetings.
- Liaise with cross-functional team members to ensure good communication across each study.
- Trial Master File (TMF) document review, metadata update and management.
- Facilitate quarterly reviews of the TMF with the PM.
- Track vendor invoices, site invoices, and investigator grants payments on assigned projects.
- Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications.

**Qualifications, Skills, and Experience**
- Life science degree.
- Experience in a similar role within a CRO, Pharma company or investigator site.
- Previous experience as a Clinical Trial Assistant (or equivalent) is desirable.
- Knowledge of ICH GCP Guidelines and other applicable regulatory requirements.
- Clear understanding of the requirement to adhere strictly to client confidentiality.
- Excellent and clear written and oral communications skills.
- 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.

***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
- At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality._
- Project Associate / CTA / CRC / CRO / Life Science / Adelaide / Sydney / Brisbane / Melbourne_

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