Clinical Research Project Assistant

4 weeks ago

Melbourne, Australia GenesisCare Full time

At GenesisCare we want to hear from people who are as passionate as we are about innovation and working together to drive better life outcomes for patients around the world.

Your life’s best work

GenesisCare has an exciting opportunity for a Clinical Project Assistant to join our team, this role can either be based in Sydney or Melbourne.

As a Clinical Project Assistant at GenesisCare CRO, you will play a vital role in supporting the efficient and effective management of clinical research projects. Working closely with the Project Management and Clinical Operations team, you will contribute to the successful execution of clinical trials by providing administrative, logístical, and operational support. This role offers an excellent opportunity for individuals seeking to enter the clinical research field or further develop their career within a dynamic CRO environment.

On offer is a permanent full-time position, working Monday-Friday.

More specifically, you will:

- Support Clinical Project Managers and CRAs on project level administrative tasks. May support other cross functional teams administrative tasks as needed. Assist in the coordination and implementation of clinical trial activities according to project timelines, ensuring compliance with regulatory requirements, standard operating procedures (SOPs), and study protocols.
- Manage meeting agenda and meeting minutes preparation for project team meetings and other functional meetings.
- Generate regular project status reports as required for assigned studies.
- Work in conjunction with Clinical Project Managers to formulate and maintain a project-specific training matrix.
- Support Project Mangers in the tracking, measurement, and evaluation of project metrics to implement efficiencies.
- Prepare and collect essential study documentation in conjunction with CRAs and PMs during start up phase and maintain collection of documentation during study.
- Drive the development, printing, shipping, and tracking of Investigator Site Files.
- Support Clinical Project Manager in project finance including maintaining project finance trackers and manage monthly invoicing activities, including tracking expenses, generating invoices, and reconciling payments, ensuring accuracy and timeliness in financial transactions.
- Coordinate site payments, including tracking payments, resolving payment discrepancies, and ensuring timely and accurate disbursement of funds to clinical trial sites.
- Manage Trial Master Files (TMF) inspection readiness during set up, maintenance, issue follow up, review, and archival.
- Support in the maintenance of accurate and up-to-date project documentation in TMF.
- Assist Project Managers with TMF audits and formulates recommendations for missing components.
- Collaborate in project maintenance of Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF).
- Assist with the planning and creation of client and investigator meetings and related materials, as required.
- Assist in the coordination of activities with external vendors, such as central laboratories, clinical supplies vendors, to ensure timely delivery of services and materials.
- Assist with any other project related tasks as required

We’re interested in hearing from people who:

- Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals)
- At least two years’ experience in a clinical research setting, with experience in a CRO preferred.
- Experience in CTMS and eTMFs is desirable.
- Understanding and practical knowledge of ICH-GCP requirements is preferred.
- Strong organizational skills with meticulous attention to detail.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Office suite (Word, Excel, PowerPoint, Outlook).
- Ability to work effectively in a fast-paced, team-oriented environment.
- Able to work in an international environment with internal & external team partners (including virtual teams) is desirable.

Benefits of joining our team:

- Working with a vibrant team aligned with providing the best patient experience possible and outcomes.
- Internal and external training and development opportunities.
- Close knit internal community.
- All employees and their family members have access to free confidential support that is completely external to GenesisCare including financial, nutritional and wellbeing coaching, legal advice & counselling.
- Free access to thousands of LinkedIn training courses.
- Range of benefits available: Qantas membership discount, gym membership discount, 12 weeks paid parental leave, Bupa discount.

About GenesisCare

We are 1,300+ highly trained healthcare professionals and support staff in Australia designing innovative treatments and care for people with cancer. Our dedicated teams treat more than 30,000 patients annually.

People centricity is at the heart of what we do whether that person is a patient, a referring doctor, a partner or someone in our team

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