Job Overview:
We are seeking a skilled Senior Research Associate to join our team in Sydney, Melbourne, or Brisbane.
This role will be responsible for overseeing clinical trials, ensuring projects are conducted in accordance with applicable SOPs, regulations, and ICH guidelines.
The ideal candidate will possess an undergraduate degree in Life Sciences and at least 3-4 years of experience in monitoring clinical trials in a CRO, Pharmaceutical, and/or Biotechnology industry as a SCRA/CRA. Experience in managing early phase oncology trials is highly preferred.
Key Responsibilities:
* Perform Site Qualification Visits: discuss protocol, other available study documentation, and study requirements with Investigator and other trial staff
* Support feasibility, site selection, and start-up activities, including leading the preparation of Human Research Ethics Committee (HREC) submissions with sites
* Negotiate site budgets and assist with the execution of site contracts with support from the PM
* Perform Site Initiation Visits: train Investigators and other trial staff in the protocol and data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements
* Perform Interim Monitoring Visits: ensure adherence to protocol, monitor participant source data via source document verification per the monitoring plan, and perform Investigational Product accountability
* Oversee all aspects of study site management to ensure high-quality data
* Maintain eTMF filing
* Maintain study tracking in Clinical Trial Management System (CTMS) in a timely manner
* Manage timely site payments
Benefits of Joining Our Organization:
* Opportunity to own your development and learn every day
* Chance to get involved in early site engagement right from feasibility and start-up period to build relationships with sites
* Opportunity to work directly with sponsors on assigned projects
* Internal and external training and development opportunities
* All employees and their family members have access to free confidential support that is completely external to the organization, including financial, nutritional, and wellbeing coaching, legal advice & counselling
* Enhance your holistic wellbeing with our Full Circle wellbeing program
* Range of benefits available: Qantas membership discount, Anytime Fitness Gym membership discount, 12 weeks paid parental leave, Bupa discount