Clinical Research Associate II, Melbourne based

3 weeks ago

Melbourne, Victoria, Australia Fortrea Full time

Join to apply for the Clinical Research Associate II, Melbourne based role at Fortrea

Clinical Research Associate II, Melbourne based

Join to apply for the Clinical Research Associate II, Melbourne based role at Fortrea

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As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 15,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Fortrea CRAs Enjoy

Working on cutting edge global clinical trials
Have experienced & supportive managers to help grow CRA knowledge and skills
Career development opportunities
Opportunities to work for dedicated sponsors (FSP) and full service (GCD)

Your Responsibilities Include

Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
Responsible for all aspects of site management as prescribed in the project plans
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
Monitor data for missing or implausible data
Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy
Ensure audit readiness at the site level
Travel, including air travel, may be required and is an essential function of the job.
Prepare accurate and timely trip reports
Interact with internal work groups to evaluate needs, resources and timelines
Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
Responsible for all aspects of registry management as prescribed in the project plans
Undertake feasibility work when requested
Participate in and follow-up on Quality Control Visits (QC) when requested
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned 18) Assist Senior CRA with managing investigator site budgets
Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
Assist with training, mentoring and development of new employees, e.g. co-monitoring
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned

About You

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
Demonstrated experience in onsite monitoring from SIV to Close-out
Understanding and experience in Australian Regulatory Guidelines
Happy to split time between the office and home (Hybrid)

Learn more about our EEO & Accommodations request here.Seniority level

Seniority levelEntry level

Employment type

Employment typeFull-time

Job function

Job functionResearch, Analyst, and Information Technology

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