Clinical Research Associate II, Melbourne based

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.