In-house Clinical Research Associate (BB-6FE2A)
Found in: Neuvoo AU
Are you ready to step up and discover your extraordinary potential at Covance?
A career here provides the unique chance to create a lasting impact and difference in our patient’s lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy & collaborative work place, along with access to comprehensive benefits. Your work will be meaningful, the patient outcomes are real, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.
Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.
As an Inhouse Clinical Research Associate you will:
Serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.Assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.Assist with the coordination of study visits and shipment of drug and laboratory samples.Manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.Liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.Liaise with the CTA to assist the Project Team in the production of Status Reports.Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability).Perform remote visits (i.e. Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan, but does not perform remote monitoring that requires SDV.Perform visits either as the primary monitor or the comonitor as required by the monitoring plan to include those indicated in the chart below. For visits that require direct supervision, the following staff is qualified to supervise the In House CRA Clinical Research Associates I and 2, Sr. Clinical Research Associates, Clinical Trial Leads, Project Managers or Project Directors.Undertake other project related administrative tasks (i.e. meeting minutes, recruitment tracking, site document preparation) as appropriate, as assigned by the project Manager and CTL,Might be requested to work in a client facing environment
So if you are ready to move your career forward to become an independent Clinical Research Associate in future whay not apply today!
Education/Qualifications:University or college degree in a life science subject, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure) Experience:Typically a minimum of 2 years of experience within Australia and a related role (e.g. site management, study coordinator, research nurse, etc.)Understanding of ICH Guidelines and GCP including a basic understanding of Australian regulatory and TGA requirements Understanding of the clinical trial process Valid Driver’s License Able to travel interstate up to 60% of the time Happy to be office based in Sydney or Melbourne
calendar_today19 hours ago
work Laboratory Corporation of America Holdings (Covance)