Covance

Clinical Research Assoc. I MEA

Job Location(s) AU-Melbourne
Job Number
2020-50555
Job Category
Clinical Research Associates
Position Type
Full-Time
Telecommute
No

Job Overview

Please note this is a future opportunity!  Covance has recently promoted some of our in house team into CRA roles meaning there will be an opportunity in the future for entry level positions.  If you have previously applied there is no need to apply again.  If you would like to receive job updates and are not currently being sent them, please join our talent community.  We would love to hear from individuals who would like to start their pathway to become a CRA.  We are especially interested in hearing from study coordinators, Clinical Trial Administrator, Start up specialists and in house CRAs.  When you join Covance you will receive excellent training, both face to face (delivered in a Covid safe manner) and online.  You will have a mentor and support from some extremely experienced colleagues.
 
Essential Job Duties: ♦ 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, with or without guidance (as per the training status of the CRAI-MEA); liaise with vendors; and other duties, as assigned ♦ Responsible for aspects of registry management as prescribed in the project plans ♦ General On-Site Monitoring Responsibilities: o Assist Senior CRAs and CRA-2 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability) o Initiate, monitor and close out clinical investigative sites, with or without direct supervision from Senior Clinical Research Associates, Clinical Team Leads, Project Managers or Project Directors, as assigned based on training status and adequate skillset acquisition. On-site Routine Monitoring Visits should be accompanied by an experienced co-monitor (as per training status and agreement from Line Management). o Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study o Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements o Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review o Monitor data for missing or implausible data o Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner
 
Minimum Required: ♦ External Candidates o University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure) AND
o A minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)

Education/Qualifications

Minimum Required: ♦ External Candidates o University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure) AND
o A minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)
Final: 17 August 2016 Page 5 of 5
♦ Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements ♦ Basic understanding of the clinical trial process ♦ Valid Driver’s License
Preferred: ♦ Working knowledge of Covance SOPs for site monitoring

Experience

Minimum Required: ♦ External Candidates o University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure) AND o a minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)

♦ Internal candidates o Internal candidates with a minimum 2 years clinical trials or site management experience (e.g. study coordinator, project coordinator, project specialist, study start up) ♦ Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP ♦ Ability to work within a project team ♦ Good planning, organization and problem solving abilities ♦ Good communication skills, oral and written ♦ Good computer skills ♦ Works efficiently and effectively in a matrix environment ♦ Fluent in local office language and in English, both written and verbal
Preferred: ♦ One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical laboratory, research, data analysis, data management or technical writing) is preferred.

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