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Clinical Research Associate II (CRA2)

Covance - Melbourne, Australia

11/17/2017 7:44:21 PM
15686
Clinical Research Associate


Job Overview

Are you an exceptional Senior Clinical Research Associate (SCRA) based in Sydney or Melbourne, Australia that has independent trial site monitoring Experience and would like to Experience working at a client site while remaining an employee of Covance?

Our Flexible Solutions Clinical Research Associates manage all aspects of study site monitoring according to Client SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.

Responsibilities include:

* Study startup which include IRB/IEC submission, site selection, recruitment of potential investigators, notifications to regulatory authorities, translation of study-related documentation
* Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
* Study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
* Site management as prescribed in the project plans
* Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
* Independently perform Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
* May support in organization of meetings and other tasks as instructed by supervisor

Requirements:

* Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

* Excellent understanding of Serious Adverse Event (SAE) reporting

* Typically 2+ years of clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
* Knowledge of the Australia/ NZ site and regulatory environment is beneficial

Covance Australia is committed to providing Clinical Research Associates; the flexibility to work from home, the freedom to grow careers across all phases and areas of clinical trial operations as well as provide cutting edge technology and processes that help to manage time and workload.

About Covance:

Covance is one of the world's largest and most comprehensive drug development services companies, with more than 13,000 employees in 60 countries. We began operations Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Why Covance?

At Covance, you will join like-minded collaborative professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.

Discover your potential in a company that truly invests in you. Talk to us to learn more and explore your career. Apply online today.

Education/Qualifications

* University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
* In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research Experience in pharmaceutical or CRO industries may be considered
* Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
* Thorough knowledge of monitoring procedures
* Basic understanding of the clinical trial process

Experience

* Typically two (2) years of clinical research Independant onsite monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits)

* Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
* Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
* Good planning, organization and problem solving abilities
* Ability to work with minimal supervision
* Good communication and interpersonal skills
* Good analytical and negotiation skills
* Computer competency
* Fluent in local office language and in English, both written and verbal
* Works efficiently and effectively in a matrix environment
* Experience monitoring and managing Australia based clinical trial sites strongly preferred.


Position Type: Full-Time

Location: Melbourne, AUS - Australia






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