Senior Clinical Research Associate I

Job Overview:

We are seeking an exceptional Senior Clinical Research Associate to join our extraordinary people in our clinical operations team that monitors Phase I - IV clinical trials.

Covance Senior Clinical Research Associates: Lead all aspects of study site monitoring according to Covance/Chiltern SOP, GCP, and ICH guidelines Partner with investigators and study coordinators on pre-study qualification and site initiation visits Conduct routine study site monitoring visits Close-out clinical sites, and ensure study files are up to date to maintain the success of the study.

If you are passionate about Clinical Research and a person who has experience independently monitoring Phase I - IV clinical study sites in Australia, let’s talk as we may have a job for you.

Covance Australia is committed to providing you the flexibility to work from home, the freedom to grow & develop your career across all phases and areas of clinical trial operations, as well as provide state of the art technology and processes that help to give you time back to enjoy family life.

You will join like-minded collaborative professionals at Covance 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.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Education/Qualifications:

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)

• In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered.

• Thorough knowledge of regulatory requirements

• Thorough understanding of the drug development process

• Fluent in local office language and in English, both written and verbal

• Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job

 Experience:

Minimum Required:Two (2) years of Clinical Monitoring experienceHave a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEsAdvanced site monitoring skillsAdvanced study site management skillsAdvanced registry administration skillsAbility to work with minimal supervisionGood planning and organization skillsGood computer skills with good working knowledge of a range of computer packagesAdvanced verbal and written communication skillsAbility to train and supervise junior staffAbility to resolve project-related problems and prioritizes workload for self and teamAbility to work within a project teamWorks efficiently and effectively in a matrix environmentValid Driver's License

Preferred:One (1) or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferredLocal project coordination and/or project management experience