28 Jul
Clinical Research Associate - Unblinded (Western US)
Oregon, Portland 00000 Portland USA

Vacancy expired!

Job Overview:CRA - Drug Accountability (Unblinded CRA)Covance is seeking an Unblinded CRA to cover the Western Region of the US. This is a specialized CRA role which primarily focuses on drug accountability at a site level across a range of protocols and therapeutic areas. Essential Job Duties:

Responsible for all aspects of 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

Responsible for all aspects of site management as prescribed in the project plans

Travel, including air travel, may be required and is an essential function of the job.

Prepare accurate and timely trip reports

Review progress of projects and initiate appropriate actions to achieve target objectives

Organize and make presentations at Investigator Meetings

Participate in the development of protocols and Case Report Forms as assigned

Participate in writing clinical trial reports as assigned

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

Conduct, report and follow-up on Monitor Quality Control Visits (MQC) or Quality Control Visits (CQC) when requested

Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management

Education/Qualifications:

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.

Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements

Thorough knowledge of monitoring procedures

Basic understanding of the drug accountability process

Valid Driver's License

Experience:

A minimum of 1 year of Onsite Clinical Monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted.

Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory 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

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

Vacancy expired!


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