Covance Clinical Research Associate II in Buenos Aires, Arkansas

Job Overview

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; liase with vendors; and other duties, as assigned.

General On-siteMonitoring Responsibilities

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

Prepare accurate and timely trip reports

Undertake feasibility work when requested

Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor

Negotiate study budgets with potential investigators and assist Covance legal department with staetements of agreements as assigned

Complete SAE reporting, process production of reports , narratives and follow-ups of SAEs

Independently perform CRF review, query generation and resolution againstestablish data review guidelines on Covance or client data management systems as assigned by manageament

Assist with training of new employees, e.g. co-monitoring

Coordinate designated clinical projects as local project coordinator ( with supervision) and may act as local client contact assigned

Perform other duties as assigned by management

Education/Qualifications

Minimun Required:

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

AND

  • a minimum of 2 years of Clinical Monitoring experience

Experience

Minimun required:

  • UNiversity or college degree or certification in a related allied health proffession

AND

  • a minimun of 2 years of Clinical Monitoring Experience

  • Ability to Monitor study sites independently according to the protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

  • Have a full understanding of a Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

  • Good planning, organization and problem solving abilities

  • Good communication and interpersonal skills

  • Good analytical and negotaiation skills

  • Computer competency

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

  • Work efficiently and effectively ina matrix enviroment

Preferred: One or more additional years of experience ina related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writting) is preferred

Job Number 2018-20319

Job Category Clinical Research Associate

Position Type Full-Time

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.