Clinical Research Associate II

Research AnalystResearch AnalystFull TimeRemoteTeam 1,001-5,000H1B No SponsorCompany SiteLinkedIn

Location

Florida + 2 moreAll locations: Florida, North Carolina, South Carolina

Posted

20 hours ago

Salary

$91.5K - $137.3K / year

Bachelor Degree2 yrs expEnglish

Job Description

• Oversees all aspects of study site management to ensure patient safety is protected. • Provides guidance at the site and project level towards audit readiness standards. • Updates, tracks and maintains study specific trial management tools/systems, and status reports. • Manages site start up procedures including feasibility and recruitment of potential investigators. • Assists the negotiation of study budgets and the execution of investigator contracts. • Verifies the process of obtaining informed consent has been adequately performed and documented. • Independently conducts all forms of site visits. • Documents activities via confirmation letters, follow-up letters, trip reports. • Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management. • Develops and maintains good working relationship with investigators and study staff. • Performs investigational product (IP) inventory, reconciliation and reviews storage and security. • Performs data review activities, including remote EDC CRF and patient profiles review. • Identifies and processes Serious Adverse Events according to the procedures defined by the study team. • Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies.

Job Requirements

  • 4-year college degree or equivalent experience in a scientific or healthcare discipline.
  • Two (2) years or more as a CRA in a CRO or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research
  • Excellent communication and organizational skills are essential. A team player.
  • Evidence of a client focused approach
  • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.
  • Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed.
  • Fluency in English and for non-English speaking countries the local language of country where position based

Benefits

  • paid time off
  • volunteer time off
  • robust medical offerings
  • non-vested 401k plus company match
  • paid parental leave

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