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Clinical Trial Specialist

Clinical ResearchClinical ResearchFull TimeRemoteMid LevelTeam 501-1,000Since 2000H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

63 days ago

Salary

$60K - $90K / year

Seniority

Mid Level

Associate Degree2 yrs expExperience acceptedEnglishGoogle Cloud Platform

Job Description

Clinical Trial Specialist

Emerald Clinical

• Increase proficiency in Trial Master File (TMF) set-up and maintenance (filing), both hard copy and electronic as assigned by project. • Increase proficiency in uploading and maintaining TMF files and folders in George Clinical’s file-sharing system by project as assigned. • Serve as second reviewer for TMF QC. • May function in the TMF Lead Role and assume responsibility for TMF setup, maintenance and oversight. • Assist with/complete end of study TMF filing (including site close out documents), QC and archival. • Further develop skills in preparing and participating in audit responses. • Perform QC of work (documents, emails etc.) prior to sending out to ensure quality product deliverables. • Further develop skills and knowledge of data entry and maintaining files/folders for Clinical Trial Management System by project as assigned. • Further develop skills and knowledge of assisting with data entry support, tracking and submission for investigator payments by project as assigned. • Works with CRA/CTM/PM during site start-up for feasibility, serving as point of contact for sites where applicable. • Assist with presenting final feasibility results to PM team and/or Sponsor. • Assists the sites in preparation, planning, organizing and collecting essential document packets (EDPs).

Job Requirements

  • College / University diploma / degree; OR at least 2 years related experiences and / or training; OR equivalent combination of education and experience.
  • Ability to perform general administrative duties as needed or required.
  • Exposure to medical terminology preferred.
  • Knowledge of ICH/GCP, ethical and regulatory requirements preferred.

Benefits

  • Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.
  • Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.
  • Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
  • Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
  • Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.

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