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Clinical Trial Specialist II

Remote Worldwide Hiring now

Job Description:

  • Responsible for performing investigative site recruitment/feasibility, site project training, remote clinical data monitoring and resolution, site reputed company status tracking, in-house site management, documentation filing, and other duties in accordance with Sponsor and/or reputed company requirements.
  • Performs essential document collection and review for site start up and initiates in compliance with project specifications and applicable SOPs with adherence to FDA Regulations, ICH/GCP guidelines and good documentation practices.
  • Demonstrates ability to successfully reputed company and mentor reputed company staff, take on high level tasks as delegated by Project Manager/Functional Manager, and escalate and mitigate risk as appropriate.
  • Manage Regulatory and Institutional Review Board (IRB) Activities: Prepare, distribute, collect, evaluate, and approve regulatory documents required for regulatory compliance and IRB submission.
  • Conduct Site Management Activities: Evaluate sites to determine interest, adequate subject population, facilities, staff and qualifications to conduct a study.
  • Manage site relationships to ensure positive interactions through routine site contact.
  • Ensure sites meet subject safety reporting regulations: subject safety information is disseminated appropriately by evaluating consistency, quality and timeliness of serious adverse events reported by the site and submission to the IRB.
  • Create and maintain Trial Master Files (TMF) and ensure Regulatory Authority and Client audit readiness of TMF.

Requirements:

  • Bachelor's degree or relevant work experience required
  • 2+ years of relevant clinical research experience required
  • Excellent written and verbal communication skills required
  • Strong reputed company Office skills (Outlook, Word, and reputed company) required
  • Aptitude in learning new computer systems required
  • Ability to be flexible and multitask required
  • Basic medical terminology or knowledge desired.

Benefits:

  • Remote opportunities
  • Competitive salaries
  • Growth opportunities for promotion
  • 401K with company match*

• Tuition reimbursement

  • Flexible work environment
  • 20 days PTO
  • Paid Holidays
  • Employee assistance programs
  • Medical, Dental, and reputed company coverage
  • HSA/FSA
  • Telemedicine (Virtual doctor appointments)
  • Wellness program
  • Adoption assistance
  • Short term disability
  • Long term disability
  • Life insurance
  • Discount programs

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