Study Lead, Feasibility Coordinator

GeneralGeneralFull TimeRemoteSeniorTeam 10,001+Since 1833H1B SponsorCompany SiteLinkedIn

Location

Tennessee

Posted

3 days ago

Salary

0

Seniority

Senior

Associate Degree3 yrs expEnglishVault

Job Description

Study Lead, Feasibility Coordinator

McKesson

• Owns the operational execution of feasibility - ensuring surveys are launched, tracked, and analyzed efficiently while supporting Study Leads with data, site coordination, and timeline management to drive informed site selection • Serves as a point of contact for internal Sarah Cannon departments, physician leaders and staff at SCRI strategic sites, Contract Research Organizations, and pharmaceutical companies for feasibility • Consults with study team members on key feasibility questions for clinical trials • Builds feasibility survey within system, launches feasibility to sites recommended by therapeutic development and lead management, tracks site responses, follows up with non-responders and documents within systems • Creates and maintains training for INSITE feasibility process and reviews SOP and/or work instructions • Works with research site operations to make sure site capability spreadsheet is updated due to site responses to feasibility • Tracks and enters numerous data points within Veeva Clinical, Veeva Site Connect, Veeva Site Vault and USON CTMS • Creates and maintains Veeva CLR Vault for Clinical Review Process • Creates initial Veeva Site Connect and Veeva Site Vault for all SCRI sites • Hosts call, sends out agenda and minutes to members of the team • Creates and shares feasibility metrics/reports with leadership • Ensures the appropriate stakeholders are informed of key site feasibility changes and issues are escalated to stakeholders appropriately • Adheres to professional communication standards and SOPs for feasibility • Serves as backup to study coordinator 2 with lead management inbox • Other special projects as needed

Job Requirements

  • Associate's Degree or equivalent experience
  • 3+ years of experience in clinical research
  • Experience with CTMS, eTMF, and Smartsheet required
  • Certified clinical research coordinator, clinical research professional or clinical research associate preferred
  • Understand clinical research process and clinical trial lifestyle
  • Understand clinical and site logistics, as well as startup and site activation
  • Knowledge and/or experience in pharmaceutical industry, regulatory process, clinical trials and medical terminology
  • Disciplined and proactive way of thinking in which individuals consistently evaluate processes, decisions, and outcomes through the lens of quality.
  • Ability to meet critical time-sensitive objectives and work with a sense of urgency
  • Ability to read and understand basic protocol and feasibility questions and how they impact SCRI sites
  • Problem solving skills in fast-paced environment
  • Interpersonal skills and detailed-oriented

Benefits

  • Comprehensive benefits to support physical, mental, and financial well-being
  • Competitive compensation package determined by performance, experience, skills, and geographical markets

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