Study Lead, Feasibility Coordinator
Location
Tennessee
Posted
3 days ago
Salary
0
Seniority
Senior
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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