Study Coordinator (Research)

The US Oncology Network•Denver, CO

About The Position

Rocky Mountain Cancer Centers is seeking an experienced Research Study Coordinator in Denver to support clinical research and provide a positive experience for patients. The role plans, executes, and monitors complex clinical research protocols, working closely with physician principal investigators, clinical trial sponsors, and internal and external study teams. It also supports data management, clinical, and regulatory research teams and helps ensure adherence to protocols and preparation of study data and reports.

Requirements

  • Associate's degree required.
  • At least 3 years of research experience on interventional trials.
  • Must provide proof of influenza vaccination upon commencing employment; exemption requests will be considered case by case in accordance with applicable law.
  • Must pass a background check and non-federal drug test, excluding marijuana, after an offer and before hire.

Nice To Haves

  • Bachelor's degree preferred.

Responsibilities

  • Assist with execution of highly complex clinical trials, including protocol management and support for data management, clinical, and regulatory research teams.
  • Assist with training new Study Coordinators and Data Coordinators.
  • Develop improvements, tools, processes, and forms to enhance research department efficiency and quality.
  • Plan and track assigned clinical activity throughout study startup, interim, and closeout phases.
  • Update clinical teams on protocol modifications and specifications, including visit schedules, assessment windows, dose modifications, and central and local laboratory assessments.
  • Create and maintain study-specific source documentation tools, checklists, and clinic information documents, updating them as needed for amendments and study changes.
  • Participate in monitor visits for assigned trials as needed.
  • Review and comment on follow-up letters.
  • Assist with reviewing trial data and responding to queries.
  • Provide required study metrics to leadership.
  • Assist with physician oversight by providing updates on protocol issues.
  • Assist with sponsor and FDA audit preparation.
  • Assist with reviews and responses to monitoring and audit findings.
  • Participate in sponsor meetings as assigned.
  • Follow professional standards and clinical research SOPs.

Benefits

  • Health, dental, and vision plans
  • Wellness program
  • Health savings account
  • Flexible spending accounts
  • Potential research bonus depending on department financials after one year of employment
  • 401(k) retirement plan
  • Life insurance
  • Short-term disability insurance
  • Long-term disability insurance
  • Employee Assistance Program
  • PTO
  • Holiday pay
  • Tuition reimbursement
  • Employee-paid critical illness and accident insurance
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