John Hopkins University

Clinical Research Site Manager

John Hopkins University

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $55,800 - $97,600 per year

Job Level

Mid-LevelSenior

Tech Stack

Google Cloud Platform

About the role

  • Deliver to and organize work plans with 20+ collaborating clinical sites across the country supporting clinical trial research goals.
  • Train and manage clinical and data entry personnel at centers regarding trial metrics and protocol fidelity.
  • Oversee regulatory compliance, IRB submissions, and site activation documentation.
  • Oversee site performance, assist with eligibility and randomization, and remediate recruitment issues.
  • Conduct weekly teleconferences and monthly training broadcasts; mentor coordinators and investigators.
  • Provide support to quality assurance monitors and manage site investigator relationships.
  • Execute lean management processes to ensure on-time, within-budget site delivery and high-quality standards.
  • Perform self-audits and audit clinical sites; recommend operational changes.
  • Track proposals through signature/approval processes and collaborate with contracts and IRB Navigators.
  • Use data and statistical analysis to drive decision making and help investigators understand performance data.
  • Develop SOPs and assist in auditing and monitoring study sites.
  • Build and maintain strong relationships and embrace clinical research technology innovations.

Requirements

  • Bachelor's Degree required in related field.
  • Five (5) years’ experience in delivering effective clinical research management solutions.
  • Additional education may substitute for required experience per JHU equivalency formula.
  • Preferred: Minimum of two years direct project management.
  • Preferred: Knowledge of formal project management methodologies.
  • Preferred: Experience in academic medicine environment.
  • Preferred: Experience representing trial policies and communicating scientific concepts
  • Must possess excellent negotiation, facilitation, consensus-building, and diplomacy skills.