Manager, Clinical Research Education

OneOncologyNashville, TN
1d

About The Position

The Clinical Research Education Manager is a transformational leader who guides Clinical Research Education with strategic design, implementation, and oversight of education, onboarding, and competency programs for all clinical research staff. This role ensures that Research staff are consistently trained, competency-validated, and compliant with GCP, FDA regulations, sponsor requirements, and organizational policies. This position serves as a critical bridge between clinical operations, regulatory compliance, and workforce development, supporting high-quality research conduct, audit readiness, and staff retention across all research sites. The manager collaborates closely with the Director of Education Services and Director of Research, and other stakeholders to foster a positive team culture, expand training and education, measure program outcomes, and drive program excellence.

Requirements

  • Strong understanding of clinical research operations and the systems as it relates to organizational functionality.
  • Serves as subject matter expert for Clinical Research roles and requirements.
  • Ability to communicate professionally and effectively by phone, in person, or through correspondence, also includes presentations and public speaking opportunities.
  • Ability to create an environment that encourages innovation, values continuous learning, and uses modern learning experience tools.
  • Ability to monitor/assess performance of self, staff, or organization to recommend improvements regarding workflow, processes, and procedures.
  • Ability to demonstrate active listening, by giving full attention to what other people are saying, taking time to understand the points being made, and asking questions as appropriate.
  • Ability to identify complex problems and apply sound decision-making processes to recommend and implement solutions.
  • Identify measures or indicators of team performance and the actions needed to improve or correct performance, relative to the goals of the team.
  • Skilled in adapting to new and/or changing environments, supporting innovation, and driving change.
  • Ability to establish priorities and coordinate the work activities of multiple team members.
  • Ability to manage multiple tasks and meet deadlines in a highly active environment with a high degree of accuracy and efficiency.
  • Ability to build and maintain trusting relationships including management of confidential or sensitive information.
  • Ability to be proactive, self-motivated, and self-directed.
  • Ability to travel to clinic locations required.
  • Bachelor’s degree required; Master’s preferred.
  • 3 years of Research experience required.
  • 2-3 years of healthcare management required.
  • Recent experience with staff education required.
  • ACRP-CP, CCRP, or equivalent research certification required within 6 months of hire.

Responsibilities

  • Responsible for developing and managing education initiatives for Clinical Research.
  • Guides and manages team members in all aspects of the development and implementation of education content to meet organizational needs.
  • Ensures all research staff education and training documentation supports ICH GCP guidelines, FDA regulations, Sponsor requirements, and Internal quality reviews.
  • Facilitates team communication and provides constructive coaching and direction to team members to keep initiatives moving forward to completion.
  • Utilizes adult learning principles to develop and administer education content.
  • Fosters a positive team culture to enhance job satisfaction and team member engagement.
  • Working collaboratively with leadership, identify training needs and correlate resources to fulfill requests.
  • Applies systems-thinking, problem-solving, and collaboration skills for all education/project requests to identify and minimize cross-functional or downstream impacts.
  • Serves as an internal consultant to guide the development/enhancement of workflows, policies, and standards as they relate to organizational needs.
  • Applies subject matter expertise and business analysis skills when partnering with stakeholders to define and document education/training gaps to enhance content development and refine processes.
  • Troubleshoots potential and/or current problems by engaging with stakeholders and subject matter experts and performing root cause analysis (when appropriate) to proactively address concerns and respond to issues or concerns in a timely manner.
  • Reviews training/education feedback for program improvement and team member engagement.
  • Supports project requests and any other responsibilities as determined by the Director of Education Services and Director of Clinical Research.
  • Actively supports Clinical Research functions for the organization as needed.
  • Collaborate with leadership to create and update annual education plans based on regulatory changes, audit findings, protocol complexity, and operational needs.
  • Lead education-based corrective and preventive action (CAPA) initiatives following audit findings or protocol deviations.
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