Job Responsibilities:

• Assist in development and management of clinical research protocols for multiple disease teams in compliance with regulatory requirements (e.g., data collection and reporting, record maintenance and communication, protocol issue resolution, IRB engagement).
• Participate in set-up, planning, maintenance, and close-out of both single and multi-institutional national and international clinical trials.
• Track and oversee documentation, study status and key milestones within CTMS, eTMF, and other systems and applications as needed.
• Utilize tools, metrics, and reports as part of the full study management lifecycle.
• Serve in an advisory role for development of institutional and NIH (National Institutes of Health) grants.
• Act as a liaison between the Principal Investigators (study teams), internal bodies (e.g., CTO, CTSRC, IRB), and external bodies (e.g., FDA, NIH, pharmaceutical firms).
• Develop, implement, and maintain standard operating procedures and business processes for conduct of clinical protocols.
• Mentor and guide team members and ensure timely resource availability for accomplishment of outcomes.
• Track resource allocations and act as an escalation point for both study and staff-related issues.
• Engage in hiring, performance management, and other people processes.
• Perform other duties as assigned to meet the goals and objectives of the department and institution.
• Maintains regular and predictable attendance.

Minimum Education and/or Training:

• Bachelor's degree in relevant area required.

Minimum Experience:

• Minimum Requirement: 6+ progressive years of experience in a relevant comparable clinical research operations area including experience managing at least 1-2 people preferred.
• Experience working with Cl. Res. Ops. systems/processes and their maintenance/implementation, as applicable to own area.
• Significant technical experience in area (e.g., research monitoring, regulatory documentation, etc.).
• Significant experience working with relevant regulations and guidelines (e.g., Good Clinical Practice Guidelines, Office of Human Research Protections review and reporting requirements), and supporting institutional compliance.
• Extensive experience leading projects/processes end to end including resource planning and management, and communication and collaboration with internal cross-functional teams and external partners preferred.
• Proven performance in earlier role.

Licensure, Registration and/or Certification Required by Law:

• None

Licensure, Registration and/or Certification Required by SJCRH Only:

• None

Special Skills, Knowledge and Abilities:

• Ability to think critically, draw insights and connect the dots. Openness to change and adapting to changing times with resilience and flexibility.
• Demonstrates strong knowledge/skills within area on a consistent basis to solve complex problems independently
• Able to draw insights from different sets of data and quickly understand why issues are happening. Solves problems quickly by identifying the root causes. Encourages others to see the opportunities ahead amidst changing circumstances even when the details have not been finalized.
• Skills in communicating complex ideas effectively to diverse audiences and influence others to see different points of view.
• Leverages advanced knowledge/ skills within area to identify and implement new/improved processes/approaches
• Can present/facilitate independently in senior-level meetings. Presents information as a structured story and anticipates questions well. Addresses difficult questions and challenges effectively. Able to effectively influence others using facts and logic.
• Focus on setting high targets, following through with actions, and achieving results. Ability to anticipate roadblocks and circumvent challenges.
• Keeps teams energized and focused on high-quality results. Thinks long-term in building and executing metrics-driven plans and stretch goals for St. Jude. Builds structures and processes with clear lines of authority and accountability so teams know what they are empowered and accountable to do.
• Skills in clinical data management processes/tools to source and compile data with an understanding of potential data needs.
• Learns on the job and applies skills in routine tasks and activities; delivers under supervision and guidance
• Applies basic understanding of clinical data management processes, tools, & concepts to support data sourcing and compilation for assigned studies/areas with guidance. Addresses data queries and requirements based on knowledge of origin, flow, and management of data through a clinical study.
• Knowledge of study operations and oversight; Ability to plan and manage study activities across sites.
• Assesses and ensures ICH GCP compliance throughout the conduct of clinical research studies within own area/ site. Provides input and guidance for site assessment around feasibility. Develops and implements institutional DSMP and study-specific monitoring plans across sites and studies.
• Skills in managing people, establishing goals and objectives, giving feedback and having frequent career conversations.
• Is able to apply knowledge/skills within own area to deliver tasks with limited guidance
• Able to deliver results through others by setting stretch goals and holding them accountable. Coaches team members with concrete feedback and improvement ideas, including addressing employee relations concerns. Explores opportunities for development of direct reports that makes their work enriching, empowers them, and stretches their growth in lateral areas.
• Knowledge of regulatory, safety, and/or human subject protection considerations in relation to product development and/or clinical trial conduct.
• Applies knowledge of regulatory aspects related to investigational product development, protocol approval, and/or risk assessment processes. Supports regulatory compliance and documentation during study design and conduct across phases throughout the development life cycle. Understands, interprets, and guides application of relevant regulatory laws and safety and ethical requirements across clinical research teams.