The Clinical Research Scientist II focuses on one or more specific scientific endeavors of laboratory and/or clinically-based research. Utilizes unique, advanced skills in clinical/population-based methodology to achieve the highest research goals. Oversees clinical research activities including interaction with researchers, clinicians, coordinators, clinical research associates, and administrators. Works with Principal Investigators to establish policies and procedures to ensure Good Clinical Practices. Develops Standard Operating Procedures (SOPs). Leads or directs related projects and supervises personnel, ensuring adequate training and compliance with proper work practices. Initiates and conducts independent research without direct supervision. Assists with the management of large, multidisciplinary research operations.

MINIMUM EDUCATION AND/OR TRAINING

• MD or PhD in relevant scientific field required.

MINIMUM EXPERIENCE:

• Minimum Requirement: 5+ substantial prior relevant and productive research experience in clinical/population-based outcomes and health behavior research.
• Experience in study design methodology, protocol development, study conduct, and analysis.
• Experience working in a project-oriented matrixed team environment.
• Proven performance in earlier role.

SPECIAL SKILLS, KNOWLEDGE AND ABILITIES:

• Shows strong skills in thinking critically with a systemic view.
• Shows expertise in taking a structured approach to analyze and resolve issues.
• Able to distinguish between different sets of issues, set priorities, and make decisions.
• 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.
• Keeps teams energized and focused on high-quality results.
• Thinks long-term in building and executing plans and stretch goals for St. Jude.
• Builds structures and processes with clear lines of authority and accountability so everyone knows what they are empowered and accountable to do.
• Identifies and applies new technologies and techniques for the quality, conduct, and safety of the clinical studies.
• Develops protocols; identifies scientific questions (hypotheses), objectives (primary & secondary), and associated endpoints.
• Evaluates study design, critically analyzes clinical study results, and proposes adjustments/changes in line with research objectives.

• Direct clinical research activities in the assigned department including, planning and prioritization of protocol activities and oversight of delivery by clinical research support personnel.
• Support management of large, multidisciplinary research operations and the instruction of research staff.
• Collaborate with Principal Investigators/Coordinators to identify, plan, and address clinical research support needs.
• Engage with cross-functional stakeholders to provide guidance around critical decisions (e.g., development of clinical research databases; protocol design & implementation; data collection systems; regulatory submissions; publication of results; equipment selection).
• Provide inputs and support to leadership to establish communication across cross-functional and external teams for clinical research objectives.
• Oversee compliance during clinical trial conduct with GCP, SOP, and protocol requirements.
• Prepare and oversee analyses, related records, and statistics for clinical research activities.
• Present/publish results, insights, and outcomes both internally and externally to multi-disciplinary audiences.
• Train, mentor, and guide team members and ensure they have all the resources required, to complete their assigned tasks.
• (As applicable) Engage in hiring, performance management, and other people processes.