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Job Summary

Responsible for the administration of the daily operations of the Research Institute at Nicklaus Children's Health System. Directs the clinical research functions and services for the Health System. Collaborates with the Office of Sponsored Programs team, Personalized Medicine Initiative team, and other clinical research professionals to ensure clinical research and related activities are performed in accordance with all applicable federal regulations and NCHS policies and procedures.

Minimum Job Requirements

• Master's Degree Graduate level degree in a Biomedical field (Required)
• CRP - Clinical Research Professional Clinical research certification (e.g. CCRC, CCRP or CCRA)
• More than 10 years Extensive track record of accomplishment in biomedical research and/or research administration with relevant experience
• 7-10 years Experience in managing projects, leading teams, and stewarding financial resources
• Research administration experience
• Previous experience with and understanding of operational budgets.

Knowledge, Skills, and Abilities

• Doctoral degree (e.g., MD, DO, PhD) preferred.
• Expert knowledge of federal regulations governing research.
  
• Leadership qualities, involving managing diverse teams.
• Ability to set and effectively communicate priorities.
• Problem solving skills.
• Ability to interpret, adapt, and respond calmly under stressful conditions.
• Able to effectively monitor and develop the abilities of team members and other stakeholders.
• Able to relate cooperatively and constructively with a research and/or clinical group or team.
• Proficient at using logical and scientific thinking to interpret technical data and solve a broad range of problems.
• Knowledge of clinical trials management systems (CTMS) and other system business solutions.
• Ability to work as a member of a collaborative and interdisciplinary team to forward the objectives of the Research Institute.
• Ability to provide subject matter expertise on research compliance including human subjects' research, research involving animals, scientific misconduct, research integrity, recombinant DNA, conflicts of interest, as well, as compliance related to the DoD, FDA, DEA, PHS, and its agencies.
• Highly organized, skilled administrator with the ability to manage and prioritize multiple projects and coordinate cross-discipline research projects and interdisciplinary programs.
• Ability to communicate effectively both verbally and in writing.
• Skilled communicator with effective speaking and presentation skills.
• Ability to consistently deliver a high quality of work including accuracy, timeliness, professionalism, confidentiality, and thoroughness.
• Ability to work in a diverse and multi-cultural environment with cultural sensitivity.
• Able to maintain confidentiality of sensitive information.
• Consistently exhibits professional demeanor and appearance.

Job Specific Duties

• Works with the Chief Research Officer and other stakeholders to support the research mission of NCHS.
• Serve as the Human Research Protections Program Administrator for the Health System.
• Assesses, develops, implements, and evaluates department goals that align with the Health System goals on a yearly basis.
• Identifies training requirements, establishes research training, and education curricula to meet regulatory requirements for investigators, research staff, and trainees.
• Fosters effective research and infrastructure collaborations that advance the NCHS missions in conjunction with key stakeholders.
• Develops and oversees the Research Institute budget.
• Ensures NCHS research and scientific programs comply with all relevant laws and regulations and works with Legal and Compliance & Ethics to have an appropriate quality improvement and oversight plan in place.
• Represents NCHS on a regional and national level and has regular interactions with colleagues from leadership, administrators, and clinicians regarding current and future research initiatives.
• Supports and coordinates outreach for research opportunities and institutional research affiliations.
• Responsible for the administration and management of the RI units and staffs (e.g. Clinical Research Operations and Regulatory Affairs).
• Establishes governance and infrastructure to support research activities across NCHS and with external partners.
• Provides oversight and administrative support for research compliance committees (e.g., Institutional Review Board, Institutional Animal Care and Use Committee, etc.).
• Facilitates the expansion of extramural funding and business development with industry partners.
• Works closely with the Foundation to develop and steward gifts, grants, and other external funding sources.
• Oversees or directly supervises staff, including hiring, orientation, training, evaluation, and termination within established guidelines.