Description

Job Summary

Responsible for developing and implementing in collaboration with the VP for Research, strategy to drive the sustainable growth of the Research Enterprise for the Health System. Build and grow the Office of Research including teams, responsible for Research Administration including grant and contract administration, collaboration with external sponsors and external researcher partners, financial management, and financial monitoring and auditing Research Operations. Manages clinical services and team of research coordinators, Research Compliance including regulatory affairs, making human subject exempt determinations, serving as interface with external IRBs, coordinating the conflict of interest/commitment review process, and research monitoring and auditing.  

Job Specific Duties

• Collaborate and works with the senior leadership and stakeholders to develop and implement the strategy for the research mission of Nicklaus Children's Health System. 

• Grows the research portfolio in terms of subject enrollment, as well as, grant and philanthropic funding. 

• Works with the clinical institutes and departments on recruitment of faculty involved in clinical research. 

• Serves 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 Nicklaus Children's Health System missions in conjunction with key stakeholders. 

• Develops and oversees the Research Institute budget. 

• Ensures Nicklaus Children's Health System research and scientific programs comply with all relevant laws and regulations.  Works with Legal, Compliance, and Ethics to have an appropriate quality improvement and oversight plan in place. 

• Represents Nicklaus Children's Health System 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 Nicklaus Children's Health System and external partners. 

• Provides oversight and administrative support for research compliance committees (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

Qualifications

Minimum Job Requirements

• Master's Degree in Biomedical field

• Clinical Research Professional Certification (e.g. CCRC, CCRP, or CCRA)

• 7-10 years of experience in managing projects, leading teams, and stewarding financial resources and experience with operational budgets

• 5+ years of progressive management and leadership in biomedical research operations and administration

Knowledge, Skills, and Abilities

• Doctoral degree (MD, DO, or PhD) preferred.

• Clinical Research Professional such as CCRC, CCRP, or CCRA.

• 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.

• 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.

• Highly organized skilled administrator with the ability to manage and prioritize multiple projects and coordinate cross-discipline research projects and interdisciplinary programs.

• Ability to work as a member of a collaborative and interdisciplinary team to forward the objectives of the Research Institute.

• Expert knowledge of federal regulations governing research.

• Leadership qualities, involving managing diverse teams.

• Ability to set and effectively communicate priorities, 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 or clinical group/team.

• Ability to work as a member of a collaborative and interdisciplinary team to forward the objectives of the Research Institute.

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