Executive Director, Clinical Research

The Executive Director will lead, and facilitate the effective management of the day-to-day clinical research clinical and administrative operations that support the integrated funded research enterprise of Children's National Health System. This position will report to the Vice President, Academic and Research Operations in collaboration with the Institutional Official for Children's National Research Institute and is responsible for the development and oversight of an integrated high quality clinical research infrastructure of Children's National Research Institute. The individual exercises leadership and management responsibility over all management functions within this portfolio to ensure efficient services are designed to meet the needs of the CNRI research faculty and staff. The position is responsible for the development and the operations of centralized Clinical Research Support Office (CRSO). The CRSO will provide a centralized home for clinical research support staff including clinical research assistants, coordinators and nurses and will provide consistent oversight and management, ongoing education and training. The CRSO will be responsible for the pre-award support for clinical research including coverage analysis and budget preparation and will closely collaborate with clinical departments such as Lab, Radiology, Cardiology and administrative support such as the Grants and Contracts Proposal Development Team. The Executive Director will be responsible for the oversight, management and operations of the Clinical Research Unit ensuring efficient operations and support and services for clinical research studies that utilize their services

Qualifications

Minimum Education
Bachelor's Degree Bachelor's degree in scientific, medical or regulatory discipline. (Required)
Master's Degree Clinical Research Administration, Hospital Administration, Business Administration, or related field (Preferred)
Minimum Work Experience
10 years Progressively responsible experience in research/clinical research administration within a major academic medical center or university with proven success in business and program development, implementation and facilitation of strategic processes, and fiscal responsibility. (Required)
7 years Supervisory/management experience in related job functions, Experience with managing/conducting NIH-funded clinical research, industry sponsored clinical trials, and investigator-initiated clinical protocols as required. (Required)

7 years Pediatric clinical experience (Preferred)

Required Skills/Knowledge

• Strong project management, facilitative leadership, detail orientation, organizational, customer service, and oral written communication skills

• Strong knowledge of clinical process, medical terminology, and the clinical research lifecycle required

• Proficient working knowledge of Microsoft Office Suite including Excel and multiple IT systems

• Strong leadership and negotiation skills.

• High degree of professionalism and integrity.

• Strong knowledge of Code of Federal Regulations (CFRs), including NIH, FDA and OMB Circulars (A-21, A-110, A-133) in addition to federal grant budgeting and submission guidelines and other regulatory agency requirements.

• Project, program and portfolio management competencies.

• Excellent interpersonal and communication skills.

• Ability prioritize work in a fast-paced, complex environment with multiple, conflicting interests.

• Ability to work across teams and with a variety of projects and constituencies.

• Ability to lead, motivate and provide guidance and coaching to members of the team.

Functional Accountabilities

Responsible Conduct of Research
• Consistently demonstrates adherence to the standards for the responsible conduct of research.
• Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction
of the principal investigator.
• Uses research funds and resources appropriately.
• Maintains confidentiality of data as required.
• Meets all annual job-related training and compliance requirements.

Execution of Vision and Strategy into Optimal Organization Performance
• Optimizes the research infrastructure that supports clinical and translational research at Children’s National aligning with
needs of academic and industry sponsors
• Participate in the execution of the CNRI strategic plan, establish short and long range operational goals, and objectives
that will enhance and support clinical research efforts
• Monitor departmental processes and seek opportunities to improve operations
• Develops programs to enhance the operations of the department and to increase the ability of researchers to conduct
research in a compliant and ethical manner
• Plans, implements, directs and evaluates administrative units on a strategic and operational level to ensure the CNH
receives continued funding through various sponsors including federal, state, local and industry sponsors
• Ensures ongoing local programmatic excellence, rigorous program evaluation and consistent quality of finance and
administration, communications and systems.
• Ensures effective systems to track productivity and impact and regularly evaluates program components, so as to measure
successes that can be effectively communicated internal and external constituents
• Participates in institutional committees as appropriate
• Demonstrates ethical and professional practices.

Program and Service Administration and Implementation
• Designs, establishes and maintains the Clinical Research Support Office (CRSO) organizational structure and staffing to
effectively accomplish CNRI’s goals and objectives. The CRSO will include the centralization of the management for
research support staff including clinical research assistants, coordinators and nurses
• Leads intra- and inter-institutional coordination and assurance of operational compliance with institutional, federal and
grant guidelines/regulations in regard to grant management and human subject protection.
• Develops and manages clinical research related policies, procedures, templates and other shared documentation that are
consistent with institutional, federal, state and local regulations, Good Clinical Practice (GCP) guidelines, other human
subjects research requirements and guidance.
• Provides oversight and authoritative guidance for staff supporting pre-award activities including Coverage Analysis and
Study Budget Development to ensure billing compliance, clinical trials coverage determinations that are consistent with
federal policies and guidelines and budgets that ensure fiscal responsibility.
• Provide oversight of clinical research information systems including OnCore Clinical Research Management Systems
• Develops and delivers an educational curriculum for clinical research staff including consistent onboarding and orientation,
routine continuing education and competency-based training that is grounded in best practices.
• Provides oversight and management of the Clinical Research Unit
• Recommends timelines and resources needed to achieve the strategic goals
• Coordinates communication across CNRI and CNH

Management of Personnel and Partnerships
• Design, establish and maintain an organizational structure and staffing to effectively accomplish organizational goals and
objectives; oversees recruitment, training, supervision, and evaluation of staff. Develops job descriptions that are
consistent with industry best practices
• Leads management functions within the portfolio of the CRSO to ensure efficient resources and services are designed to
meet the needs of research faculty and staff.
• Serves as a member of the CNRI administrative team, making decisions that impact the entire CNRI research and business
portfolio.
• Sees oneself as a leader of others, from forming a top team that possesses balanced capabilities to setting the mission,
values and norms.
• Holds team members accountable for results individually and collectively.
• Establishes, builds and sustains professional contacts for the purpose of building networks of people with similar goals that
support similar interests.
• Oversees the CRSO HR initiatives and provide strategic guidance to faculty, research staff and administrators on Human
Resource issues.
• Leads, coaches, develops, engages and retains CRSO high-performance management team and staff.
• Deepens and refines all aspects of communications, from web presence to external relations, with the goal of creating a
stronger infrastructure.
• Builds and maintains trust with partners and external authorities.

Budget and Finance Management
• Partner in planning, development and management of the CRSO operating and capital budget
• Independently develop and monitor operations and project budgets
• Ensures study team’s compliance with clinical research billing policies and procedures.
• Monitor performance reports and evaluate budget variances
• Consistently utilizes cost effective resources and meets budget and staffing requirements.
• Incorporates budget considerations into all planning and decision-making.

Leader Accountabilities Director/Executive Director/Associate Division Chief/Division Chief

Deliver
• Set and achieve departmental goals.
• Align budgets and resources to meet division goals.
• Monitor and support a safe and quality environment.
• Focus the team on service excellence and make the interdepartmental connections needed to ensure high service.

Engage
• Clearly communicate organizational strategies to the department.
• Ensure managers hold the team accountable for high performance.
• Support managers in maintaining a positive working environment.
• Represent the department in clearing obstacles to high performance.
• Look for and develop high-performing talent.
• Support supervisors and managers in engagement efforts.

Grow
• Look across departments for opportunities to make the organization more effective.
• Recognize and share innovation and improvement.
• Represent the department in organization-wide innovation and improvement efforts.
• Monitor and grow the department’s capacity for change

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