Program Lead International Fontan Registry

Location
Washington, District of Columbia-Washington
Posted
Aug 19, 2020
Closes
Sep 18, 2020
Ref
200001FK
Function
Nurse
Industry
Healthcare
Hours
Full Time
The Children's National Hospital (CNH) Department of Cardiac Surgery is one of the prominent programs looking to further expand its reach nationally and internationally. It has a strong commitment to direct future changes in healthcare and lead innovation solutions. The Heart Research Program at CNH comprises exceptional researchers and clinicians who have led major advances in the care of children with congenital heart disease particularly in the field of arrhythmias, fetal medicine and neurodevelopmental outcomes. It aims to provide holistic care in a lifetime perspective for children and families affected by congenital heart disease.

The International Fontan Registry will gather health data on entire populations affected by the most severe congenital heart disease: being born with a single pumping heart chamber. We have agreement to share a large dataset with our partner organizations in the US, Europe and Australia. It will be the largest database on this population and is expected to be a central point of contact and reference for researchers, with the goal of being the critical force driving change in this field with connections in Genetics, Allied Health, Neurology, Psychology and innovative therapies. The program is built on the success of the Australia and New Zealand Fontan Registry. The Program Lead will support the Principal Investigator and play a key role in coordinating this international effort as well as developing a robust highly productive academic research infrastructure.

Under the direction of the Principal Investigator the Clinical Research Program Lead overseas the operational aspects, logistics and program management of the International Fontan Registry for patients who have undergone a Fontan operation. The Fontan Registry is a longitudinal cohort registry that aims to study the long-term effects and health outcomes. The International Fontan Registry will initially build a common dataset aggregated from different centers that will be providing clinical data from patients collected and make it available to researchers. Participating sites are located in Australia and New Zealand, Toronto, the Mayo Clinic, Birmingham, Munich. Ann Harbor, Philadelphia and Texas. The registry is to be hosted in Washington, DC and all centres will contribute to the registry by providing clinical data annually. The Program Lead has direct contact managing patients in a clinical setting. This position will also be involved in coordinating a large cross-sectional study involving approximately 5 complex investigations in 3 locations and multiple study investigators.

The individual works independently and will under the direction of the PI lead the planning for the development of a robust research infrastructure and team to support the expansion of an international research program. The Program Lead collaborates with Clinical Research Coordinators and Assistants in addition to Statisticians and Data Managers to assure the timely completion of deliverables as appropriate. The position will develop policies and procedures to establish the Washington, DC Coordinating Center site. S/he supports department leadership, organizes and leads study meetings, liaises with collaborating departments and institutions, the Institutional Review Board (IRB), and is responsible for the creation and monitoring of study timelines and other project specifications. The position will interface with faculty, collaborators, and administration from different countries to report project progress and trouble shoot barriers.

Qualifications

Minimum Education
Bachelor's Degree in Science, technical or health-related field (Required).
Master's Degree (preferred).

Minimum Work Experience
BS/BA with 5 year relevant experience.

MS degree with 3 years relevant experience.

Doctoral degree with 2 years of relevant experience, project management and registry administration experience desire.

Required Skills/Knowledge
1. Ability to establish constructive working relationships with colleagues both locally and internationally.
2. Experience in and understanding of quantitative research methodologies.
3. Experience in directing and managing a team.
4. Experience in data and database management, data collection and analysis.
5. Multicenter research experience desired.
6. Excellent communication and interpersonal skills with the ability to collaborate with a diverse group of VA and university researchers and staff.
7. Experience with customer service, particularly by telephone.
8. Strong attention to detail and organizational skills.
9. Solid problem-solving and critical thinking skills.
10. Excellent time management skills.
11. Ability to adapt to changing priorities and timelines.
12. Proficiency in Microsoft Office programs (e.g. Word, Excel, PowerPoint, and Outlook) required; experience with Microsoft Access, REDCap, and SharePoint strongly preferred.

Functional Accountabilities

Responsible Conduct of Research
1. Consistently demonstrate adherence with the standards for the responsible conduct of research.
2. Maintain confidentiality of data as required.
3. Plan, conduct, and manage research and/or research intervention projects within the federal and institutional regulations and policies under the direction of the principal investigator.
4. Responsible for appropriate use of research funds and resources.
5. Ensure compliance with all annual job-related training requirements.

Research and Project Management
1. Effectively manage day-to-day project operations and activities and direct the research staff for multiple multicenter research projects.

2. Ensure that deadlines are met.

3. Assist in the production of reports and publications.
4. Assists upper management in the development, implementation and evaluation of services, programs, policies and procedures, and performance standards to achieve research team goals.
5. Oversight of the research budget and cost center.
6. Liaising with Clinicians (Doctors, Nurses and Allied Health Professionals) in relation to the study.
7. Design, establish, and maintain an organizational structure and staffing to effectively accomplish the organization's goals and objectives; oversees recruitment, training, supervision, and evaluation of staff as assigned.
8. Manage the storage of data for previous studies and continue to manage the data storage for current studies.
9. Take the lead in writing IRB applications.
10. Assist in/contribute to research and publications including brochures, abstracts, posters and presentations.
11. Ensuring the studies are conducted according to ICH-GCP.
12. Write and assist with NHMRC and other grants, and assist with seeking and obtaining sources of funding for the ongoing trials and research personnel.
13. Write and monitor ethics applications, if necessary, under the guidance of the head of the research group.
14. Is aware of and adheres to CNH policy on Intellectual Property / Material

Transfer Agreements / Contracts / Clinical and Public Health Outcomes.
15. Assist with linking key stakeholders and other relevant organizations.

Decision Making Accountability
1. Coordination and day to day management of the Research Projects led by the PI, problem solving issues and ensuring the principle investigators are up to date with all matters.
2. Ensure familiarity with the several trials under the guidance of the PI and other investigators.
3. Supervise and support the set-up and continual running of trials at all sites.
4. Coordination of teleconferences, preparation of reports for regular study meetings, stakeholder meetings and seek interested and relevant organizations to assist with the transfer of knowledge.
5. Develop resource material for clinical and research staff.
6. Ensuring effective dissemination and transfer of knowledge and results through publications and presentations.
7. Oversee the roles and functions of other research staff employed for specific studies.
8. Coordinates and ensures the effective transfer of research outcomes into health policy and practice.
9. Assist with the development of national clinical guidelines from the results of the research studies and dissemination of the guidelines and results.

Leadership and Management
1. Is involved in professional development opportunities.
2. Share information and present to others within the Research Group or Theme and seek opportunities to contribute to the skill development of others.
3. May direct the work of students and interns.
4. Establish work plan and staffing for each project phase and arrange for recruitment or assignment of project personnel.
5. Assist in knowledge sharing, development and support of new team members.
6. Advertise positions, interview staff and complete the employment process for new team members.
7. Organizing and coordinating study days for members of the multicenter research team.
8. Support for and involvement in publication of research results.

Finance and Program Administration
1. Comply with CNH financial management policies and procedures.
2. Plan, direct and coordinate activities of designated project(s) to ensure that goals or objectives of the project are accomplished within prescribed time frame and funding parameters. Alter plans and make recommendations for future project phases or future projects, based on lessons learned from the project.
3. Comply with funding bodies policies and procedures.

4. Provide technical advice and support within area of expertise to colleagues.
5. Be proactive in the design and implementation of efficiency systems.
6. Ensure effective day to day management of areas of responsibility.
7. Develop processes for the efficient use of funds for the study.
8. Coordination of the Fontan Registry and dissemination of information.

9. Involvement, in the promotion of research links with outside bodies.
10. Contribute to the strategic direction of the research group and research network.
11. Is Involved where appropriate, in the promotion of research links with outside bodies.
12. Seeks to facilitate or develop interactions within the Research Group, Theme and across relevant disciplines through collaboration.

Organizational Accountabilities
Organizational Commitment/Identification

1. Anticipate and responds to customer needs; follows up until needs are met.

Teamwork/Communication

1. Demonstrate collaborative and respectful behavior.
2. Partner with all team members to achieve goals.
3. Receptive to others' ideas and opinions.

Performance Improvement/Problem-solving

1. Contribute to a positive work environment.
2. Demonstrate flexibility and willingness to change.
3. Identify opportunities to improve clinical and administrative processes.
4. Make appropriate decisions, using sound judgment.

Cost Management/Financial Responsibility

1. Use resources efficiently.
2. Search for less costly ways of doing things.

Safety

1. Speak up when team members appear to exhibit unsafe behavior or performance.
2. Continuously validate and verify information needed for decision making or documentation.
3. Stop in the face of uncertainty and takes time to resolve the situation.
4. Demonstrate accurate, clear and timely verbal and written communication.
5. Actively promote safety for patients, families, visitors and co-workers.
6. Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance.

Children's National Health System is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law.

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