Job Summary
Responsible for research study and project management to support internal trial and grant management. Responsible for leading cross-functional teams, driving forward all strategic trial-related initiatives, identifying and mitigating risks, and communicating with key partners and stakeholders. Defines work assignments and performance expectations for team members and identifies training and development for staff. Great team player, leader, and creative thinker.
Job Specific Duties

• Responsible for the lifecycle of NCHS authored research, including initial consultation with investigators regarding their research projects.
• Primarily responsible for assisting researchers with developing, writing and editing non-scientific portions of clinical research protocols and clinical trial protocols.
• Serves as the central resource within the Research Development Center to provide authoritative expertise and regulatory guidance on complex issues including but not limited to protocol development, and multi-site activation and study maintenance.
• Provides support in the preparation of foundation, state, and federal grant applications.
• Works collaboratively with study team members, regulatory and operational staff to develop or coordinate the development of the study design and protocol required information.
• Research and identify potential funding sources for new and ongoing research programs and initiatives in collaboration with the Office of Sponsored Programs.
• Advises and assists the Investigator, key study personnel, and other team members in the development of data tools, record keeping, study budget, process improvement plans, and efficient timelines for research studies; coordinates the ongoing analysis and modification of protocols; and recommends amendments to study protocols as appropriate.
• Confers with Investigators and key study personnel in the development of protocols and study budgets to capture all study costs and compliance with regulations; and assures adherence to FDA and other regulatory guidelines.
• In partnership with and at the behest of the principal investigator, may communicate with pharmaceutical or academic partners to obtain and facilitate operational protocols.
• Contributes to the development of the Research Institute team, logistics, operations, and training.
• Participates in meetings with research teams related to the identification and preparation of grant applications for investigators.
• Drafting collateral materials for grant applications including supplemental materials as needed.
• Ensures that the work products conform to the formatting and internal /external / policy / regulatory requirements, are free of errors, and that those ideas are presented, accurately, and persuasively.
• In collaboration with the Quality Coordinator and Research Development Manager, responsible for developing, implementing, and maintaining a comprehensive/strategic Continuous Quality Improvement (CQI) program for all NCHS authored projects.
• Maintain a master calendar of grant submission deadlines, a library of grant proposal support documents, and grant templates.
• Assist research teams with the drafting of internal press releases in collaboration with the Research Institute and NCHS Offices related to new grants/projects.
• Manages established timeline benchmarks, monitor progress, and informs key stakeholders of progress.
• Collaborate across NCHS departments to expedite and/or navigate resolving complex problems or issues causing barriers to research projects.
• Work closely with clients and stakeholders within the organization teams to lead the development of strategies for research projects.
• Perform day-to-day responsibilities, including management of project team with minimal supervision.
• Monitors and analyzes new legislation, federal regulations, guidance documents, and program initiatives. Keep abreast of current trends and changes in the research community to serve as subject matter expert for researchers to support, collaborate, and train to the specifics of NCHS SOPs and regulations.
• Maintain collaborative, proactive, and effective communication with both internal and external teams.
• Lead project-related meetings and teleconferences.
• Provide coaching to junior staff for study-level documents as well as submission-level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements.
• Develop concepts, progress reports, and solutions by coordinating with the Clinical and Operational team, and stakeholders (internal and external).
• Establish project goals and priorities by collaborating with the Clinical and Operations team.
• Research, design, and evaluate materials, processes, and deliverables.
• Develop concepts and solutions by working with the organization's business units.
• Monitor team metrics and objectives ensuring meeting of goals.
• Document all phases of research and development.
• Promotes training, accountability, and structure for the Research Development Center.
• Build relationships with the community, stakeholders, NCHS teams, Industry/ Federal sponsors, and the NCHS Foundation team.
• Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.

Minimum Job Requirements

• Master, PhD, or Research work experience
• Research writing experience or understanding of protocol overviews
• Leadership experience managing a multi-disciplinary project team that collaborate openly and effectively with a range of stakeholders, including research physicians

Knowledge, Skills, and Abilities

• Successfully negotiates project schedules, plans, and milestones with the team.
• Maintains design documentation to support quality and regulatory process requirements.
• Exceptional writing and communications skills.
• Ability to collaborate with internal member of the team and across the system.
• Demonstrated ability to problem solve, applies logic, and makes assessments based on data.
• Strong analytical skills.
• Ability to influence and gain consensus of project teams.