Job Summary

Job Duties

• Works with principal investigator and research team to implement funded studies.
• Develops and manages study budgets, including complex and multi-site study budgets.
• Participates in long-range financial forecast of expenditures, anticipates variances and independently implements corrective measures within study budgets and protocol parameters.
• Contributes to determining research departmental needs and financial resources and preparing annual departmental and study budgets, as applicable.
• Responsible for all regulatory documents and reporting requirements of studies.
• Leads self-audits of studies to ensure regulatory compliance and reports findings to the IRB and Office of Research Compliance.
• Oversees development, implementation and management of protocols for research and quality projects.
• Responsible for leading implementation of a project plan and for overall project management including directing and mentoring research staff, management of the study team, progress tracking and reporting, quality control, recruitment and enrollment, and and research support staff training.
• Serves as lead manager of all research project-related activities to meet project goals and milestones, based on study design.
• Communicates resource needs, issues, project status and milestones met to project team, research investigators and key stakeholders.
• Coordinates and delegates the development and delivering of study specific material to project staff.
• Anticipates problems and implements preventative action.
• Handles sensitive project and personnel issues and provides resolution.
• Hires, trains and supervises project staff.
• Serves as a leader within the department by participating in research committees, contributing to decision-making and strategic planning, and optimizing the organizational infrastructure to support research activities.
• Provides leadership in managing and coordinating activities with collaborating institutions, industry sponsors, grant funders, and investigators.
• Coordinates creation of data dictionaries, data management, data security and implementation of quality control procedures with data team.
• Trains and mentors junior level staff on medical codes and data management.
• Independently prepares sections of proposal narrative for funded studies and participates in development of the scope of work.
• Independently analyzes data, writes technical reports and final reports for sponsors.
• Provides substantial contribution to study manuscripts for publication, grant applications, and contract/budget negotiations and finalization.
• Trains junior staff on grant and contract submission, negotiation, and providing pre-award and post-award project management.

Work is typically performed in an office environment. Accountable for satisfying all job specific obligations and complying with all organization policies and procedures. The specific statements in this profile are not intended to be all-inclusive. They represent typical elements considered necessary to successfully perform the job.

Position Details

Education

Experience

Certification(s) and License(s)