Research Coordinator

HHRI; Minneapolis (MN); On-site; USD 55,000 - 75,000; Full time

Job summary

Hennepin Healthcare Research Institute's Restorative Neurotrauma Lab seeks an experienced Research Coordinator to support studies in the Division of Neurosurgery at HCMC. This role requires a consistent onsite presence in downtown Minneapolis, MN.

Responsibilities include study management, participant recruitment, regulatory submissions (IRB/FDA IDE/IND), grant support, data coordination, and collaboration with HHRI and external partners to advance current and new research projects.

Qualifications

• Experience with electronic medical records (EPIC) and regulatory documentation.
• Ability to write and prepare grant proposals and manage budgets.
• Experience recruiting patients and collecting research data.

Responsibilities

• Manage participant screening, recruitment, and engagement in research projects.
• Coordinate regulatory submissions (IRB, FDA IDE/IND) and study materials.
• Plan grants, abstracts, and publications; coordinate data collection across sites.
• Train new researchers and supervise project tasks.
• Monitor data integrity and coordinate budgets and expenditures.

Skills

MS Office

Data management

Regulatory knowledge

Communication

Education

Bachelor's degree

Tools

EPIC

Job description

The Hennepin Healthcare Research Institute's (HHRI) Restorative Neurotrauma Lab has a current opening for an experienced Research Coordinator to support the research being conducted by Drs. David Darrow and Sam Cramer in the Division of Neurosurgery at HCMC.

This role requires a consistent onsite presence in downtown Minneapolis, MN.

POSITION SUMMARY:

The Research Coordinator will assist with study management, coordination, teaching, overseeing research, and patient recruitment. Systemically coordinate and organize protocols while maintaining communication with Institutional review Board as well as the FDA regarding IDE/IND process. Routinely coordinate daily activities associated with administering sponsored and non-sponsored research projects. Aid in grant application and accurately reconcile grant accounts. Manage hardware and software needed for research projects. Assist with submission of grant proposals, abstracts, and publications. Work with collaborators (across external academic institutions) and research staff (within HCMC/HHRI) to coordinate ongoing research projects and develop new projects.

ESSENTIAL JOB FUNCTIONS:

• Responsible for managing tasks associated with participant screening, recruitment, and engagement in research projects, which includes, but is not limited to:
  • Determining participant eligibility
  • Recruitment
  • Tracking enrollment dates and key patient milestones
  • Coordinates/conducts research participant testing and follow-up.
  • Completing and securely storing paperwork
  • Collects data in an organized and precise fashion and maintains data integrity
  • Coordinates multiple data collection efforts for one or more research projects which may include other collaborating agencies or institutions.
  • Orient, train or teach, and give work direction to new researchers on the project
• Coordinate studies across collaborators
• Act as a resource to other staff regarding study protocol and interpretations
• Responsible for regulatory compliance in conjunction with the PI by providing study materials requested including, but are not limited to:
  • Develop and maintain project materials (e.g., patient database, case report forms, study worksheets, tracking logs, IRB required forms, etc.)
  • Accurately write and revise clinical protocols, consents, and other supporting documents
  • Assist the Principal Investigator with reaching project milestones and resource allocation to assure successful study conduct
  • Oversee progress and assure milestones are met for the research activities conducted by collaborators at external academic institutions
  • Organize, and coordinate meetings, conference calls, and training sessions
  • Management of patient advisory group
  • Consult with the Principal Investigator and co-investigators on appropriate management of participant problems and concerns.
  • Write and edit technical reports and manuscripts for publication or presentation.
  • IRB (submissions and renewals)
  • FDA IDE/IND processes
  • Create reports as mandated by sponsor/funder and manage digital log viewable by PI

• Monitor fiscal and administrative activities satisfying guidelines established by both the institution and various funding agencies.
  • Preparation of budgets
  • Review/approve expenditures
  • Invoice submission
  • Budget/expenditure reconciliation
  • Supply orders
  • W-9 monitoring for study subjects
  • Liaison between the project team and funding agencies or significant parties.
  • Accurately reconcile grant accounts
• Guide proposals through inception to submission stages. Plan future proposal submissions
  • Assist with submission of new grant proposals by completing funding agency forms
  • Collaborate with HHRI grant administration.
  • Works with other members of the research team on research design and problem solving.
• Aid in the planning and writing of grants, abstracts, and publications.

EMPLOYMENT STANDARDS:

Education/Experience:

Any equivalent combination of education and experience that provides the required knowledge and skills is qualifying. Typical qualifications would be a baccalaureate degree and one to three (1-3) years of experience with the specified research field. Experience with electronic medical records (EPIC), regulatory documentation, writing and preparing grant proposals and managing research budgets, preferred. Experience implementing clinical research protocols, recruiting patients for research studies, data gathering, and maintaining research data.

Skill, Knowledge & Ability (SKA):

Requires interaction with a diverse population. Must demonstrate working knowledge of MS Office including: databases, spreadsheets (including pivot tables, basic statistical analysis, etc.), and word processing. Knowledge of research design, protocols, and analysis; knowledge of regulatory aspects of clinical research. Ability to work independently within guidelines, be organized, prioritize work effort in relation to project requirements. Skilled in problem solving and keeping detailed records and files. Effective written and oral communication skills. Displays high standards of attendance, punctuality, maintains confidentiality, and manages time effectively. Required skills includes: Self-motivated and ability to work independently.

Equal Opportunity Employer