Clinical Research Navigator — Senior/Intermediate

University Of Michigan

Ann Arbor (MI)

Hybrid

USD 85,000 - 120,000

Full time

3 days ago
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Benefits offered by this job

Excellent medical, dental and vision 1
2:1 retirement match
Hybrid or mobile/remote work mode

Job summary

Michigan Medicine, Department of Cardiac Surgery, seeks a Research Area Specialist to support the full lifecycle of clinical and outcomes research studies. You will guide study design, regulatory affairs, data governance, and daily operations while collaborating with investigators, staff, and partners.

The role focuses on process improvement, quality assurance, and ensuring adherence to federal and institutional requirements across study lifecycles.

Qualifications

  • Bachelor's degree in health sciences, biological sciences, public health, research administration, or another related field.
  • Senior Level: 5-8 years of progressively responsible experience supporting research.
  • Intermediate Level: 3-5 years of progressively responsible experience supporting research.
  • Experience interpreting and applying federal regulations, sponsor requirements, and institutional policies to complex research activities.
  • Experience with research management systems such as REDCap, EMERSE, eResearch, and other related applications.
  • Experience preparing grant proposals, research budgets, and sponsor submissions.
  • Strong understanding of research data management, documentation standards, and quality assurance practices.
  • Excellent written and verbal communication skills with the ability to effectively consult with faculty, researchers, and institutional partners.

Responsibilities

  • Serve as the department's primary resource for planning, development, and administration of clinical and outcomes research studies.
  • Consult with faculty investigators regarding study design, methodology, feasibility, and implementation strategies.
  • Provide guidance throughout the study lifecycle, including startup, conduct, amendments, continuing review, and closure.
  • Assist investigators with protocol development and research documentation.
  • Support proposal development, budgeting, and administrative requirements for sponsored research.
  • Identify operational challenges and develop practical solutions to improve efficiency, quality, and compliance.
  • Coordinate regulatory activities for research studies, including IRB submissions and continuing reviews.
  • Monitor regulatory timelines and maintain current knowledge of evolving federal regulations and policies.
  • Administer access to research applications and institutional systems (REDCap, MiChart, etc.).
  • Maintain study records, regulatory documentation, sample inventories, and tracking databases.
  • Coordinate communications with clinical research units and institutional partners.
  • Represent the department on committees related to research administration and compliance.
  • Mentor research personnel and provide ongoing consultation to promote best practices.

Skills

Communication skills
Regulatory knowledge
Research management
Data governance
Analytical skills

Education

Bachelor's degree in health sciences

Tools

REDCap
EMERSE
eResearch
MiChart

Job description

Michigan Medicine, Department of Cardiac Surgery, seeks a Research Area Specialist to support the full lifecycle of clinical and outcomes research studies. You will guide study design, regulatory affairs, data governance, and daily operations while collaborating with investigators, staff, and partners.

The role focuses on process improvement, quality assurance, and ensuring adherence to federal and institutional requirements across study lifecycles.

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