Clinical Research Specialist

Location Address:

4050 Coon Rapids Blvd NW Coon Rapids, MN 55433-2522

Date Posted:

August 14, 2025

Department:

16000480 AHCI Research

Shift:

Day (United States of America)

Shift Length:

8 hour shift

Hours Per Week:

40

Union Contract:

Non-Union-NCT

Weekend Rotation:

None

Job Summary:

Allina Health is a not-for-profit health system that cares for individuals, families and communities throughout Minnesota and western Wisconsin. If you value putting patients first, consider a career at Allina Health. Our mission is to provide exceptional care as we prevent illness, restore health and provide comfort to all who entrust us with their care. This includes you and your loved ones. We are committed to providing whole person care, investing in your well-being, and enriching your career.

Key Position Details:

• 1.0 FTE (80-hours per 2-week pay period)

• 8-hour day shifts

• May require occassional travel to one of the other facilities depending on business needs

• No weekends

Job Description:

Provides multifaceted support to the clinical research department in clinical research department in the clinical trials study activities. Provide patient enrollment and assessments, data management, and study material preparation. Prepares regulatory documents, and coordinates project in accordance with research standard operating procedures, federal and state regulations, Institutional Review Board (IRB) requirements, and International Council on Harmonization Good Clinical Practice guidelines.

Principle Responsibilities

• Study Feasibility Activities - in conjunction with research manager and team.
  • Evaluate overall feasibility of the study at the clinical research center and identify budget items needed to perform the study.
  • Evaluate new study protocols: Assess protocol criteria to determine target enrollment goals related to patient population.
  • Determine and order special equipment and laboratory needs for new studies.
  • Complete Radiology and Imaging Capabilities Assessment Forms.
• Study Start-Up Activities - with research team.
  • Prepare and participate in site qualification visits and site initiation meetings.
  • Collaborate on developing study plan of execution.
  • Assist with recruitment strategies to enhance study enrollment.
  • Create study-specific tools and materials for protocol implementation.
  • Collaborate with team members in preparing regulatory documents, study materials, laboratory kit supplies, informed consent forms, and recruitment materials.
  • Educate internal and external personnel about studies; provide guidance in implementing study protocols.
• Study Management Activities.
  • Screen medical records for potential study participation based on protocol inclusion and exclusion criteria.
  • Conduct and document the informed consent process with potential research subjects in accordance with SOPs and Institutional Review Board (IRB) requirements.
  • Develop, implement, and evaluate plan of care based upon individual patient and family assessment.
  • Utilize appropriate procedures, interpreters, forms, etc. for patients with special communication needs.
  • Evaluate study participants and complete all study-related activities including diagnostics, and laboratory procedures.
  • Perform study-related activities and assessments within the scope of training and certification.
  • Manage source documentation and accurately report data in case report forms for each study subject during the study.
  • Ensure all data is entered within sponsor-specified parameters. Resolve queries within the sponsor-specified time periods.
  • Serve as liaison with principal investigator, research staff, clinical care team, and sponsor regarding patient care issues and progress on the study.
  • Communicate about study with the study staff and sponsor regarding patient care issues and study progress.
  • Prepare for study monitoring and audit visits.
  • Oversee study close-out visits.
• Assist and Collaborate.
  • Assist with lab kit receipt, storage and preparation, ECG monitoring, sending imaging for central review, and preparing and sending lab specimens to central laboratories.
  • Collaborate with members of the research team to ensure the proper collection, processing and shipment of pathology and laboratory specimens.
  • Communicate effectively with member of the research and clinical care teams in person and at meetings.
• Other duties as assigned.

Required Qualifications

• Associate's or Vocational degree in a medical or science field
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