Allina Health · 1 week ago
Research Project Specialist - Care Delivery
Allina Health is a not-for-profit health system that cares for individuals, families, and communities throughout Minnesota and western Wisconsin. The Research Project Specialist will provide leadership in clinical research for clinical trials, managing patient enrollment, data management, and regulatory compliance. This role involves collaborating with research teams and overseeing various study-related activities to ensure adherence to research standards and guidelines.
Health CareHospital
Responsibilities
Screens electronic medical records to identify potential study participants based on protocol inclusion and exclusion criteria
Independently conducts and documents the informed consent process with potential research subjects in accordance with research standards of practice (SOP) and Institutional Review Board requirements
Develops, implements, and evaluates the patient’s plan of care based upon patient and family assessments
Completes all study-related activities including diagnostics, quality of life assessments, and laboratory procedures. Performs study activities and assessments within the scope of training and certification
Independently manage source documentation and accurately record data in case report forms for each study participant during the study
Communicates with principal investigator, research staff, clinical care teams, and sponsor regarding patient care issues and study progress
Prepares for study monitoring and audit visits and meet with monitor/auditor to resolve any discrepancies
Oversees study close-out and archiving of study data in accordance with research SOPs
Collects essential regulatory documents and facilitate Institutional Review Board submissions
Reviews and revises Informed Consent forms to match study protocol, regulatory requirements, and local Institutional Review Board policies
Creates study-specific tools and develop study plan of execution
Prepares regulatory documents, study materials, recruitment materials, laboratory kits
Ensures all documents are in compliance with the U/S Food and Drug Administration regulations
Educates internal and external personnel about studies; provide guidance to clinical staff regarding implementation of study protocol
Evaluates new study protocols to determine feasibility at the site, target enrollment goals related to available study population, and potential budget items to perform the study
Anticipates and orders special equipment and laboratory supplies for new studies
Provides Radiology and Imaging Capabilities Assessment Forms and phantom images required during study feasibility
Performs trial related invoicing and reimbursements with system and study sponsors
Maintains study database and perform data extraction from electronic medical records and or/patient charts
Conducts ongoing data analysis to generate interim study reports
Other duties as assigned
Qualification
Required
Associate's or Vocational degree in medical field
2+ years experience in research
Collaborative Institutional Training Initiative (CITI Program) Certification to be completed within 90 days of hire (offered through Allina Health)
Preferred
Bachelor's degree in biological sciences or related field
Certified Clinical Research Coordinator preferred
Certified Clinical Research Professional preferred
Benefits
Medical/Dental
PTO/Time Away
Retirement Savings Plans
Life Insurance
Short-term/Long-term Disability
Voluntary Benefits (vision, legal, critical illness)
Tuition Reimbursement or Continuing Medical Education as applicable
Student Loan Support Benefits to navigate the Federal Public Service Loan Forgiveness Program
Allina Health is a 501(c)(3) eligible employer
Benefit eligibility/offerings are determined by FTE and if you are represented by a union.
Company
Allina Health
Allina Health is a non-profit healthcare system that is is dedicated to the prevention and treatment of illness.
H1B Sponsorship
Allina Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (14)
2023 (12)
2022 (10)
2021 (3)
2020 (6)
Funding
Current Stage
Late StageRecent News
2026-01-12
2025-12-09
2025-11-11
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