Research Project Specialist - Care Delivery

Allina Health

4d • $33 - $46

About The Position

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: This position primarily supports a range of investigator-led research studies (rather than clinical trials) within the care delivery research portfolio and Allina’s Mother Baby areas as needed. Collaborating with Allina Health Research scientists and providers from CDR and other research teams, the candidate will perform various duties related to study planning, participant enrollment, data management, regulatory (IRB) maintenance, and dissemination of findings. Full time position (80 hours in a two week pay period) 8 hour Day shifts No Weekends Job Description: Provides leadership in the clinical research department for clinical trials study activities including patient enrollment and assessments, data management, study material preparation, regulatory document preparation, and project coordination 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.

Requirements

• Associate's or Vocational degree in medical field
• 2+ years experience in research

Nice To Haves

• Bachelor's degree in biological sciences or related field
• Collaborative Institutional Training Initiative (CITI Program) Certification to be completed within 90 days of hire (offered through Allina Health)
• Certified Clinical Research Coordinator preferred
• Certified Clinical Research Professional preferred

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.
• Collects essential regulatory documents.
• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree