Clinical Research Specialist

Allina Health • Minneapolis, MN

5d • $29 - $40

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: 1.0 FTE (80 hours per two-week pay period) 8-hour day shift No weekends Will work at Abbott Northwestern Piper Building & West Health Plymouth Oncology experience preferred Job Description: Provides multifaceted support to the clinical research department in clinical research department in the clinical trials study activities. Provides 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.

Requirements

• Associate's or Vocational degree in a medical or science field
• 0 to 2 years of experience in clinical research
• Must meet at least ONE of the requirements below ◦ Current BLS certification from the American Heart Association ◦ Current BLS certification from the American Red Cross ◦ Allina in-house BLS training (within 30 days of hire)
• Collaborative Institutional Training Initiative (CITI Program) Certification to be completed within (180 days) of hire (offered through Allina Health)

Nice To Haves

• Bachelor's degree in a medical or science field
• Certified Clinical Research Coordinator preferred upon hire
• Certified Clinical Research Professional preferred upon hire
• Oncology experience preferred

Responsibilities

• Studies Feasibility Activities - in conjunction with research manager and team. Evaluates overall feasibility of the study at the clinical research center and identify budget items needed to perform the study. Evaluates new study protocols: Assesses protocol criteria to determine target enrollment goals related to patient population. Determines and orders special equipment and laboratory needs for new studies. Completes Radiology and Imaging Capabilities Assessment Forms.
• Studies Start-Up Activities - with research team. Prepares and participates in site qualification visits and site initiation meetings. Collaborates on developing study plan of execution. Assists with recruitment strategies to enhance study enrollment. Creates study-specific tools and materials for protocol implementation. Collaborates with team members in preparing regulatory documents, study materials, laboratory kit supplies, informed consent forms, and recruitment materials. Educates internal and external personnel about studies; provide guidance in implementing study protocols.
• Studies Management Activities. Screens medical records for potential study participation based on protocol inclusion and exclusion criteria. Conducts and documents the informed consent process with potential research subjects in accordance with SOPs and Institutional Review Board (IRB) requirements. Develops, implements, and evaluates plan of care based upon individual patient and family assessment. Utilizes appropriate procedures, interpreters, forms, etc. for patients with special communication needs. Evaluates study participants and complete all study-related activities including diagnostics, and laboratory procedures. Performs study-related activities and assessments within the scope of training and certification. Manages source documentation and accurately report data in case report forms for each study subject during the study. Ensures all data is entered within sponsor-specified parameters. Resolve queries within the sponsor-specified time periods. Serves as liaison with principal investigator, research staff, clinical care team, and sponsor regarding patient care issues and progress on the study. Communicates about study with the study staff and sponsor regarding patient care issues and study progress. Prepares for study monitoring and audit visits. Oversees study close-out visits.
• Assists and Collaborates. Assists with lab kit receipt, storage and preparation, ECG monitoring, sending imaging for central review, and preparing and sending lab specimens to central laboratories. Collaborates with members of the research team to ensure the proper collection, processing and shipment of pathology and laboratory specimens. Communicates effectively with member of the research and clinical care teams in person and at meetings. 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