Clinical Research Specialist

Allina Health System•Saint Paul, MN

5h•$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. 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. Key Position Details: 1.0 FTE (80 hours per two-week pay period) 8-hour day shifts No weekends Occasional floating to other metro sites as needed

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)

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
Collaborative Institutional Training Initiative (CITI Program) Certification to be completed within (180 days) of hire (offered through Allina Health)

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.