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CHEManager International · 1 day ago

Clinical Research Specialist

Minneapolis, MN

Full-time

Onsite

New Grad, Entry Level

$28.67/hr - $39.29/hr

0+ years exp

Allina Health is a not-for-profit health system that cares for individuals, families and communities throughout Minnesota and western Wisconsin. The Clinical Research Specialist provides support to the clinical research department in clinical trials, including patient enrollment, data management, and regulatory compliance.

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Responsibilities

Evaluate overall feasibility of the study at the clinical research center and identify budget items needed to perform the study

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

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

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 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

Qualification

Clinical research experienceRegulatory document preparationPatient enrollmentBLS certificationCITI Program CertificationCommunication skillsCollaboration skills

Required

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

0 to 2 years of experience in clinical research

BLS Tier 1 - Basic Life Support - Multisource required within 60 Days

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