Clinical Research Specialist

Allina Health•Minneapolis, MN

22h•Onsite

About The Position

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
Current BLS certification from the American Heart Association or American Red Cross or 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

Responsibilities

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