Fairview Health Services
Clinical Research Specialist
Fairview Health Services, Minneapolis, Minnesota, United States, 55400
Overview
The Clinical Research Specialist is responsible for providing critical logistical support for the successful operation of investigational medication clinical trials conducted throughout the M Health Fairview system. This position collaborates with a variety of M Health departments and study team members to drive high-quality participant medication safety, quality assurance, customer service, process improvement, investigational dispensing, and regulatory compliance. Responsibilities
Communicate with principal investigators, trial coordinators/research assistants, study monitors, and pharmacists to provide technical direction and assistance with clinical research protocol management. Create and maintain electronic trial builds containing study summary, protocol, dispensing procedures, dispensing checklist, fee/billing schedules and other materials specific to each clinical trial. Educate and train internal/external pharmacy staff on dispensing procedures related to specific protocols. Act as a general educational and technical resource to students, staff, and interdisciplinary members of the study team. Collaborate with clinical research staff to prepare internal dispensing guidelines for internal and external departmental use. Participate in investigational medication preparation/dispensing, completion of study documentation, and detailing of protocol related activities according to federal, state, and departmental regulations and standard operating procedures. Communicate with interdisciplinary study team members to ensure appropriateness of trial orders, investigational product management, adherence to protocols, and compliance with any other regulatory or departmental initiatives as appropriate. Perform accountability for the receipt, storage, distribution, and sterile/non-sterile preparation of investigational medications, supplies, and products as specified per study protocol. Maintain proficiency in the skills and theory of the practice of clinical research pharmacy by reviewing literature, attending in-services, seminars, conferences, and actively participating in department clinical research meetings and activities. Participate in regulatory, quality assurance and process improvement activities as the need arises. Organization Expectations
Demonstrates ability to provide care or service adjusting approaches to reflect developmental level and cultural differences of population served. Partners with patient care giver in care/decision making. Communicates in a respectful manner. Ensures a safe, secure environment. Individualizes plan of care to meet patient needs. Modifies clinical interventions based on population served. Provides patient education based on assessment of learning needs of patient/care giver. Fulfills all organizational requirements and completes all required learning relevant to the role. Complies with and maintains knowledge of all relevant laws, regulations, policies, procedures and standards. Fosters a culture of improvement, efficiency and innovative thinking. Performs other duties as assigned. Required Qualifications
Bachelor of Science or healthcare related field or equivalent combination of education and related experience. Previous Research, Medical, and/or Pharmacy experience SOCRA - Certified Clinical Research Professional Preferred Qualifications
Pharmacy Technician MN ASHP - Investigational Drug Services Certificate CITI - Good Clinical Practice Certification Additional Requirements
ASHP - Investigational Drug Services Certificate CITI - Good Clinical Practice Certification EEO Statement
EEO/Vet/Disabled: All qualified applicants will receive consideration without regard to any lawfully protected status
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The Clinical Research Specialist is responsible for providing critical logistical support for the successful operation of investigational medication clinical trials conducted throughout the M Health Fairview system. This position collaborates with a variety of M Health departments and study team members to drive high-quality participant medication safety, quality assurance, customer service, process improvement, investigational dispensing, and regulatory compliance. Responsibilities
Communicate with principal investigators, trial coordinators/research assistants, study monitors, and pharmacists to provide technical direction and assistance with clinical research protocol management. Create and maintain electronic trial builds containing study summary, protocol, dispensing procedures, dispensing checklist, fee/billing schedules and other materials specific to each clinical trial. Educate and train internal/external pharmacy staff on dispensing procedures related to specific protocols. Act as a general educational and technical resource to students, staff, and interdisciplinary members of the study team. Collaborate with clinical research staff to prepare internal dispensing guidelines for internal and external departmental use. Participate in investigational medication preparation/dispensing, completion of study documentation, and detailing of protocol related activities according to federal, state, and departmental regulations and standard operating procedures. Communicate with interdisciplinary study team members to ensure appropriateness of trial orders, investigational product management, adherence to protocols, and compliance with any other regulatory or departmental initiatives as appropriate. Perform accountability for the receipt, storage, distribution, and sterile/non-sterile preparation of investigational medications, supplies, and products as specified per study protocol. Maintain proficiency in the skills and theory of the practice of clinical research pharmacy by reviewing literature, attending in-services, seminars, conferences, and actively participating in department clinical research meetings and activities. Participate in regulatory, quality assurance and process improvement activities as the need arises. Organization Expectations
Demonstrates ability to provide care or service adjusting approaches to reflect developmental level and cultural differences of population served. Partners with patient care giver in care/decision making. Communicates in a respectful manner. Ensures a safe, secure environment. Individualizes plan of care to meet patient needs. Modifies clinical interventions based on population served. Provides patient education based on assessment of learning needs of patient/care giver. Fulfills all organizational requirements and completes all required learning relevant to the role. Complies with and maintains knowledge of all relevant laws, regulations, policies, procedures and standards. Fosters a culture of improvement, efficiency and innovative thinking. Performs other duties as assigned. Required Qualifications
Bachelor of Science or healthcare related field or equivalent combination of education and related experience. Previous Research, Medical, and/or Pharmacy experience SOCRA - Certified Clinical Research Professional Preferred Qualifications
Pharmacy Technician MN ASHP - Investigational Drug Services Certificate CITI - Good Clinical Practice Certification Additional Requirements
ASHP - Investigational Drug Services Certificate CITI - Good Clinical Practice Certification EEO Statement
EEO/Vet/Disabled: All qualified applicants will receive consideration without regard to any lawfully protected status
#J-18808-Ljbffr