Job Description

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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