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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