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Job Overview

**Job Summary:** 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.

Job Expectations:

+ 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 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, as applicable:

+ Demonstrates ability to provide care or service adjusting approaches to reflect developmental level and cultural differences of population served.

+ Communicates in a respective manner.

+ Ensures a safe, secure environment.

+ Fulfills all organizational requirements.

+ Completes all required learning relevant to the role.

+ Complies with and maintains knowledge of all relevant laws, regulation, policies, procedures and standards.

+ Fosters a culture of improvement, efficiency and innovative thinking.

+ Performs other duties as assigned.

Minimum Qualifications to Fulfill Job Responsibilities:

Required

Education

Baccalaureate degree in science or healthcare related field **OR** equivalent combination of education/related experience.

Experience

Previous Research, Medical, **AND/OR** Pharmacy experience

Preferred

Education

SOCRA – Certified Clinical Research Professional

License/Certification/Registration

Registered **OR** eligible to become registered as a Pharmacy Technician with the MN State Board of Pharmacy

Experience

Sterile compounding (USP 797) experience

**Additional Requirements** (to be completed within 3 months of hire)

+ CITI – Good Clinical Practice Certification

+ Fairview USP 795 Training

+ Fairview USP 797 Training

+ Fairview USP 800 Training

+ IDS Internal Competency Training

Benefit Overview

Fairview offers a generous benefit package including but not limited to medical, dental, vision plans, life insurance, short-term and long-term disability insurance, PTO and Sick and Safe Time, tuition reimbursement, retirement, early access to earned wages, and more! Please follow this link for additional information: https://www..fairview.org/careers/benefits/noncontract

Compensation Disclaimer

An individual's pay rate within the posted range may be determined by various factors, including skills, knowledge, relevant education, experience, and market conditions. Additionally, our organization prioritizes pay equity and considers internal team equity when making any offer. Hiring at the maximum of the range is not typical. If your role is eligible for a sign-on bonus, the bonus program that is approved and in place at the time of offer, is what will be honored.

EEO Statement

EEO/Vet/Disabled: All qualified applicants will receive consideration without regard to any lawfully protected status