Clinical Research Pharmacist

Job Overview The Clinical Research Pharmacist serves as an oncology-focused clinical expert within Fairview’s Investigational Drug Services program, supporting the safe and compliant operation of cancer clinical trials across outpatient infusion, inpatient, and research-dedicated settings. This role pairs direct clinical trial pharmacy practice with protocol standard-of-care reconciliation, cross-site coordination for investigational and protocol-directed commercial medications, and partnership with Epic Beacon and sponsor teams to translate oncology protocols into operationally sound workflows. Working alongside the broader Investigational Drug Services team, the Clinical Research Pharmacist helps build a durable long-term model for oncology clinical trial support while advancing patient care and the integrity of research operations. Location: UMMC Mayo Building 420 Delaware St SE Job Expectations: Clinical Trial Review and Management Review and interpret investigational drug trial protocols and associated documentation, with particular attention to oncology regimens spanning infusion and oral therapies. Perform protocol standard-of-care reconciliation: identify divergence between protocol-directed monitoring, dosing, or supportive care and established institutional practice, and facilitate resolution with sponsor clinical teams and investigators. Contribute pharmacy input during study startup and feasibility review, including site-of-care routing recommendations based on trial phase, acuity of care requirements, and operational workflow fit. Develop and maintain dispensing guidelines and operational procedures that support trial success across clinical settings. Act as a liaison between investigators, research coordinators, pharmacy staff, and sponsor clinical teams to ensure effective trial management. Investigational Medication Management Coordinate the preparation, distribution, and accountability of investigational medications, including oncology infusion and oral therapies. Partner with Epic Willow and Beacon teams to author and validate research treatment plan builds and investigational medication order sets, resolve non-standard protocol elements during EHR build, and participate in the treatment plan approval chain alongside the study team. Maintain Vestigo trial builds with study summaries, protocols, dispensing checklists, and regulatory documentation. Coordinate protocol-directed commercial standard-of-care medications, including formulary review, non-formulary sourcing, and availability alignment across dispensing sites. Provide clinical judgment on interactions between investigational products and concurrent standard-of-care oncology therapies. Training and Education Provide protocol-specific training and education to pharmacy staff across investigational drug services, infusion centers, and inpatient pharmacies. Educate pharmacy staff system-wide about oncology research processes, protocol requirements, and operational handoffs. Serve as a clinical resource for pharmacy students, oncology residents, and interdisciplinary groups involved in clinical trials. Regulatory Compliance and Documentation Ensure adherence to all regulatory standards for investigational drug handling and trial protocols, including FDA 21 CFR Part 312, ICH-GCP, and applicable state board requirements. Manage all study files to maintain regulatory readiness in compliance with FDA and GCP guidelines. Participate in quality assurance initiatives and process improvements to enhance research pharmacy operations. Operational Support and Collaboration Coordinate across investigational drug services, infusion centers, and inpatient pharmacies to align dispensing and administration for each protocol with the most appropriate clinical setting, considering trial phase, patient acuity, and workflow fit. Provide clinical pharmacy services to trial participants, including medication verification, patient review, and therapy oversight. Partner with internal stakeholders and sponsors to negotiate protocol clarifications or exceptions where institutional practice and protocol requirements conflict. Oversee investigational drug supply management, ensuring availability for all research protocols. Participate in oncology-focused standing committees, workgroups, and ad-hoc discussions to represent investigational drug services and clinical trial pharmacy perspectives. Partner with Investigational Drug Services leadership and the broader research pharmacy team to advance long-term support models for oncology clinical trials as the program matures. Professional Development Stay current in oncology and investigational pharmacy practice through literature reviews, seminars, and department meetings. Maintain required certifications and participate in ongoing training to sustain expertise in oncology research pharmacy operations. 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 all relevant laws, regulation and policies Performs other duties as assigned. Required Qualifications PharmD OR bachelor’s degree in pharmacy. Minnesota Pharmacist License. Preferred Qualifications Demonstrated oncology pharmacy experience, ideally spanning both infusion and oral oncology practice. Board Certified Oncology Pharmacist (BCOP) certification or equivalent oncology practice experience. Completion of ASHP-accredited PGY-2 Oncology Pharmacy Residency, PGY-1 residency with substantive oncology experience, or equivalent hospital/pharmacy experience. Prior experience in investigational drug services, clinical research pharmacy, or oncology clinical trial operations. Experience with Epic Beacon research treatment plan build and oncology EHR order set development. Additional Requirements (must be obtained or completed within specified timeframe): CITI Good Clinical Practice Certification – within 30 days of hire. ASHP Investigational Drug Services Certification – within one year of hire. 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 foradditional 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 The Clinical Research Pharmacist serves as an oncology-focused clinical expert within Fairview's Investigational Drug Services program, supporting the safe and compliant operation of cancer clinical trials across outpatient infusion, inpatient, and research-dedicated settings. This role pairs direct clinical trial pharmacy practice with protocol standard-of-care reconciliation, cross-site coordination for investigational and protocol-directed commercial medications, and partnership with Epic Beacon and sponsor teams to translate oncology protocols into operationally sound workflows. Working alongside the broader Investigational Drug Services team, the Clinical Research Pharmacist helps build a durable long-term model for oncology clinical trial support while advancing patient care and the integrity of research operations. Location: UMMC Mayo Building 420 Delaware St SE Job Expectations: Clinical Trial Review and Management Review and interpret investigational drug trial protocols and associated documentation, with particular attention to oncology regimens spanning infusion and oral therapies. Perform protocol standard-of-care reconciliation: identify divergence between protocol-directed monitoring, dosing, or supportive care and established institutional practice, and facilitate resolution with sponsor clinical teams and investigators. Contribute pharmacy input during study startup and feasibility review, including site-of-care routing recommendations based on trial phase, acuity of care requirements, and operational workflow fit. Develop and maintain dispensing guidelines and operational procedures that support trial success across clinical settings. Act as a liaison between investigators, research coordinators, pharmacy staff, and sponsor clinical teams to ensure effective trial management. Investigational Medication Management Coordinate the preparation, distribution, and accountability of investigational medications, including oncology infusion and oral therapies. Partner with Epic Willow and Beacon teams to author and validate research treatment plan builds and investigational medication order sets, resolve non-standard protocol elements during EHR build, and participate in the treatment plan approval chain alongside the study team. Maintain Vestigo trial builds with study summaries, protocols, dispensing checklists, and regulatory documentation. Coordinate protocol-directed commercial standard-of-care medications, including formulary review, non-formulary sourcing, and availability alignment across dispensing sites. Provide clinical judgment on interactions between investigational products and concurrent standard-of-care oncology therapies. Training and Education Provide protocol-specific training and education to pharmacy staff across investigational drug services, infusion centers, and inpatient pharmacies. Educate pharmacy staff system-wide about oncology research processes, protocol requirements, and operational handoffs. Serve as a clinical resource for pharmacy students, oncology residents, and interdisciplinary groups involved in clinical trials. Regulatory Compliance and Documentation Ensure adherence to all regulatory standards for investigational drug handling and trial protocols, including FDA 21 CFR Part 312, ICH-GCP, and applicable state board requirements. Manage all study files to maintain regulatory readiness in compliance with FDA and GCP guidelines. Participate in quality assurance initiatives and process improvements to enhance research pharmacy operations. Operational Support and Collaboration Coordinate across investigational drug services, infusion centers, and inpatient pharmacies to align dispensing and administration for each protocol with the most appropriate clinical setting, considering trial phase, patient acuity, and workflow fit. Provide clinical pharmacy services to trial participants, including medication verification, patient review, and therapy oversight. Partner with internal stakeholders and sponsors to negotiate protocol clarifications or exceptions where institutional practice and protocol requirements conflict. Oversee investigational drug supply management, ensuring availability for all research protocols. Participate in oncology-focused standing committees, workgroups, and ad-hoc discussions to represent investigational drug services and clinical trial pharmacy perspectives. Partner with Investigational Drug Services leadership and the broader research pharmacy team to advance long-term support models for oncology clinical trials as the program matures. Professional Development Stay current in oncology and investigational pharmacy practice through literature reviews, seminars, and department meetings. Maintain required certifications and participate in ongoing training to sustain expertise in oncology research pharmacy operations. 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 all relevant laws, regulation and policies Performs other duties as assigned. Required Qualifications PharmD OR bachelor's degree in pharmacy. Minnesota Pharmacist License. Preferred Qualifications Demonstrated oncology pharmacy experience, ideally spanning both infusion and oral oncology practice. Board Certified Oncology Pharmacist (BCOP) certification or equivalent oncology practice experience. Completion of ASHP-accredited PGY-2 Oncology Pharmacy Residency, PGY-1 residency with substantive oncology experience, or equivalent hospital/pharmacy experience. Prior experience in investigational drug services, clinical research pharmacy, or oncology clinical trial operations. Experience with Epic Beacon research treatment plan build and oncology EHR order set development. Additional Requirements (must be obtained or completed within specified timeframe): CITI Good Clinical Practice Certification - within 30 days of hire. ASHP Investigational Drug Services Certification - within one year of hire. $65.79- $92.88 Hourly