Clinical Research Pharmacist

The Investigational Drug Services (IDS) Pharmacy is seeking a dedicated Clinical Research Pharmacist to join our growing team. As an integral part of the research ecosystem, you will play a pivotal role in advancing clinical trials as we open a newly designed, state-of-the-art facility to expand our capacity for supporting innovative research. Located just 2.5 miles from the M Health Fairview medical complex, the new pharmacy offers convenient parking and excellent access to transit options. Join us in shaping the future of clinical research within the M Health Fairview ecosystem. This benefits eligible position is a 1.0FTE (80 hours/2 weeks) on the day shift!

The Clinical Research Pharmacist is essential to managing investigational drug studies, ensuring the safe and efficient operation of clinical trials. This role is responsible for reviewing protocols, managing investigational medications, ensuring compliance with regulatory standards, and collaborating with interdisciplinary teams to support research and patient care. By serving as an expert resource, the Clinical Research Pharmacist helps advance innovative therapies and uphold the integrity of clinical research operations.

Clinical Trial Review and Management

• Review and interpret investigational drug trial protocols and associated documentation.
• Develop and maintain dispensing guidelines and other operational procedures to support trial success.
• Act as a liaison between investigators, research coordinators, and pharmacy staff to ensure effective trial management.

Investigational Medication Management

• Coordinate the preparation, distribution, and accountability of investigational medications.
• Work with Epic Willow and Beacon teams to create and manage order builds for investigational drug products.
• Maintain Vestigo trial builds with study summaries, protocols, dispensing checklists, and regulatory documentation.

Training and Education

• Provide protocol-specific training and education to internal and external pharmacy staff.
• Educate pharmacy staff across the system about research processes and study requirements.
• Serve as a clinical resource for students, staff, and interdisciplinary groups involved in clinical trials.

Regulatory Compliance and Documentation

• Ensure adherence to all regulatory standards for investigational drug handling and trial protocols.
• 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 operations.

Operational Support and Collaboration

• Provide clinical pharmacy services to trial participants, including medication dispensing, patient reviews, and therapy oversight.
• Partner with interdisciplinary teams and sponsors to address study needs and ensure smooth trial operations.
• Oversee investigational drug supply management, ensuring availability for all research protocols.

Professional Development

• Stay current in investigational pharmacy practice through literature reviews, seminars, and department meetings.
• Maintain required certifications and participate in ongoing training to ensure expertise in research pharmacy operations.

Required

• PharmD or bachelor’s degree in pharmacy.
• Minnesota Pharmacist License.

Preferred

• Completion of ASHP-accredited PGY1 or PGY2 Pharmacy Residency, or equivalent hospital/other pharmacy experience.
• Experience in investigational drug services or clinical research pharmacy.
• Board Certified Oncology Pharmacist (BCOP) certification or equivalent experience.

Additional Requirements (must be obtained or completed within specified timeframe):

• ASHP Investigational Drug Services Certification – within one year of hire.
• CITI Good Clinical Practice Certification – within 30 days of hire.