Clinical Pharmacist Specialist - Research Pharmacy
University of Michigan
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Job summary
Michigan Medicine, part of the University of Michigan, seeks a Clinical Pharmacist Specialist for the Research Pharmacy to oversee investigational drug operations, start-up planning, and dispensing workflows. The role ensures regulatory compliance, accurate documentation, and collaboration with investigators and sponsors across trials.
The position emphasizes education of learners, quality improvement leadership, and potential involvement in diverse therapeutic areas beyond hematology/oncology
Qualifications
- Pharmacy degree from an accredited college and current licensure in Michigan or eligibility within 60 days.
- Experience with investigational drug services and research pharmacy operations preferred.
- Ability to manage regulatory compliance and maintain rigorous documentation.
Responsibilities
- Lead pharmacis t on delegation of authority and support investigational studies.
- Collaborate with investigators, coordinators, sponsors, and IT teams to support start-up and closeout.
- Develop workflows and order sets; ensure protocol feasibility and adherence.
- Review documents, verify orders, and perform sterile and non-sterile compounding as needed.
- Manage storage, dispensing, accountability, and return/destruction of investigational products.
- Provide on-call support; mentor students and residents; participate in quality initiatives.
Skills
Education
Tools
Job description
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
The Research Pharmacy at Michigan Medicine is a nationally recognized service dedicated to advancing drug-related research and innovative care. The service supports a diverse portfolio of more than 600 inpatient and outpatient clinical trials across early and late phase development and many therapeutic areas, as well as a large cohort of expanded access (compassionate use) cases.
The Clinical Pharmacist Specialist in Research Pharmacy plays a critical role in translating research protocols into safe and reliable pharmacy operations. This position is responsible for the comprehensive management of investigational drugs, including study start-up, dispensing workflow development, medication preparation and dispensing, accountability, documentation, and study closeout. The pharmacist serves as a key liaison among principal investigators, study teams, sponsors, and pharmacy staff, ensuring clear communication, regulatory compliance, and continuity of care for research participants.
In addition to study management and operational responsibilities, this role actively supports Michigan Medicine's tripartite mission through the education and mentorship of pharmacy learners and staff, and through the leadership of quality improvement and practice advancement initiatives.
This pharmacist will primarily support hematology/oncology clinical trials. However, the individual may be assigned studies across any therapeutic area (including non-hematology/oncology trials) based on the needs of the service.
- Serve as the Lead Pharmacist on the Delegation of Authority Log for assigned portfolio of investigational drug studies and/or expanded access cases.
- Collaborate with principal investigators, study coordinators, nurses, sponsors, clinical research organizations, information technology teams, and pharmacy colleagues to support study start-up, ongoing operations, and closeout activities. Participate in planning meetings, site initiation visits, monitoring visits, audits, and inspections.
- Extract, critically analyze, and synthesize pharmacy relevant information from clinical trial protocols, investigator's brochures, pharmacy manuals, and related study documents to develop clear, practical pharmacy workflows, Epic/MiChart ERXs, order sets, Beacon builds, Vestigo builds, hazardous drug assessments, and dispensing guidelines.
- Reconcile sponsor requirements with Michigan Medicine policies, Research Pharmacy standard operating procedures, clinical practice standards, and regulatory requirements. Assess protocol feasibility and alignment with local practice; identify discrepancies and barriers to activation; and independently resolve, negotiate, and formally document clarifications with sponsors to ensure compliant trial conduct.
- Review pharmacy documents and order builds to ensure accuracy, completeness, safety, and adherence to standards.
- Perform pharmacist review, verification, preparation, and dispensing of investigational, commercial, and standard-of-care medications, ensuring appropriateness, safety, and protocol compliance. Perform and check non-sterile and sterile compounding.
- Communicate with patients, research teams, and clinical teams to support timely initiation of therapy and prevent delays or disruptions in care.
- Ensure appropriate receipt, storage, preparation, dispensing, accountability, and return or destruction of investigational products.
- Identify, document, and escalation protocol deviations, medication-related issues, or safety concerns, and collaborate with study teams on corrective and preventive actions.
- Determine appropriate recharge fees for pharmacy services and ensure appropriate billing of pharmacy-related charges.
- Conduct ancillary reviews of protocols and study applications for IRBMED and other support units.
- Provide on-call support for Research Pharmacy, including weekend and holiday coverage.
- Contribute to the training and mentorship of pharmacy students, interns, residents, and new team members. Serve as a preceptor for Doctor of Pharmacy students and PGY1/PGY2 pharmacy residents. Develop and oversee learner projects. Evaluate learners/trainees and provide constructive feedback.
- Participate in or lead committees, workgroups, quality improvement initiatives, policy and procedure development, strategic projects, cost-saving or revenue-generating initiatives, scholarly activities, staff training, and continuing education.
- Perform other duties as assigned.
- Skills and Competencies
- Strong problem-solving skills with the ability to work independently, creatively, and proactively with limited or incomplete information.
- Demonstrated ability to communicate effectively and collaborate with interdisciplinary teams, exhibiting integrity, empathy, and emotional intelligence.
- Ability to manage multiple competing priorities with accuracy, flexibility, and dependability.
- Demonstrated experience leading, implementing, and monitoring projects involving multiple stakeholders.
- Demonstrated ability to independently review and synthesize large, complex amounts of information into practical workflows.
- Perform all duties in compliance with Good Clinical Practice; FDA regulations; Joint Commission standards; applicable laws and regulations; Board of Pharmacy regulations; and Michigan Medicine policies.
- Maintain robust documentation in alignment with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, etc.).
- Doctor of Pharmacy Degree from an accredited College of Pharmacy or equivalent combination of education and experience.
- Current licensure as a registered pharmacist by the State of Michigan Board of Pharmacy and a Michigan Controlled Substance License to practice pharmacy in the State of Michigan, or eligibility to become licensed within 60 days of employment start date.
- Able to perform all Duties and Responsibilities.
- Experience providing clinical care to hematology/oncology and research patients, with preference for experience in pediatric oncology, bone marrow transplant (BMT), and cell or gene therapy programs.
- Prior professional experience in research pharmacy, investigational drug services, or handling investigational drugs.
- Completion of a PGY2 residency in Oncology Pharmacy or Investigational Drugs and Research Pharmacy, or an equivalent combination of education, training, and experience.
- Minimum of 2 years of pharmacist experience in an acute care or health system pharmacy practice setting.
- Experience with Epic Beacon, including the build, maintenance, or review of chemotherapy treatment plans and research related orders.
- Experience with chemotherapy preparation and hazardous drug handling.
- Experience serving as a preceptor for PharmD students, interns, and pharmacy residents.
- Board of Pharmacy Specialties (BPS) certification in Pharmacotherapy or Oncology Pharmacy.
This position will report to the Manager of Research Pharmacy. The position may receive functional supervision from Research Pharmacy Team Leads.
Pharmacists provide functional supervision of pharmacy technicians, residents, and students.
Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.
- Excellent medical, dental and vision coverage effective on your very first day
- 2:1 Match on retirement savings
- Paid Time Off
- Opportunities to earn continuing education credits at in-house education programs
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.
The schedule for this position includes day shifts and on-call responsibilities. Work outside of standard business hours may be required to meet operational and patient care needs.
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Job openings are posted for a minimum of seven calendar days. This opening may be removed from posting boards and filled any time after the minimum posting period has ended.
The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.
Job Opening ID
284920
Working Title
Clinical Pharmacist Specialist - Research Pharmacy
Job Title
Clinical Pharmacist Specialist
Work Location
Michigan Medicine - Ann Arbor
Ann Arbor, MI
Modes of Work
Onsite
Full/Part Time
Full-Time
Regular/Temporary
Regular
FLSA Status
Exempt
Organizational Group
Um Hospital
Department
MM Research Pharmacy
Posting Begin/End Date
10/27/2026 - 11/19/2026
Career Interest
Patient Care Services
Pharmacy
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