PGY-2 Investigational Drug Services | Department of Pharmacy Services | UC Davis Health

ASHP Residency Directory listing

University of California Davis Medical Center PGY2 Investigational Drugs and Research Pharmacy Residency Purpose

PGY2 residency programs build upon Doctor of Pharmacy (PharmD) education and PGY1 pharmacy residency training to develop pharmacist practitioners with knowledge, skills, and abilities as defined in the educational competency areas, goals, and objectives for advanced practice areas. Residents who successfully complete PGY2 residency programs are prepared for advanced patient care or other specialized positions, and board certification in the advanced practice area, if available.

Program Overview

The Investigational Drugs and Research Pharmacy Residency at the University of California, Davis Medical Center, is a one-year, PGY2 specialty residency in Investigational Drug Services and Research Pharmacy Residency. The residency is supported by the Department of Pharmacy.

The Investigational Drug Services (IDS) is a strong, well-established, and progressive center of excellence at the UC Davis Medical Center. The IDS manages investigational products for a robust portfolio of Phase I, II, and III studies which are conducted through the UC Davis Medical Center hospital, hospital-based clinics, Alpha Stem Cell Clinic, and UC Davis Comprehensive Cancer Center. UC Davis Medical Center is a Level 1 Trauma Center located on the main Sacramento health campus which also houses the CIRM awarded UC Davis Alpha Stem Cell Clinic, the Mind Institute, and the UC Davis Comprehensive Cancer Center. The UC Davis Comprehensive Cancer Center is a NCI-designated Comprehensive Cancer Center as well as a member of the National Comprehensive Cancer Network (NCCN). As an institution, UC Davis Medical Center is within the top recipients for NIH funding, with individual researchers within the top percentage of recipients. At UC Davis Medical Center, investigational products (also known as study drugs) are dispensed from various pharmacy locations to serve a highly diverse catchment area of 19 inland northern California counties, as well as patients coming elsewhere in California and many surrounding states. The Investigational Drugs and Research Pharmacy Residency will provide each resident with a comprehensive training and robust educational experience in research pharmacy services.

UC Davis Medical Center and Pharmacy Services

UC Davis Medical Center is a major academic health center located in Sacramento, California. The Department of Pharmacy Services recruits, hires, and trains caregivers to provide progressive pharmacy services as collaborative team members to support optimal patient outcomes.
More about the Department of Pharmacy Services can be found on our Webpage

Program Design

The UC Davis Medical Center PGY2 Investigational Drugs and Research Pharmacy Residency is designed to meet the educational goals and objectives as outlined by the ASHP Standard.

Educational Outcomes Required by the Accreditation Standard:

R1. Patient Care
R2. Advancing Practice and Improving Patient Care
R3. Research Protocols and Regulations
R4. Leadership and Management
R5. Teaching, Education, and Dissemination of Knowledge
Electives may be added based on available resources and resident interest

Program Structure

The PGY2 Investigational Drugs and Research Pharmacy Residency is a full-time, one-year commitment, beginning on July 1 and ending on June 30. Clearance to start work by UC Davis Health must be completed prior to the established residency start date.

Example Resident Schedule (subject to change):

Required Learning Experiences	Type of Experience	Overview
Orientation and IDS Training	Block (1 month)	Orientation to UC Davis Medical Center, pharmacy residency program policies and the specific residency program. Training for IDS Pharmacy Coverage and Department of Pharmacy Service (DPS) Evening Support will occur during this time. Duration may be adjusted based on the resident’s previous experience and knowledge of UC Davis Medical Center.
Investigational Drug Service I	Block (1 month)	Provides introduction to processes related to dispensing and managing investigational drugs, ERX development, and clinical trials in the non-oncology IDS Pharmacy.
Investigational Drug Service Cancer Center I	Block Block (1 month)	Provides introduction to processes related to dispensing and managing investigational drugs, ERX development, and clinical trials in the IDS Cancer Center Pharmacy. The resident will also attend at least one half-day of a medical oncology clinic (e.g. lung cancer clinic) with a PI to provide an overview of the ambulatory workflow in oncology and clinical trial patient care and observe the relationship to IDSCC operations.
Protocol Management I	Block (1 month)	This rotation immerses the resident in the day-to-day management of the clinical trials portfolio, from feasibility assessment to fee schedule development to study start-up as well topic discussions about the Medicare coverage analysis, budgets, contracts, and finance.
Protocol Management II	Block (1 month)	This learning experience builds upon Protocol Management I to provide the resident with experience in managing the study throughout its life cycle through document, technology applications, and workflow modifications.
Cancer Center Infusion	Block (1 month)	Cancer Center Infusion will focus on the fundamentals of the Infusion Pharmacy workflow, with an emphasis on oversight of preparation and dispensing of chemotherapy and investigational drugs. The resident will be introduced to the process of reviewing and processing of chemotherapy orders; management and prevention of chemotherapy-related toxicities; medication safety/preventing chemotherapy errors; patient counseling.
Pediatric Oncology	Block (1 month)	Clinical rotation with the pediatric oncology outpatient clinic and infusion pharmacy services. The focus of this rotation will be the management of care for pediatric patients enrolled on clinical trials and patients treated per trial.
Ambulatory Care Clinic (non-Oncology)	Block (1 month) (To run concurrently with another learning experience)	Ambulatory clinic rotation in a setting with robust pharmacy services and clinical trial study teams. Clinic experiences will be assigned based on the current clinical trial portfolio and ambulatory care service pharmacists to provide exposure to patient populations, clinic workflow, clinical pharmacist services, recruitment, retention, and treatment workflows, study team member roles, and clinical trials treatment. Clinic options may include, but are not limited to: Infectious Disease, Pulmonary Critical Care, Physical Medicine & Rehab, Neurology, or Transplant.
Scholarship and Precepting	Block (1 month)	This rotation provides the resident with the opportunity to engage in precepting with other learners (students or residents) and to develop their precepting skills. To run concurrently with another learning experience.

Required Longitudinal Learning Experiences

• Research/QI Project (including 10 days for research divided into 2-5 day blocks + 3 floating project days)
• Grand Rounds
• RPS Performance Improvement Project
• IDS Pharmacy Practice Management
• Protocol Development
• IDS BEACON
• Institutional Review Board (IRB)/Regulatory Affairs
• Dept of Pharmacy Services Staffing (including DPS Evening/Block Staffing and Pharmacy Coverage on weekends)

Elective Experiences

• Alpha Stem Cell Clinic (ASCC)
• Advanced ASCC
• Cellular Therapy Service
• Inpatient Medical Oncology
• Protocol Development
• Drug Development
• Oncology Specialty Pharmacy
• Research Quality and Safety
• IDS Pharmacy Practice Management

Elective length may vary if multiple learning experiences are scheduled to fulfill a one-month period (e,g, two electives or one week of required rotation plus an elective). Additional elective rotations can be developed based on the clinical trial portfolio available at the time, and the interests of the resident. Any such modification will be noted in the customized development plan.

Additional Opportunities

Based on interest, the clinical trial portfolio, and current therapeutic and trial management advancements, the resident may choose to attend the quarterly Molecular Tumor Board, attend Clinical and Translational Science Center (CTSC) education courses as applicable, and shadow at the Clinical Research Center (CCRC) and the Office of Clinical Research (OCR). Other opportunities identified can be attended with approval from the RPD. These are optional experiences that may be incorporated into the residency year based on resident interest to increase their foundational knowledge and augment their self-driven, independent, professional development.

Assignment of Education Goals and Objectives to Specific Learning Experiences – see learning experiences and objectives outlined in PharmAcademic.

The UC Davis Medical Center PGY2 Investigational Drugs and Research Pharmacy Residency is designed to provide the resident with a broad range of experiences in a variety of practice settings. Required learning experiences have been designed to meet the content requirements, as outlined in the ASHP PGY2 Investigational Drugs and Research Pharmacy Residency required competency areas, goals and objectives and to provide exposure to the key investigational drugs and research pharmacy residency topic references.

UC Davis Medical Center PGY2 Investigational Drugs and Research Resident’s Role in Teaching:
UC Davis Medical Center offers many opportunities for both clinical and didactic teaching. The resident will be responsible for assisting preceptors with clerkship teaching for University of California, San Francisco pharmacy students and UC Davis Medical Center PGY1 pharmacy residents. Should the rotations overlap, the resident will assume the primary preceptor role for any UCSF pharmacy students during their last IDS or IDSCC learning experience. The resident will engage in precepting and learning activities during the Scholarship and Precepting Learning Experience.

The PGY2 Investigational Drug and Research Resident can also participate in didactic teaching for clinical research coordinators, study teams, nurses, and pharmacist. In addition, the PGY2 Investigational Drugs and Research Pharmacy Resident may choose to participate in academic teaching, as requested by regional schools of pharmacy, with the approval of the PGY2 Investigational Drugs and Pharmacy Research Residency Program Director.

Residency Research Project:
All UC Davis Medical Center PGY2 residents are required to complete a research project during their residency and present their research at a regional, state, or national conference. In preparation for conducting their research project, the resident will be complete UC Davis Health IRB-required training and certification. The resident will prepare a project proposal, which will be reviewed and approved by the Pharmacy Research Oversight Committee. The resident will also submit their project to the Pharmacy and Therapeutics Committee and the IRB for approval before embarking on their research. The resident will also be provided opportunities to present their research at one or more regional pharmacy residency conferences. Upon completion of the project, the resident will be required to summarize their research project in a manuscript and submit for publication. This will occur during the Research/QI Project Learning Experience.

Grand Rounds: The resident will be required to prepare an ACPE accredited pharmacy grand rounds (or equivalent) presentation on a topic pertaining to emerging therapies, clinical trials, or investigational drugs, based on the resident’s interests and per department needs assessment. A presentation, to an external department or entity, that is deemed to be equivalent may be permitted as an alternative. This will occur during the Grand Rounds Learning Experience.

Committee Assignments:
The PGY2 Investigational Drug and Research residents will rotate in quarterly assignments through at least four (4) of the following UC Davis Health Committees: 1) Data Safety Monitoring Committee (DSMC); 2) Medication Error Reduction Committee (MERC); 3) UC IDS Pharmacy Collaborative Team; 4) Hematology Oncology Pharmacist Association (HOPA) IDS Special Interest Group (SIG); 5) BEACON Clinical Trials Workgroup; 6) Society of Research Clinicians (SRC). The resident will be assigned various activities and projects during each committee rotation. Activities may include specific projects, coordinating agendas and minutes, and reviewing documents. The purpose of the resident’s committee involvement is to ensure the resident gains exposure to the IDS pharmacist’s role in activities related to quality-improvement, study management on a site level, practice standardization, understanding the impact of clinical trials in standard of care practice, medication safety, safe handling of hazardous drugs, guideline development, and assessment/implementation of technology and automation within the institution and pharmacy department. This is part of the Longitudinal IDS Pharmacy Practice Management learning experience.

Professional Development:
The PGY2 Investigational Drug and Research resident is encouraged to maintain an active role in pharmacy professional organizations. The resident is required to attend the Pharmacy Research Summit and is strongly encouraged to join a professional organization with a mission, initiative, or concerted effort to further research pharmacy services (RPS) or Investigational Drug Services (IDS) practices. The resident is expected to complete the ASHP Investigational Drug Services Certificate program or attend a second professional conference to further develop their clinical interests and areas of research. The resident will be provided with some financial support from the institution and professional leave time to facilitate participation in professional development activities. This is captured in the Investigational Drug Service Cancer Center I and Longitudinal IDS Pharmacy Practice Management learning experiences.

Pharmacy Department Service:
The PGY2 Investigational Drug and Research resident will be expected to provide approximately 400 hours of pharmacy department service. This expectation will be met primarily by providing weekend DPS pharmacy coverage (272 hours) approximately every 3rd weekend plus one major holiday (Thanksgiving, Christmas Eve, or New Years) and one minor holiday as well as providing 120 hours of evening Department of Pharmacy support. This is accomplished through the DPS Pharmacy Coverage and DPS Evening/Block Staffing learning experiences in the assigned areas.

Required Competencies:
Residents function as licensed pharmacists in patient care activities. As such, minimum knowledge in a variety of areas must be assured. Within one month of starting the Residency, the resident must complete competencies required of all clinical pharmacists, including Basic Life Support (BLS) (and if required for staffing requirements, Advanced Cardiac Life Support (ACLS)). For residents who completed their PGY1 Pharmacy Residency at UC Davis Medical Center, renewal during the PGY2 year will be as outlined by the institution renewal cycles and requirements for competency.

Resident Portfolio:
Each resident must maintain a portfolio containing all information from the residency year including but not limited to: copies of papers and projects done during rotations, lectures given, and other miscellaneous deliverables. The portfolio shall be maintained in PharmAcademic and/or in the resident’s folder on the Pharmacy Department shared drive.

Salary:
$77,000 annual salary. (Note that this salary includes a stipend for professional meeting registration(s), travel accommodations, and transportations for at least one off-site meeting; and completion of the ASHP IDS certificate and costs associated with a virtual professional meeting.)

Benefits:
Health, Dental and Vision insurance for resident and dependents; vacation, sick leave and professional leave as outlined in the Pharmacy Resident Manual, usually 21 days of PTO, 14 paid holidays, 6 extended sick days and 4 days of professional development leave. Travel funds (~$3000) are included in the base salary. There is a stipend for Pharmacy Department scrubs.

Use of PTO must be arranged in advance with the RPD. Preceptors must be notified well in advance of the learning experience.

Resident Personnel Policies:
The following policies can be located in the Pharmacy Resident Personnel Manual

• Resident Qualifications
• Early Commitment Policy
• Pre-employment drug testing
• Health insurance and Benefits
• California pharmacist licensure requirement
• Moonlighting
• Duty hours/tracking of duty hours
• Professional, family, and extended leave policies
• Dismissal policy and consequences of failure to progress

Criteria for Successful Completion of the PGY2 Investigational Drugs & Research Pharmacy Residency

Requirements / Activity

• California Pharmacist Licensure Per Pharmacy Resident Manual Policy
• A minimum of 52 weeks of training inclusive of standard vacation, professional, and sick leave
• Completion of assigned competencies, including BLS (+ ACLS if required for staffing areas)
• Completion of CITI and GCP training during Orientation
• Complete requisite training during Orientation to independently staff
• Completion of all required rotations/learning experiences
• Presentation of Research/QI Project at a regional, state, or national conference
• Submit Research/QI Project manuscript to selected journal
• Complete and deliver Grand Rounds (or equivalent) to selected audience
• Completion of staffing contributions as outlined by the residency program description
• Active participation in committee meetings and projects as assigned
• Active participation in the annual program QI meeting
• Attendance at the Research Pharmacy Summit
• Attendance at second pharmacy conference (to be in area of resident interest)
• Completion of ASHP IDS certificate program
• Achievement for the Residency” of at least 80% of program objectives. No objectives may have a final assessment of “Needs Improvement.
  (Program objectives may be ACHR by the RPD throughout the year and/or at resident closeout.)
• Resident closeout completed in PharmAcademic, confirming all tasks are completed

Pharmacy Residency training programs at UC Davis Health are conducted under the licensed entity within UC Davis Health which is UC Davis Medical Center.