Research Pharmacist (Flagstaff)

Arizona Liver Health•Flagstaff, AZ

1d•Onsite

About The Position

Arizona Clinical Trials / Arizona Liver Health is searching for qualified Research Pharmacist candidates in Flagstaff, AZ. Previous Clinical Research experience is not required. The Research Pharmacist will oversee and manage pharmacy operations to ensure compliance with FDA, DEA, state board of pharmacy, and institutional regulations. They will verify the accuracy of medication dispensing, labeling, storage, and accountability logs in accordance with study protocols and Good Clinical Practice (GCP) standards. The role also involves ensuring investigational product (IP) handling procedures, including receipt, storage, preparation, and return/destruction, are compliant with sponsor and regulatory requirements. Regular audits of pharmacy and medication management processes will be conducted for quality control and compliance documentation. The position requires performing study-related pharmacy tasks such as patient compliance, education, and counseling regarding side effect management. The Research Pharmacist will also proactively work with the study team to acquire necessary medications for study enrollment goals. This role includes reviewing and verifying study prescriptions, medication orders, and dosing schedules, preparing, compounding, and dispensing investigational and standard-of-care medications, and maintaining/reconciling drug accountability records. Oversight of temperature monitoring, inventory control, and security of controlled and investigational drugs is also a key responsibility. Additionally, the role involves providing training and guidance to staff on IP handling, storage, and documentation, serving as a resource for clinical staff regarding medication use and regulations, and collaborating with sponsors and CROs. Implementation and development of pharmacy SOPs, identification and resolution of operational issues, and support for study start-up activities are also part of the role. The Research Pharmacist will maintain accurate documentation, participate in protocol reviews, and prepare reports on investigational drug inventory, usage, and compliance.

Requirements

Minimum 1-2 years of experience as a Pharmacist (Clinic, Hospital, Retail, or Research setting) preferred
Excellent communication skills both verbally and in writing
High competency in accessing and analyzing information through various resources to make sound decisions
Capability to critically evaluate and solve problems through various challenges
Proven capability to train pharmacy techs and other personnel on pharmacy procedures and other related areas under the research scope
High efficiency to manage multiple tasks and project timelines
Detail oriented with proven capability to enter accurate data into different systems
Earned Doctor of Pharmacy (PharmD) from an accredited institution is required
Active and unrestricted Pharmacist license issued in the State of Arizona (or reciprocity with another US state)
GCP (Good Clinical Practice) certification required and can be completed upon hire
IATA training required and can be completed upon hire
Must have active and valid documentation and authorization to work in the United States for any employer (work sponsorship and work visa transfer not available)

Nice To Haves

Previous Clinical Research experience is not required.

Responsibilities

Oversee and manage pharmacy operations to ensure compliance with FDA, DEA, state board of pharmacy, and institutional regulations.
Verify accuracy of medication dispensing, labeling, storage, and accountability logs in accordance with study protocols and Good Clinical Practice (GCP) standards.
Ensure investigational product (IP) handling procedures including the receipt, storage, preparation, and return/destruction of product is compliant with sponsor and regulatory requirements.
Conduct regular audits of pharmacy and medication management processes to maintain quality control and compliance documentation.
Perform study related pharmacy tasks - patient compliance, education, counsel regarding side effect management or other per protocol.
Perform other study related tasks as per Pharmacist role.
Proactively work with study team to acquire medications needed for study enrollment goals.
Review and verify all study prescriptions, medication orders, and dosing schedules for accuracy and protocol adherence.
Prepare, compound, and/or dispense investigational and standard-of-care medications as required by each research protocol.
Maintain and reconcile drug accountability records to ensure complete traceability of all study medications.
Oversee temperature monitoring, inventory control, and security of all controlled and investigational drugs.
Provide training and guidance to staff on investigational product handling, storage, and documentation procedures.
Serve as a resource for investigators, research coordinators, and clinical staff regarding medication use, study drug interactions, and pharmacy regulations.
Collaborate with sponsors, CROs, and study monitors to support audits, site qualification , and study initiation visits.
Implement pharmacy SOPs and processes to ensure standardized practices.
Develop new SOPs or processes as needed with colleagues and managers.
Identify and resolve operational or compliance issues related to medication management.
Support study start-up activities, including review of pharmacy manuals, budgeting for investigational product management, and readiness assessments.
Monitor performance and workflow efficiency to ensure timely and accurate medication services.
Maintain accurate , complete, and timely pharmacy documentation for all research studies.
Participate in protocol reviews, feasibility assessments, and study closeout procedures.
Prepare and provide reports on investigational drug inventory, usage, and compliance for regulatory and sponsor review .
Record study related activities in compliance with federal research rules and regulations and ALH standards- including but not limited to source and EDC.
Supervision of Research Pharmacy Technicians / Lead Pharmacy Technicians within the covered region (typically 1 to 5 employees).
Cross coverage/management of other regions during colleagues' absence/PTO.
Timely evaluations of performance for direct reports.
Provide coaching, training, and guidance for direct reports as well as other clinical research staff members as needed.
Ensure productivity measures and key performance indicators are developed, assigned, and are implemented and met.