Per Diem Research Pharmacist (Investigational Drug Service)
2 days ago
Fresno
PER DIEM RESEARCH PHARMACIST (INVESTIGATIONAL DRUG SERVICE) Bakersfield, CA - Per Diem ABOUT FOLIO CLINICAL RESEARCH Folio Clinical Research is a leading urologic research network treating urologic cancers, urinary stones, Peyronie's disease, sexual and erectile dysfunction (ED), low testosterone, prostate disorders, urinary incontinence, and more. We partner with leading physician practices to create a cohesive, quality-oriented clinical culture, facilitating best practice sharing across our platform. Our affiliated practices gain access to a broad suite of clinical trials, providing significant benefits to both physicians and patients. ABOUT THE ROLE Folio Clinical Research is hiring a Per Diem Research Pharmacist to serve as the investigational drug service (IDS) lead at our partner clinic in Bakersfield, California. This role is established to support a metastatic prostate cancer clinical trial and other oncology and urology studies that require on-site sterile compounding of investigational products, conventional chemotherapy, and supportive care medications. Working in close partnership with the Principal Investigator, Sub-Investigators (including our Research Nurse Practitioner), and Clinical Research Coordinators, you will own medication order verification, compounding, dispensing, and accountability for all investigational and study-related products. The clinic is equipped with a clean room, and you will operate within that environment to prepare and dispense protocol-required medications in compliance with FDA, ICH-GCP, and California Board of Pharmacy requirements. This role is a strong fit for an experienced oncology or research pharmacist who is comfortable owning the IDS function for assigned protocols, working independently in a per diem capacity, and partnering effectively across a small, fast-paced clinical research team. If you are energized by clean documentation, audit readiness, and being the pharmacy backbone of a growing research program — this role is for you. RESPONSIBILITIES • Serve as the primary pharmacist of record for the investigational drug service at the partner clinic, supporting assigned protocols from site qualification through study close-out., • Review new protocols, amendments, and pharmacy manuals; develop study-specific dispensing procedures, dose preparation worksheets, and pharmacy source documents., • Manage investigational product receipt, storage, temperature monitoring, accountability logs, reconciliation, and return or destruction in accordance with sponsor and regulatory requirements., • Prepare, dispense, and verify investigational products, chemotherapy agents (including taxane-based regimens such as docetaxel and cabazitaxel), and supportive care medications., • Perform all sterile compounding within the on-site clean room in full compliance with USP and USP standards for sterile preparation and hazardous drug handling., • Verify medication orders for accuracy, including dose calculations (BSA-based and otherwise), patient eligibility against protocol criteria, drug interactions, and laboratory parameters., • Maintain blinding integrity where applicable; manage drug assignment and reconciliation through IRT/IXRS/RTSM systems., • Ensure compliance with ICH-GCP, FDA regulations (21 CFR Parts 11, 50, 56, 312), California Board of Pharmacy requirements, and sponsor protocols., • Support internal and external monitoring visits, sponsor audits, and inspections; respond to sponsor and CRO queries on pharmacy activities accurately and on time., • Provide drug information, dosing guidance, and protocol-specific clinical recommendations to investigators, CRCs, and partner clinic staff., • Support patient counseling and medication education for study participants as protocol-required., • Adhere to GCP, Good Documentation Standards, and ALCOA-C++ principles in all pharmacy records. QUALIFICATIONS • Doctor of Pharmacy (PharmD) from an ACPE-accredited School of Pharmacy., • Current, active, and unrestricted California Board of Pharmacy pharmacist license in good standing., • Minimum two years of hospital, clinic, infusion center, or oncology pharmacy practice experience., • Demonstrated proficiency in sterile compounding and hazardous drug handling under USP and USP, including hands-on experience compounding chemotherapy or other hazardous agents., • Working knowledge of ICH-GCP guidelines and FDA regulations (21 CFR Parts 11, 50, 56, 312) as they apply to investigational drug services., • Familiarity with investigational drug accountability, blinding/unblinding procedures, and sponsor monitoring expectations., • Strong attention to detail, documentation discipline, and ability to operate independently within established protocols., • Strong written and verbal communication skills; able to work effectively across investigators, research coordinators, sponsors, CROs, and partner clinic staff. PREFERRED QUALIFICATIONS • Board Certified Oncology Pharmacist (BCOP) certification., • PGY1 and/or PGY2 residency training in oncology, investigational drugs, or a related specialty., • Prior investigational drug service or research pharmacy experience at a clinical research site, SMO, cancer center, or academic medical center., • Hands-on experience with taxane-based chemotherapy regimens (e.g., docetaxel, cabazitaxel) and supportive care for advanced prostate cancer or other urologic oncology populations., • Familiarity with CTMS, EDC, IRT/IXRS/RTSM, and electronic pharmacy and accountability platforms; experience with CRIO a plus., • Experience supporting FDA inspections, sponsor audits, or qualification visits., • Completion of CITI Program training (Human Subjects Research and/or GCP modules). Position Summary Job Type: Per Diem Work Location: On-site at Folio Clinical Research's partner clinic in Bakersfield, CA. Candidates commuting from the greater Los Angeles area will be considered. Medical Specialty: Urology / Oncology Schedule: Variable per diem shifts coordinated around infusion days and protocol-required visit windows; typically during standard business hours. Education: PharmD (Required) Licensure: Active California Board of Pharmacy pharmacist license (Required) Experience: Hospital, clinic, infusion center, or oncology pharmacy: 2+ years (Required); investigational drug service or research pharmacy: Preferred; BCOP certification or PGY1/PGY2 residency: Preferred Any data provided as a part of this application will be stored in accordance with our Policy. Folio Clinical Research is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.