What are the responsibilities and job description for the PRN - Clinical Trial PharmD position at Lumi Research?
PRN - Clinical Trial PharmD
Company: Lumi Research
Location: Greater Houston Area
Employment Type: PRN
Salary Range: Based upon experience
Summary
The primary purpose of the Clinical Trial PharmD is to provide oversight for investigational drug services across ongoing and upcoming clinical trials. This role is responsible for ensuring the safe handling, storage, dispensing, and documentation of investigational products in compliance with study protocols, sponsor requirements, and regulatory standards. This is a flexible, as-needed position ideal for an experienced pharmacist with a background in clinical research, oncology, or infusion services.
**May travel to satellite sites if needed for drug delivery in the Greater Houston area.
Requirements:
- Proficient in pharmacy practice
- Able to work independently using past knowledge acquired through experience
- Think critically and quickly to resolve any logistical problems
- Able to work in an organized manner and follow up with pending items
- Able to multitask and use resources efficiently
- Able to work in a team environment
- Able to work in a startup capacity that can involve exposure to uncertain situations, context and priority changes
Qualifications:
- Oversee investigational product (IP) management, including receipt, storage, temperature monitoring, labeling, dispensing, and returns/destruction
- Ensure compliance with study protocols, good clinical practice (GCP), and applicable regulatory standards
- Maintain accurate and complete drug accountability logs and documentation
- Create and maintain pharmacy related SOPs
- Review and verify study prescriptions and dosing instructions for protocol adherence
- Collaborate with investigators, clinical research coordinators, sponsors, and CROs to support study execution
- Create patient-friendly handouts if needed/requested to ensure strict drug compliance
- Assist with site initiation visits (SIVs), monitoring visits, and audits/inspections.
- Provide guidance on pharmacy-related protocol requirements and investigational drug handling
- Support staff training in investigational product procedures and workflows
- Provides drug information to physicians, nurses, and other health care professionals, as related to clinical investigational trial drug
- Manage and document temperature excursions and protocol deviations
- Help ensure ongoing pharmacy readiness for sponsor and regulatory audits
- Business Development
- Creates new inventory system to maximize revenue
- Builds new inventory plan according to pipeline of trials
- Plans all treatments for every patient on a clinical trial, ensures drug availability
- Complies with all legal requirements and company policies
- Performs all other duties assigned
Experience: 8 years total; 5 years of pharmacy technician and 3 years in oncology practice