Provide essential investigational drug services to Investigators and Research Personnel with responsibilities, critical and central to the conduct of the clinical investigation according to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements. Knowledge of the Health Insurance Portability and Accountability Act (HIPAA) and the ability to manage Protected Health Information (PHI).
- Monitor all aspects of investigational product (IP) while it is onsite. This includes accountability, ordering, receipt, storage, monitoring storage environment, security, preparation, inventory, and disposal.
- Perform and maintain all required documentation of investigational drug use.
- Monitor all aspects of investigational product. Pharmacist is responsible for storing IP and maintaining the blind.
- Interact with the COVID study sponsor and regulatory agencies.
- Attend various COVID study specific trainings throughout a study is required as are interaction during periodic visits from other entities.
- Bachelor’s degree in Pharmacy or Pharm.D. degree from an accredited school of Pharmacy.
- Current licensure from the Texas State Board of Pharmacy.
- Compounding experience
- Bilingual-English and Spanish
- Clean room (USP 797) experience
- Research experience
- Immunization Delivery/administration certification
- Intravenous (IV) certification/sterile products certification
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.