System Manager, Investigational Drug Pharmacy

2 weeks ago


La Grange, United States Baptist Health Full time
Job Description:

Baptist Health is looking for a System Manager, Investigational Drug Pharmacist to join our Pharmacy team at the Central Pharmacy, LaGrange, KY

  • Design, implement, and manage research projects related to medication systems and clinical pharmacy practices.
  • Evaluate, interpret and coordinate information relating to drug research studies for the System, including:
  • Committee and project participation
  • Human participant protection education.
  • Leads research protocol review and assessment.
  • Completion of Pharmacy assessment resource utilization for research studies.
  • Preparation of medication fact sheet for the research manual.
  • In-servicing of appropriate pharmacy and medical personnel.
  • Investigational drug build submissions and subsequent approval for use in electronic health record
  • Assist in protocol build validation in electronic health record
  • Participation in study feasibility discussions, preliminary site selection visits, site initiation visits, audits and closeouts.
  • Travel to start-up meetings when appropriate.
  • Assist local sites with enrollment, randomization, blinding, logging, preparation, dispensing, delivery, accounting and storage of investigational drugs.
  • Prepare and review documentation for Investigational New Drug (IND) applications and other regulatory submissions.
  • Serve as a system expert on research studies and clinical trials that the BH system is enrolled in.
  • Assist in the development of SOP and Policies relating to investigational/ research drugs.
  • Ensure compliance with FDA regulations, Good Clinical Practice (GCP), and institutional policies.
  • Conduct audits, site visits and inspections to ensure adherence to regulatory requirements and ensure accurate documentation and records of research activities and outcomes are maintained.
  • Participate in quality improvement initiatives and ensure the ethical use of investigational drugs and the protection of patient safety.
  • Assist with responding to any queries or audits by federal and state agencies with regards to clinical trials or investigational drugs.
  • Collaborate with system and local clinical research teams and IT teams to support trial design, drug protocol development and EMR build.
  • Provide education and training to pharmacy staff and other healthcare professionals on new systems, practices, and research findings.
  • Develop and disseminate educational materials related to medication management, investigational drug handling and compliance and research outcomes.
Minimum Requirements
  • Bachelor's degree in Pharmacy or PharmD required.
  • Master's degree preferred, board certification or other advanced certification preferred.
  • Kentucky and/or Indiana Board of Pharmacy license based on requirements of practice site or willing and eligible to achieve within 6 months of hire. Kentucky license must specify preceptor.
  • 5 years of job-related experience.
  • Valid driver's license required.
  • Must obtain CITI Good Clinical Practices (GCP) and Human Subjects Protection (HSP) training within 6 months
  • Completion of PGY-1/PGY-2 ASHP-accredited Pharmacy Residency in administration preferred or previous management experience preferred.


If you would like to be part of a growing family focused on supporting clinical excellence, teamwork and innovation, we urge you to apply now

Baptist Health is an Equal Employment Opportunity employer.

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