System Manager, Investigational Drug Pharmacy

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.