Job Description

The Behavioral Pharmacology Research Unit (BPRU) is seeking a highly qualified Pharmacist to provide specialized pharmaceutical oversight and support for research studies. The successful candidate will perform comprehensive reviews and analyses of all aspects of investigational drug management, including product sourcing, handling, preparation, labeling, storage, and study design, to ensure regulatory compliance and the successful execution of research protocols.

Specific Duties and Responsibilities

• Will perform and oversee all pharmacy technical functions including,
• Preparation and development of pharmacy protocols for all medications prepared.
• Preparation, distribution, and accountability of drugs utilized in human experimental research; as well as recording, receiving, and storing all pharmaceutical supplies.
• Determining bulk compounds needed. Oversee packaging and labeling of all products compounded.
• Compounding (including bulk compounding) and calculating the correct amount of all drugs.
• Calculating and converting to proper weights and measures the amount of solution and drugs to be used, taking into account concentration, overfill for slight losses during mixture, and number of doses contained in the solution.
• Carrying out and overseeing all quality assurance activities to insure the safe and accurate preparation of treatment and research medications.
• Prepares all clinical research drugs and commercial medications based on written requirements for the Behavioral Pharmacology Research Unit (BPRU) and the Clinical Research Unit (CRU).
• Compiles drug information and maintains appropriate references.
• Assists Pharmacy Research Assistant in recognizing atypical occurrences when compounding, e.g. changes in color, consistency, etc.
• Operates all equipment safely, effectively and in compliance with manufacturer’s recommendations.
• Oversees Pharmacy Research Assistant in areas above.
• Other duties as job dictates.

Responsible for maintaining security of all drugs stored in the pharmacy.

• Oversees pharmacy research assistant in all areas above.
• Other duties as job dictates.

Coordinates Quality Assurance/Control activities for the pharmacy.

• Oversees and directs collection and interpretation of Quality Assurance/Control activities.
• Oversees Pharmacy Research Assistant in areas above.
• Other duties as job dictates.

Completes all required documentation and presents documentation according to established guidelines and time frames.

• Completes all record-keeping requirements for medications as required by federal, state, and local laws.
• Maintains and ensures all documentation required for the Joint Commission is complete.
• Monitors and documents work hours for Pharmacy Research Assistants.
• Oversees ordering of all supplies for the pharmacy and documentation of such.
• Maintains licensing and certification when required.
• Maintain and ensure DEA required inventories of all controlled drugs.
• Oversees and coordinates destruction of all expired/unusable scheduled and non-scheduled drugs in accordance with, state, and federal regulations.
• Develop pharmacy policy/procedure for all investigational drug preparation while maintaining blind drug status, stability, and FDA requirements.
• Oversees Pharmacy Research Assistant in areas above.
• Other duties as job dictates

Will adhere to safety procedures.

• Assures strict adherence to aseptic techniques for use of the glove box and all other special equipment.
• Monitors medications to determine that substances are delivered to the proper person in a safe and appropriate manner (adheres to the 5 R’s: for the Right Patient, Right Dose, Right Dosage Form, Right Time, Right Medication).
• Attends training as required for safety.
• Oversees Pharmacy Research Assistant in areas above.
• Other duties as job dictates.

Will know, understand, and abide by the Johns Hopkins University, BPRU policies and procedures, protocol specific procedures in accordance with the IRB.

• Responsible for annual and as needed revision of BPRU pharmacy policies.
• Will ensure Pharmacy Research Assistants know, understand, and abide by the Johns Hopkins University and BPRU policies and procedures.
• Will treat customers with courtesy, respect, and caring behaviors.
• Demonstrates good interpersonal skills with all customers.
• Responds quickly and appropriately to customer requests.
• Consistently demonstrates in-depth knowledge of departmental issues and practices in dealing with customer’s problems.
• Anticipates customer needs and initiates action to meet those needs.
• Coordinate and interface with representatives of regulatory agencies and pharmaceutical research sponsors as required.
• Collaborates with BPRU faculty and fellows on a broad range of clinical pharmacology studies and clinical trials.
• Oversees Pharmacy Research Assistant in areas above.
• Other duties as job dictates

Will identify areas of development and seek opportunities for personal and professional growth.

• Participates and contributes to the educational program of the BPRU’s post-doctoral fellowship training program.
• Will complete all mandatory educational requirements per Joint Commission, State Board of Pharmacy, BPRU, IRB, and JHU.
• Oversees Pharmacy Research Assistant in areas above.
• Other duties as job dictates.

Will work cooperatively within own department and with other departments/units.

• Demonstrates good interpersonal skills.
• Attends staff meetings on a regular basis.
• Provides timely feedback to the appropriate customer in a clear and concise manner.
• Communicates relevant research participant changes to appropriate staff without breaking the study blind.
• Oversees Pharmacy Research Assistant in areas above.
• Other duties as job dictates.

Ensures Pharmacy Research Assistant will use professional judgment in providing information based on specific situations and is sensitive to individual and organizational concerns.

• Will ensure Pharmacy Research Assistant consistently serve as a credible representative of the department.
• Will ensure Pharmacy Research Assistant follow appropriate channels and keep appropriate staff informed of relevant issues and events.
• Will ensure Pharmacy Research Assistant consistently maintain confidentiality.
• Adheres to federal confidentiality and HIPAA regulations.
• Oversees Pharmacy Research Assistant in areas above.
• Other duties as job dictates.

Will coordinate and oversee routine maintenance on equipment as indicated by manufacturer’s recommendations and policy.

• Oversees coordination of repair of faulty equipment.
• Oversees scheduling of routine preventive maintenance of equipment.
• Oversees Pharmacy Research Assistant in areas above.
• Other duties as job dictates.

Knowledge, Skills, and Abilities Required

• Pharmacist training from an accredited school with experience and understanding satisfactory to provide skills outlined above. Knowledge of research issues and concerns highly desired.
• Has a working knowledge of pharmacy law, Joint Commission, FDA, DEA, and relevant state requirements for control of scheduled substances.
• Knowledge of drug abuse, alcoholism, and related health care issues.
• Transport equipment and supplies usually less than 25 pounds.
• Experience with computers required. Experience with Macintosh or Windows preferred.
• Excellent organizational skills required.

Minimum Qualifications

• Must be licensed in the State of Maryland and must maintain licensure throughout duration of employment.
• Must be registered with the Maryland State Board of Pharmacy.
• Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Pharmacist training from an accredited school with experience and understanding satisfactory to provide skills outlined above.
• Knowledge of research issues concerns highly desired.

Classified Title: Pharmacist
Role/Level/Range: ACRP/04/MG
Starting Salary Range: $42.01 - $73.50 HRLY ($88,691.20 targeted; Commensurate w/exp.)
Employee group: Casual / On Call
Schedule: varies/19
FLSA Status: Exempt
Location: Johns Hopkins Bayview
Department name: SOM Psy Bay Behavioral Pharm Rserch Unit
Personnel area: School of Medicine