The Investigational Drug Pharmacist will be responsible to coordinate the use of investigational drugs that are handled and dispensed from the pharmacy. Will work in pharmacy operation for portion of time and has assigned office days to complete other tasks related to investigational drugs.
Project Management 1. Receive copies of investigational and study protocols. 2. Review documents and determine pharmaceutical materials and professional services required to satisfy the study description. 3. Develop step-by-step procedures (e.g., kits) for preparation, dispensing and distribution of investigational and study drugs; develop codes, labels and other pre-defined formats for pharmacy computer entry. 4. Provide randomization, blinding and other consultative activities to principal investigators. 5. Establish budget or fee schedule for studies and collect dispensing and handling fees as appropriate. 6. Meet with investigators, study monitors, and others to coordinate study logistics.
Training 1. Responsible for the development of staff training programs regarding investigational and study drug procedures. 2. Train professional and non-professional personnel in the preparation of these agents, labeling, appropriate record keeping and dispensing and kit utilization. 3. Prepare drug monographs for nursing as needed. 4. Prepare drug data sheets and other documents for pharmacy personnel.
Record Keeping 1. Assist to establish and maintain adequate and easily retrievable record keeping systems for protocols, study subjects, drug inventory, manufacturing, and dispensing investigational drugs. 2. Ensure that paperwork is completed and retained, and investigational and study drugs are handled according to the requirements of the sponsoring agencies. 3. Responsible for and assist with the development of statistical reports and activity summaries on a monthly basis.
Inventory Control 1. Establish and maintain standards which assure the quality, proper storage, and safe use of all investigational agents and related supplies. 2. Coordinate or delegate the ordering and stocking of investigational and study agents as needed to maintain adequate inventory levels. 3. Coordinate the removal and disposal of expired stock or stock from completed or terminated studies. 4. Ensure this work is done according to protocol guidelines or Departmental policy. 5. Responsible for and assist with monthly audits of inventory, dispensing records and files by investigators or study sponsors.
Preparations 1. Prepare special formulations of investigational agents under unusual circumstances as dictated by a particular protocol; maintain a neat and clean working area and develop a well organized work routine.
Specific Requirements and Preferences Completion of a five year pharmacy program in an accredited college of pharmacy. .
Minimum Work Experience 1 year
Specific Requirements and Preferences At least 1 year of pharmacy experience in a pediatric specialized or academic or clinical setting. Completion of a pharmacy residency program/advanced degree and/or significant work experience in a pharmacy. .
Required Skills/Knowledge Effective oral and written communication skills as well as interpersonal relations.
Required Licenses and Certifications Pharmacist Licensure or eligibility for licensure in the District of Columbia is required.
About Children's National Hospital
Children’s National Hospital has been serving the Washington metropolitan area for more than 100 years and ranks amongst the best pediatric hospitals in the country.
Children’s National Hospital- the area’s only comprehensive pediatric network- we offer all the care the family needs, from critical emergencies to primary care health.
-Children’s Hospital- over 300 licensed beds
-7 Regional Outpatient Centers
-Two Suburban Ambulatory Surgical Locations
-7 Community-Based Health Centers
-Hearing and Speech Center
-Community-Based Primary Care Pediatricians
The network provides comprehensive care from hospitalization to outpatient care in more than 40 subspecialties.
Children’s is located near the US Capitol, the American Society of Health-Systems Pharmacists, the National Institutes of Health, the Food and Drug Administration, and the National Library of Medicine.
The hospital serves as the regional referral center for pediatric emergency trauma care, as well as cancer, neonatology, and critical care.
Children’s is a leader in development of innovative new treatments for childhood illness and injury.
The Pharmacy employs clinical pharmacist...s who specialize and practice in the following areas:
-General Pediatric Medicine (7E)
-Bone Marrow Transplant (4E)
-Pediatric Intensive Care (3E)
-Neonatal Intensive Care (6E)
-Cardiac Intensive Care (3Main)
-Emergency Medicine (ground floor, East tower)
-Neurosciences/Surgical Care (5E)
-Investigational Drugs (3.5 Main)
-Solid Organ Transplant
The Division of Pharmacy Services provides twenty-four hour centralized and decentralized operations.
The department provides the following comprehensive services:
-Intravenous and parenteral nutrition admixtures
-Extensive product formulation and compounding
The Pharmacy utilizes the latest in technology to assist with dispensing.
-Medi-Dose®, makes standardized labels for unit dosing bulk medications
-ABACUS®, TPN physician order entry system that eliminates paper orders for TPNs
-Pyxis®, automated dispensing cabinets to assist with the inventory and storage of medications. These machines are located on every unit in the hospital as well as the OR and the regional outpatient centers.
-DoseEdge® is utilized to capture pictures of the preparation process of IVs and orals within our institution. This also helps us track where the products are throughout the system.
-Cerner®, computerized prescriber order entry with pharmacist order verification.