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.
Specific Requirements and Preferences
Completion of a five year pharmacy program in an accredited college of pharmacy. .
Minimum Work Experience
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. .
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.
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.
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.
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.
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.
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.
Organizational Accountabilities (Staff)
Organizational Commitment/Identification 1. Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication 1. Demonstrate collaborative and respectful behavior
2. Partner with all team members to achieve goals
3. Receptive to others’ ideas and opinions
Performance Improvement/Problem-solving 1. Contribute to a positive work environment
2. Demonstrate flexibility and willingness to change
3. Identify opportunities to improve clinical and administrative processes
4. Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility 1. Use resources efficiently
2. Search for less costly ways of doing things
Safety 1. Speak up when team members appear to exhibit unsafe behavior or performance
2. Continuously validate and verify information needed for decision making or documentation
3. Stop in the face of uncertainty and takes time to resolve the situation
4. Demonstrate accurate, clear and timely verbal and written communication
5. Actively promote safety for patients, families, visitors and co-workers
6. Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance