JOB TITLE- Research Pharmacist   
             

GENERAL SUMMARY OF DUTIES- Oversee investigational pharmacy operations and pharmacy technical staff  to support our institution’s growing involvement in clinical research activities. This service will provide support to industry-sponsored and investigator-initiated trials for multiple research sites in the outpatient setting. The investigational drug research pharmacist will interact with investigators, study sponsors, research personnel and other healthcare providers.

 
DUTIES INCLUDE BUT ARE NOT LIMITED TO:

Administrative

* Create, monitor, document, and follow departmental SOPs, corporate guidelines and conventions providing quality and accurate investigational pharmacy services.

* Develop, monitor and maintain step-by-step procedures (e.g., kits) for preparation, dispensing and distribution of investigational and study drugs. Develop codes, labels and other predefined formats for pharmacy computer entry.

* Assist as needed in preparing reports for company management and regulatory agencies.

* Participate in educational activities and programs.

* Maintain strictest confidentiality.

* Practice and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement.”

Operational

* Evaluate study protocols to determine appropriate resources and materials needed to satisfy study requirements.

* Retrieve and interpret medication orders; perform complex procedures and pharmaceutical calculations, taking into account research protocol, patient and drug characteristics.

* Perform specialized and advanced procedures specific to assigned pharmacy area; label, fill and provide delivery oversight of investigational drugs to appropriate patient care locations.

* Responsible for establishing and continually improving the shipment and delivery of investigational pharmaceutical care to patients within areas of direct responsibility and assisting others in the department with the same.

* Receipt and ongoing review of study protocols to determine appropriate pharmaceutical materials and professional services required to satisfy the study description.

* Establish and maintain accurate and easily retrievable recordkeeping systems for protocols, study subjects, tracking logs, schedules, drug accountability records, and systems. 

* Retrieve discontinued or expired medications from stock and research sites; discard or return to stock as appropriate; complete corresponding documentation. Serve as a primary training resource for technicians and evaluate their progress as directed; preparing schedules, setting work priorities and making work assignments as directed.

* Perform related work as required.

Communication

* Maintain liaison relationships by educating, directing and supporting trial projects with medical and nursing staff, sponsors and site personnel; provide timely information pertaining to investigational and pharmaceutical supplies, drug usage and compatibility, and state and federal regulations regarding drug controls. If applicable, respond to and/or review and direct completion of inquiries from internal customers, sponsors and pharmaceutical funding partners.

* Ensure site staff, Study Chairs, and members of the Consortium department understand the investigational drug maintenance, dispense and distribution process.
* Meet with investigators, study monitors, and others in coordinating study logistics; participate in staff meetings, site initiation and other meetings which will impact the delivery of quality research and compliance. 
* Receive and triage information requests; research and provide information where appropriate.
* Collaborate with Study Chairs and relevant staff to provide investigational drug trending and status reporting as needed for assigned clinical trials.
* Maintain positive and cooperative relationship in day-to-day interactions and communications.

Managerial/Oversight

* Display leadership ability, accepts responsibility, exercises authority and functions independently, uses effective written and verbal communication.

* Manage performance and development of Pharmacy staff members, budget and goals.

* Demonstrate ability to obtain and analyze facts and apply sound judgment.

* Remain cognizant of cost containment measures and create an atmosphere encouraging others in this practice.

* Oversee the activities of assigned pharmacy technicians engaged in the preparation, labeling and delivery of investigational drugs and other pharmaceutical supplies in accordance with physicians' orders; ensure accuracy and compliance with federal, state and local laws and regulations pertaining to the dispensing of drugs and the maintenance of required records.

* Communicate and escalate unresolved issues at the appropriate time and to the appropriate level of management.

* Provide proactive and creative recommendations on how to meet goals and handle identified deviations.

KNOWLEDGE, SKILLS & ABILITIES

* Must hold a degree from an accredited College of Pharmacy.

* Must be able to read, understand, and comply with research protocols.

* Must be able to perform duties commensurate with dispensing medications with narrow therapeutic indices.

* Proven knowledge of FDA guidelines and GCP is required.

* Excellent professional writing and communication skills.

* Excellent organizational and prioritizing capabilities.

* Resourceful with heightened analytical abilities and problem solving skills in a fast paced environment.

* Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, MS Access or Excel.

* Excellent interpersonal skills, detailed-oriented and meticulous.

EDUCATION

DPh required

PharmD preferred

EXPERIENCE

2+ years Chemotherapy Admixture

CERTIFICATION/LICENSE

Licensed Pharmacist