| Qualifications |
Pharm.D. degree or equivalent. Completion of Good Clinical Practice (GCP) training within the past 2 years.
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| Experience |
At least 3 years experience in clinical research pharmacy, preferably one supporting an early-phase, proof-of-concept operation. Experience in a good manufacturing practice (GMP), drug development in pharma or in project management with a CRO would also be beneficial.
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| Prerequisite Skills |
- Leadership qualities
- Works well in a team
- Scientific and research aptitude
- Education and training aptitude
- Quality management aptitude
- Has regulatory knowledge
- Fluent in English
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| Other activities |
In addition to the above-mentioned responsibilities, the Research Pharmacist is expected to: Initiate and participate in clinical research and other educational and training activities at MDRI. Initiate and participate in quality and process improvement activities at MDRI. Author/Train/Revise and maintain SOP’s as required
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| Reporting Structure |
The Research Pharmacist reports to MDRI Director of Operations. The Research Pharmacist also has a ‘dotted-line’ reporting to the Project Leader for study-specific matters.
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| Responsibilities |
- Ensure storage, dispensing, shipment, documentation, accountability, and/or destruction when applicable, of investigational products are performed in accordance with MDRI SOPs, industry standards and sponsor instructions
- Ensure proper supplies, storage, accountability, and security of emergency and rescue medications
- Maintain competency in aseptic technique which includes operating laminar hoods and reconstituting investigational products according to study protocols
- Ensure security of investigational products and controlled substances at all times not under direct visual control or manual handling
- Ensure proper storage of all investigation and non-investigational products
- Maintain inventories of all investigational and non-investigational products
- Work closely with study Project Leader and study team to ensure feasibility of protocols accepted at MDRI
- Work closely with study Project Leader and study team to assure timely supply, reconstitution, dispensing, and administration of investigational and non-investigational products, and collection of any unused products as directed by sponsor or protocol
- Ensure study personnel is adequately informed about proper administration of investigational and non-investigational products
- Maintain pharmacy SOPs
- Ensure adequate maintenance of all pharmacy equipment including backups and alarm systems
- Ensure compliance with all regulatory requirements
- Define investigational agent needs during protocol design consultations
- Coordinate multi-site efforts with Duke and Singapore research pharmacies
- Liaise with hospital pharmacy for required services as needed to maintain an integrated research pharmacy services model
- Develop and provide investigational drug product training materials to ensure proper handling, administration, documentation and disposal of investigational agents
- Assist in the notification, tracking and documentation of all pharmacy personnel work effort and deliverables for awarded projects
- Maximize efficiency of services through the use of automation and software tools
- Attend regular MDRI operational meetings
- Collaborate with research pharmacists of other Duke Proof-of-Concept (POC) units to ensure coordination and adequacy of protocol execution across the network – for multi-site protocols
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