Fisher BioServices, Clinical Research Products Management Center (CRPMC) pharmacist provides support and investigational agent distribution for government clients, NIAID/DAIDS. Monitors the product/protocol/project from initiation through delivery, interfacing with customer on all matters (NIAID/DAIDS). Duties include reviewing and approving clinical site orders, reviewing clinical research protocols and calculating supply requirements, managing supply levels and expiration date of products, interacting with pharmaceutical manufactures, communicating with clinical site pharmacists, conduct clinical site audits/visits, international shipping of investigational drugs, and involvement with packaging and labeling investigational agents.
A qualified candidate must be a registered pharmacist in Maryland with good communication skills, willing to travel with short notice, and working knowledge of Microsoft Office programs. Experience in the pharmaceutical industry, clinical research, or hospital pharmacy is desirable. A working knowledge of the Good Manufacturing Practices, import/export of pharmaceuticals, and Spanish speaking are plus.
Essential Duties and Responsibilities:
- Establishing drug requirements for new protocols.
- Creating drug supply statements for new protocol.
- Review protocol revisions for impact on inventory levels and update existing drug supply statements.
- Maintain files and all reference documents related to program protocols
- Process product Certificates of Analysis (CoAs) and submit to the PAB QC Committee, NIAID/DAIDS, for product review.
- Design and create drug labels.
- Oversee CRPMC repackaging and labeling programs.
- Develop packaging and labeling requirements to meet US, and International packaging and labeling standards.
- Create and maintain batch records.
- Serve the primary liaison to clinical site pharmacists.
- Supervise proper shipping and distribution of Investigational agents to clinical sites.
- Monitor quantity and expiration date of supplies being issued.
- Monitor temperature for temperature sensitive products, and international shipments during transit.
- Prepare documents for international shipments and arrange international shipment pickups.
- Develop and revise Standard Operating Procedures (SOPs).
- Review pharmacy audits, notify project Officer of clinical site problems, and maintain database containing a summary of all pharmacy audits.
- Manage CRPMC daily operations.
- Assist Project Director (PD) and function as PD in his/her absence.
- Applies Good Manufacturing Principles in all areas of responsibility.
- Process customer complains.
- Initiate and authorize product recalls.
- Manage DAIDS Authorized Witness (DAW) program.
- Intermediate computer skills (data entry, word processing, spreadsheets); and
- Good communication skills to include English (written and oral).
- Experience with clinical trials material management.
- Knowledge of Import/Export requirements for clinical study products.
- Knowledge of federal, state, and /or international regulation as they apply to products, processes practices, and procedures.
- Possess a BS degree in Pharmacy with at least five years’ experience in the pharmaceutical field and be a registered pharmacist in Maryland;
Certificates and/ or Licenses:
- Maryland Pharmacy Practice License
- Supervisory ability is desirable
Ability and/or Skills:
Knowledge of regulatory affairs; analytical, research, written, editing , and verbal communication skills; Skills in medical discipline; Proficiency with computer word processing, label works; Proficiency using Internet tools to obtain technical reports from Government and other Web sites; Skilled in working and communicating with staff, and project personnel on technical issues, Strong organizational skills, detail oriented, and ability to work with multiple projects; Skilled in working without supervision.
- Must be able to use a computer for up to eight hours per day.
- Must be able to type/word process for up to four hours per day.
- Full time, 8AM-5PM 5 days /week.
- Provide PAB with support on clinical site audits/visits;
- Research regulatory and cultural requirements for drug storage and distribution at international sites;
- Contribute to the monthly Progress Report;
- Provide cGMP training to CRPMC staff;
- Assist in hiring and managing CRPMC personnel;
- Participate in emergency and weekend on-call for the CRPMC; and
- Perform special projects, as assigned, by the PD and/or contract Project Contracting Officer Technical Representative;
- Help oversee and supervise the ICRPMC operations. Conduct ICRPMC site visits when necessary
- Advanced current Good Manufacturing Practices;
- CPIMS database; and
- Specific Knowledge concerning function SOPs, and general knowledge concerning Clinical and Biological Services manuals listed below:
- CRPMC SOPs
- Employee Handbook
- Corporate Policies and procedures Manual
- Facility Safety Plan
- Facility Operations Manual
- Quality Assurance Manual