- Rockville, MD
What you'll be doing
- The CRPMC pharmacist/CRS acting in support of DAIDS reviews clinical research site (CRS) pharmacy monitoring reports to identify problems and assist resolution. Records and tracks the results of the review in a DAIDS data base and meets regularly with the DAIDS pharmacists to discuss outstanding issues. Reviews pharmacy establishment plans for CRS pharmacies to assess adequacy of compliance to standards established by DAIDS. Work with the CRS pharmacist to resolve problems in order to come into compliance when necessary. As necessary travel to CRS pharmacies for consultant visit or cause. Prepare and submit a report to the DAIDS with the results of this travel. As time permits, performs clinical research protocol pharmaceutical analysis, manages protocol study products to include the preparation of documents for international shipments. Develop and revise SOPs. Maintain all reference documents and files related to program requirements. The CRPMC pharmacist also provides support and investigational agent distribution for government clients NIAID/DAIDS, monitors the product/protocol/project from initiation through delivery, and interfaces with customer on all matters.
What your background should be
- Maryland pharmacy license with a minimum of three years experience in clinical research pharmacy or clinical trial materials management. Experience with clinical trials material management. Knowledge of federal, state and international regulation as apply to products, processes, practices, and procedures. Knowledge of regulatory affairs; analytical, research, written, editing, and verbal communication skills. Skills in medical discipline. Proficiency with Microsoft Office products. 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.
Required Schooling / Training
- Bachelor degree in pharmacy.
Who is the client company
- A multinational biotechnology product development leading company that providing analytical and laboratory products and services.
- If you are interested in this position, send your resume to firstname.lastname@example.org