Job ID :
US - Maryland - Rockville
- Reviewing of Certificate of Analysis and stability reports of all study products
- Study the current inventory management system and Internet ordering system and work with IT department to develop a new platform
- Review all temperature excursions and contact manufacturers to obtain stability information and send notifications to clinical research sites regarding suitability of products.
- Evaluate protocols for drug supplies in clinical research protocols and coordinate the acquisition of clinical supplies from manufacturers/suppliers.
- Provide drug forecast to manufactures to meet the supply needs of ongoing protocols.
- Negotiate and establish subcontractor support, when needed.
- Process pharmacy plan approvals received from Division of AIDS (DAIDS)
- Maintain the entire database of clinical research sites
- Enter data into the CPIMS system and forward the data to Clinical Site Information Office to be entered in DAIDS enterprise system
- Review site visit reports including but not limited to Auditing and Monitoring reports.
- Review and help resolve issues for CRS Pharmacy Establishment Plan (PEP) for approval.
- Correspond with DAIDS to discuss and resolve any site issues.
- Prepare tables and charts to aid Pharmaceutical Affairs Branch (PAB) in tracking site compliance issues.
- Develop a variety of forms such as a PEP Approval Check List, Approval Notification Letters, etc for review and tracking purposes.
- Assist PAB in resolving issues by providing insight and advice.
- Meet in person at PAB request when required.
- Write new and update current SOPs
- MS degree in pharmacy/science field, preferably Ph.D in chemistry. Two years’ experience in the field of pharmacy or health care administration related duties. Hospital pharmacy experience is a plus.
- Excellent computer skills using Microsoft Word, Excel and Power Point; and
- Good English oral and written communication skills
- Ability to develop a working relationship with a wide variety of people.
- Capable of resolving issues without promoting conflict.
- Strong spreadsheet skills so that information can be retrieved and reported readily.