Pharm Tech (Clinical Research)

The Pharmacist Technician will be an integral member of the clinical site team in supporting the operation on the different studies. Responsible for overall research pharmacy conduct in clinical research protocol implementation, including but not limited to protocol review, maintenance of inventory, procurement of investigational drugs and supplies, drug dispensing and documentation.  Also responsible for performing roles of a safety officer for the site.

KEY RESPONSIBILITIES

• Providing accurate and efficient dispensing of medication;
• Performing administrative responsibilities and maintain overall responsibility for pharmacy operations in assigned area.
• Accurately dispenses medications and prepares sterile products, following proper aseptic and cytotoxic technique.
• Reviews protocols of clinical investigational drug trials, as required.
• Liaises with principal investigators and/or trial coordinators/research assistants to implement dispensing, compounding and billing procedures.
• Maintains records to meet sponsor requirements, FDA regulations and legal requirements for pharmacy operations.
• Maintains and coordinates the distribution of an up-to-date clinical investigational drug trials list, as scheduled.
• Ensures the accuracy and integrity of products prior to their delivery to trial subjects.
• Ensure that medications are dispensed only upon written order of an investigator and according to standard operating procedures and study protocols.
• Maintains responsibility for the management of the inventory for clinical investigational drug trials orders, replaces and returns study materials, as required
• Monitors pharmacy activities on a daily basis to ensure adherence to study protocols and dispensing procedures
• Include IP  destruction and/or return shipment processes
• Manage the sponsor notifications, inventory and transfer of IP in the event of IP transfer or site relocation
• Work with Regulatory and Site director for the proper management of DEA 222 forms for handling of Schedule 1 products
• Communicate with sponsor and/or CRO representatives as needed. Be present and available for routine monitoring visits and close out visits.
• Maintain calibration records of site equipment
• Assist in Data entry for clinical trials.
• May require other duties and responsibilities as necessary.

PREFERRED SKILLS AND EDUCATION

• Master’s degree or equivalent Doctor of Pharnacy.
• At least 2 years of experience in a clinicalmedical environment. particularly within the clinical research industries.
• Work individually but as part of a team.
• High sense of urgency of procedures and operation
• Excellent communication skills and collaborative work ethic to support team efforts.
• Excellent attention to details and high accuracy level.
• Must have sound knowledge of medical terminology.