Alysha Zipeto

Maintained working knowledge of and ensured compliance with applicable ICH-GCP Guidelines, local study specific regulatory requirements, SOPs, and study specific procedures

Experience in study start up, including, regulatory documents and submissions

Maintained compliance with required study specific trainings

Performed all tasks relevant to study participant selection and recruitment, screening, enrollment, and study specific activities (ordering and accountability of study investigational product, preparing and shipping labs, vital signs)

Active participator and contributor in instigator, sponsor, and coordinator meetings

Maintenance of study regulatory documents, including study start up, screening and enrollment logs, dug accountability logs, site signature logs

Completion of case report forms (CRFs)

Experience in dermatology, specifically Psoriasis, Vitiligo, Atopic Dermatitis (AD), Lupus, Alopecia Areata, Bullous Pemphigoid

Dispense outpatient investigational prescriptions utilizing outpatient computer program; Deliver patient-specific investigational medications to inpatient units if necessary

Receive investigational drug supplies and investigational products; verify counts and add to inventory; file all appropriate documents in study binder

Maintain investigational drug inventory by performing a physical inventory on each clinical trial monthly or as often as required and/or needed per individual investigational studies; resolve discrepancies as needed; monitor expiry dates and maintain separate inventory of expired or returned investigational drugs or empty vials; created spreadsheets of all investigational products and expiry dates to ensure proper quarantine, returns, and destruction if allowed

Perform compounding and handling of hazardous and chemotherapy investigational drugs using standards and hazardous/chemotherapy precautions in the Sterile Products area of the central pharmacy under supervision of pharmacist

Monitor and document refrigerator, freezer, and room temperatures daily in logs retained in a binder located in the Investigational Drug area

Assist investigational monitors during site visits by copying temperature logs or study materials when requested, escorting them throughout their visit to the Investigational Drug area, and pulling drug and/or expired/returned drug from shelf or refrigerator for monitor review during their visit

Organize and participate in site visits with the study sponsor to review completeness and accuracy of study documentation

Maintain patient confidentiality per HIPAA regulations; keep investigational products and study files in a safe and secure location; adhere to FDA Good Clinical Practice Guidelines; comply with all institutional policies and government regulations pertaining to human subjects protections

Knowledgeable in all aspects of compounding including radiopharmaceutical compounding

Knowledgeable in procedures, rules, laws relating to nuclear pharmacy

Able to receive, document, store incoming and outgoing radiopharmaceuticals according to Department of Transportation guidelines

Prepare prescriptions by taking and inputting customers’ orders under supervision of pharmacist

Able to compound and dispense radiopharmaceuticals under supervision of pharmacist, dispensing doses in syringes or vials where appropriate

Able to perform quality assurance tests on instruments and pharmaceuticals according to company standards

Prepare and maintain compliance documentation for preparing and shipping of radiopharmaceuticals

Able to select, prepare, and stock medications and supplies as well as maintaining computer inventory records

Over 16 years of pharmacy technician experience in a retail setting

Detail and results oriented; excellent time management skills and ability to prioritize

Knowledgeable in all aspects of prescription order processing

Understanding of the day to day pharmacy operations, roll-out initiatives, and company policies and procedures

Able to maintain inventory levels at critical times throughout the year; inventory specialist certified; involved in weekly and daily ordering of products; knowledgeable in inventory documentation

Knowledgeable in automated counting technology; Baker and ScriptPro automated counting machines

Facilitated scheduling of technician staff in a 20 employee pharmacy; worked with technician trainers to increase quality of staff

Supervised and developed a staff of 20 involving training, workflow, communication, conflict resolution and problem solving

Knowledgeable in all aspects of pharmacy documents including inventory and DEA records

Knowledgeable in all aspects of prescription accuracy, package standards, and productivity and inventory targets

Roll Out Support Trainer for RxConncet Application 2009 to 2010