Alyssa Leidig Email & Phone Number

Primary tasks include direct handling of Investigational Product on site. Dispense IP while maintaining specific study blinding plans. Maintain documentation of all IP accountability including receipts, dispensing, return and/or destruction. Ensure all IP is stored and maintained at correct temperatures per protocol. Administer IP in accordance with protocol and pharmacy manual. Manage all inventory including removal of all expired products and reordering new supplies. On site and remote visits with Monitors, Sponsors, and Auditors. In charge of monitoring all temperature devices and reporting. Train new hires on site and study specific protocols and tasks. Maintain current updated training logs and IRT reports.

Conduct and manage clinical trials including phase 1-3 studies under the supervision of the primary investigator. Maintain accordance with protocols, provide accurate records, facilitate patient visits as well as all applicable testing including but not limited to blood draws and processing, vitals, ECGs, IV infusions, medical history review, and subcutaneous injections. Direct work with CRAs in both open label and double masked studies. Regulatory experience including but not limited to SOP’s, IRB’s, IB’s, IP dispensing, AE and SAE reporting. Clinical trial experience: Alzheimer’s, Age Related Macular Degeneration(Dry/Wet), Gene Therapy, Geographic Atrophy, Type 2 Diabetes/Diabetic Retinopathy, Device trials

Trained on working up patient visits including standard ophthalmic refracting exams, surgical exams both Lasik and cataract surgery, and patient emergency visits. Proficient in ancillary devices which include, but not limited to, OCT and Fundus photo imaging, administering Visual Field test, and Zeiss Angiogram imaging. Tasks also included applanation tonometry, vitals, and medical history review, and dilation.

Duties included working directly with the ENT department head surgeon of the children's department as his scribe. Creating patient charts (HPI), updating MD findings, history review, confirming scheduled and upcoming surgeries, and updating patient plan of action.

Duties included distribution of merchandise, answering phones, providing customer service, product pricing, cashier operations, and raising funds for the local animal shelter associated with the company.

Provided administrative support to the direct manager on site, tracked sales and inventory, created patient charts, prepared payroll, handled payment and transactions, scheduled and confirmed patient appointments.

Assisted manager with ordering and receiving product and shipments, stock showroom, provide customer care and support for all clients, as well as maintained records of all transactions.

English Literature (British And Commonwealth)

International/Global Studies