lydia Bahig Shawky

Regulatory and clinical research associateFull Time

• Job Details:Clinical operation services: 1- preparing documents, Regulatory procedures and submissions to local EC, RHD of MOH, NODCAR, NORCB, and Importation License for trials including ((Phase II, Idiopathic pulmonary fibrosis), (Multicenter Phase III, RDS), (Multicenter Phase IV, Hepatology), (Phase IV, Hepatology in one center), (Multicenter Phase III, Covid 19 vaccine) 2- Close out process for case report study (Phase IV) in one site 3- Assist in monitoring for prospective trial (phase II, oncology) in NCI 4- Also, I have experience as medical writer a. Medical writing for CSR b. Medical writing for advisory board meetings concerning oncology, Rheumatology, and ophthalmology c. Medical writing for the protocol of many studies concerning Hepatology, Pelvi-abdominal infections, Different Diabetes Management Regimens During Ramadan, and Treatment of Superficial wounds d. Medical writing and assist in publication for many papers concerning Urology, Diabetic Polyneuropathy, and HCV e. Designing CRF for many studies

TranscriptionFreelance / Project

• Job Details:Transcription for 2 focus groups and 15 in-depth interviews; concerning with patients experienced with addiction

Senior PharmacistFull Time