Nursel Demirkapi, Ph.D. Email & Phone Number

Performs and co-ordinates assigned aspects of clinical monitoring process in accordance with ICH/GCP guidelines and sponsor's specific SOP's to assess the safety and efficacy of investigational products.Therapeutic ExperienceCardiology: Heart Failure, Atherosclerosis, Acute Myocardial Infarction, Hypertension, Angina Pectoris, Atrial embolism/thrombosis, Arrhythmia (device)Oncology: Multiple Myeloma, Solid tumors, Lymphoid Leukemia, Myeloid Leukemia, Relapse &Refractory… Show more Performs and co-ordinates assigned aspects of clinical monitoring process in accordance with ICH/GCP guidelines and sponsor's specific SOP's to assess the safety and efficacy of investigational products.Therapeutic ExperienceCardiology: Heart Failure, Atherosclerosis, Acute Myocardial Infarction, Hypertension, Angina Pectoris, Atrial embolism/thrombosis, Arrhythmia (device)Oncology: Multiple Myeloma, Solid tumors, Lymphoid Leukemia, Myeloid Leukemia, Relapse &Refractory Lymphoma, Lung and Prostate cancerRheumatology: Rheumatoid Arthritis, Osteoporosis, Osteoarthritis, and Psoriatic ArthritisEndocrinology: Diabetes Mellitus Type IINeurology: Alzheimer’s disease, Multiple SclerosisHematology: Coagulation defects/ITPRespiratory: Asthma, Allergic Rhinitis, and Pneumonia Immunology: Kidney transplantDermatology: Psoriasis, Dermatitis Show less

Managed the clinical trial process from study start up to final close-out for the assigned projects/sites. Implemented all aspects of clinical trials including managing and monitoring investigative study sites.

Experienced in managing multiple sites and multiple protocols. Implementing of all aspects of clinical trials including managing and monitoring investigative study sites. Lead /Supervise CRAs for Phase III Oncology study. Plan, track and overall study budget and timelines.

Responsible for managing the clinical trial process to ensure compliance with regulatory issues, protocol requirements and Good Clinical Practices. Managing the process from study start up to final close-out for the assigned projects/sites.

Responsibilities included the organization, planning, timely execution, reporting and evaluation of the clinical program objectives. Manages clinical projects to schedules and budgets. Manages and directs CRO selection and activities.

Home- based CRA with a contract research organization. Experienced in managing multiple sites and multiple protocols. Implementing of all aspects of clinical trials including managing and monitoring( phase II and III) investigative study sites in Canada and US.

Coordinating all aspects of pharmaceutical studies, including managing and monitoring investigative study sites of phase III clinical trials in Canada. Supervise CRAs and external vendors to ensure all study activities are completed in accordance with applicable regulations, FDA, TPP, ICH/GCPs and SOPs.

Ph.D.

Master Degree In Biochemistry

Pharmacy Degree