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Nursel Demirkapi, Ph.D. is listed as Clinical Research Consultant at EnKaMed at EnKaMed, Montreal, QC, Canada, based in Greater Montreal Metropolitan Area, Canada, Canada. AeroLeads shows a matched LinkedIn profile for Nursel Demirkapi, Ph.D..
Nursel Demirkapi, Ph.D. previously worked as Clinical Research Consultant at Enkamed, Montreal, Qc, Canada and Senior Clinical Research Associate at Icon Clinical Research, Montreal, Qc, Canada. Nursel Demirkapi, Ph.D. holds Ph.D. from University Of Paris, France.
I have over 18 years of experience as a Clinical Research Associate (CRA), Lead CRA and Project Manager, working for Pharmaceuticals, Contract Research Organizations and Medical Device Company. Excellent communication skills in 4 languages (English, French, German, Turkish) and a pro-active vision of clinical research from feasibility to study archival, including project management and successful multi-million dollar contract negotiations.I have performed all types of monitoring visits including Pre-Study/Selection, Initiation, Interim and Close-Out visits. I am able to form strong, effective relationships with investigative sites in order to become their primary contact in the execution of the clinical trial.Specialties: Specialties:Exceptional and varied monitoring skills and experience; Full appreciation of the application of both the FDA/TPP's regulations and ICH guidelines; Experience with drug and medical device trials; Protocol and Informed Consent writing and editing; study document creation (source documents, SOPs and CRFs); Submission of Electronic Case Report Forms(EDC- InForm); Serious Advers Event( SAEs) reporting, Clinical grants, exceptional computer skills.
Listed skills include Clinical Monitoring, Clinical Research, Edc, Sop, and 8 others.
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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.
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.
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Nursel Demirkapi, Ph.D. works for EnKaMed, Montreal, QC, Canada.
Nursel Demirkapi, Ph.D. is listed as Clinical Research Consultant at EnKaMed at EnKaMed, Montreal, QC, Canada.
Nursel Demirkapi, Ph.D. is based in Greater Montreal Metropolitan Area, Canada, Canada while working with EnKaMed, Montreal, QC, Canada.
Nursel Demirkapi, Ph.D. has worked for Enkamed, Montreal, Qc, Canada, Icon Clinical Research, Montreal, Qc, Canada, Covance Canada, Montreal, Qc, Canada, Enka Clinical Trials Inc., Montreal, Qc, Canada, and Cryocath Technologies, Montreal, Qc, Canada.
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Nursel Demirkapi, Ph.D. holds Ph.D. from University Of Paris, France.
Nursel Demirkapi, Ph.D. is listed with skills including Clinical Monitoring, Clinical Research, Edc, Sop, Protocol, Rheumatoid Arthritis, Clinical Trials, and Ich Gcp.
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