Cecilia Kayali's Email Addresses & Phone Numbers

I am a hard working individual and I aim to exceed expectations. I am ambitious to succeed in my professional careerClinical Research Coordinator II @ From May 2014 to Present (1 year 8 months) Associate Clinical Research Coordinator @ Responsible for conducting Clinical Trials under Good Clinical Practice: To communicate with Sponsors before the trial starts, during...

I am a hard working individual and I aim to exceed expectations. I am ambitious to succeed in my professional careerClinical Research Coordinator II @ From May 2014 to Present (1 year 8 months) Associate Clinical Research Coordinator @ Responsible for conducting Clinical Trials under Good Clinical Practice: To communicate with Sponsors before the trial starts, during the trial and after the trial ends to ensure all necessary study-related information is obtained. To review the specific trial’s Protocol before and after finalization. Responsible for preparing Case Report Forms and other study-related documentation for each specific clinical trial as per the Trial’s Protocol and Safety Information. In charge of writing the Informed Consent Form, Subject Instructions, Subject Daily Logs and/or other documents which will be viewed by participants of the specific Clinical Trials. To make sure all clinical trials are run under the Declaration of Helsinki. To ensure that the rights, safety and welfare of the trial’s participants overcome the objectives of the clinical trials. To report any Adverse Event that occurs during a clinical trial and to follow through until the Adverse Event is resolved. To inform and delegate the clinical staff of the procedures and any new changes in the specific clinical trials. Responsible for Product Receipt and Product Accountability before the trial starts, during the trial and after the trial ends. To review and to ensure the trial’s data report is accurate and reflects information attained from the clinical trial. From April 2012 to May 2014 (2 years 2 months) Assistant Clinical Research Coordinator @ Responsible for conducting Clinical Trials under Good Clinical Practice: To communicate with Sponsors before the trial starts, during the trial and after the trial ends to ensure all necessary study-related information is obtained. To review the specific trial’s Protocol before and after finalization. Responsible for preparing Case Report Forms and other study-related documentation for each specific clinical trial as per the Trial’s Protocol and Safety Information. In charge of writing the Informed Consent Form, Subject Instructions, Subject Daily Logs and/or other documents which will be viewed by participants of the specific Clinical Trials. To make sure all clinical trials are run under the Declaration of Helsinki. To ensure that the rights, safety and welfare of the trial’s participants overcome the objectives of the clinical trials. To report any Adverse Event that occurs during a clinical trial and to follow through until the Adverse Event is resolved. To inform and delegate the clinical staff of the procedures and any new changes in the specific clinical trials. Responsible for Product Receipt and Product Accountability before the trial starts, during the trial and after the trial ends. To review and to ensure the trial’s data report is accurate and reflects information attained from the clinical trial. From April 2012 to June 2012 (3 months) Clinical Regulatory Assistant @ To compile regulatory submissions to IRB's and provide regulatory expertise to the clinical department following FDA regulations Manage the movement of regulatory documentation interdepartmentally for review and approval Responsible for ensuring regulatory compliance to current and new regulations related to study conduct, protocol development, informed consent form creation, and dissemination of new information to my colleagues. To insure timely submission of complete, accurate and neat documents to the corresponding pharmaceutical sponsors and IRB IRB submission of all necessary documents Keep documents updated with signatures Creation of CRF's and other Source Documents Quality assurance and regulatory compliance of documents Tracking of new submissions of studies, approvals, amendments, start dates and end dates, and closeout dates of studies. Tracking of invoices from IRB's From February 2011 to April 2012 (1 year 3 months) Customer Service Associate @ Responsible for all tuxedo rental activities: Initial Consultation ­ Individual or Group product details Measurement and Entry of specifications into the database Coordination of shipment and pick-up of rentals Wardrobe selection assistance Customer Service and Dispute Resolution Inventory Management Set-up and dismantle of marketing and promotional media such as displays, special events, wardrobe selection assistance, etc. From January 2010 to February 2011 (1 year 2 months) Patient Recruitment Coordinator @ To administer recruitment activities of new and existing subjects and maintain the updated status of new and existing studies. Produce Daily Recruitment Activity Report based on the previous day Verify new subject status and avoid duplicate entry of subjects Submit new contact information of all subjects to Accounting to maintain the most recent and accurate data in all systems Enter all information submitted through RMS or hand-written Personal Information Profile (PIP) forms. File hand-written Personal Information Profile, inactivated and dental subjects, and keep records of referral and study filled payouts of different TKL clinical sites. Analyze current conditions of subjects that may qualify or disqualify subjects for certain studies Assign patch, photo and dental status that will help qualify subjects for specific studies Enter Subject Enrollment Log into SMS Compile monthly report for subjects who have completed their first patch or photo screenings and update classification in SMS. Classify subjects for patch, photo and dental codes based on disqualification reasons Review and update subject's data and where appropriate, redefine type of study subject to be called and inactivate subject if ineligible following screening. Update database to reflect referrals paid to participants who have referred subjects that have completed their first patch study. Submit referral fee requests and bonus fee requests to accounting Update database to reflect Study Filled status (off-line studies) and amount of payment. Submit study filled payment request. From October 2010 to January 2011 (4 months) Model-Customer Service Associate @ Responsible for product detail of patrons, resolution of issues, product returns, inventory management and replenishment input into the database and Customer Service. Set-up and dismantle of marketing and promotional media such as displays, special events, wardrobe selection assistance, etc. From December 2007 to July 2008 (8 months) Warehouseman, admin @ Inventory, admin work, morning computer start-up, shipping and receiving supplies used by other companies within the Marine Corps. From May 2004 to May 2005 (1 year 1 month) Bachelors of Science, Biology; Cell Biology Biostatistics Chemistry @ William Paterson University of From 2007 to 2010 AS, Sciences @ Passaic County Community College From 2003 to 2007 Continuing Education, Non-Matriculated @ William Paterson University of New Jersey Cecilia Kayali is skilled in: Microsoft Office, Word, PowerPoint, Excel, Customer Service, Outlook, Time Management, Data Entry, Typing, Regulatory Submissions, Clinical Research, Clinical Trials, FDA, Microsoft Excel, Microsoft Word