Clinical Research Pharmacy

Y. CEYLA CUBUKCU, RPh

To whom it may concern:

I am a New York and New Jersey Board certified pharmacist. I have extensive experience in clinical research for over 10 years, first as a "Clinical Research Specialist" at PPD, followed by my position as a "Clinical Scientist" at Merck. Attached is my resume for your review. As a pharmacist, I believe in close relationships with patients and giving them the personal touch that they need.

My experience as a pharmacist and clinical scientist along with my personnel skills make me a very good fit for this position.

I can be reached at 917-***-**** or via email ********@*****.***.

Thank you for your time,

Y. Ceyla Cubukcu, RPh

Y. CEYLA CUBUKCU

Phone: (917) 753- 1875 E-mail: ********@*****.***

March 2017- Present

Staff Pharmacist

Prohealth Pharmacy New York, NY

New York and New Jersey Board Certified Pharmacist with Pharmacy degree and 10 plus years of clinical research experience providing top-notch pharmacy services in retail setting. Ensure compliance with Company and legal policies, procedures, and regulations for the pharmacy department. Maintain patient confidentiality as required. Focus on Medication Therapy Management. Model, enforce, and provide direction and guidance to technicians on proper service approaches and techniques to ensure that customer needs, complaints, and issues are successfully resolved within appropriate guidelines and standards. Provide pharmaceutical care to pharmacy customers, patrons from the local community as well as to those working at local Financial firms, including processing and accurately dispensing prescription orders, counseling patients and caregivers regarding health care and prescription medication needs, following company policies and maintaining confidential information, maintaining controlled medication and required documentation. Maintain a clean, neat, organized and safe work environment. Demonstrate working knowledge and understanding of pharmaceuticals and pharmacy practice standards.

April 2014- June 2017

Staff Pharmacist

Downtown Pharmacy Jersey City, NJ

Responsible for consulting with physicians and patients with regard to medication dosage, drug interactions, medical equipment, disease management and potential side effects of prescription and OTC medications. Dispense and compound prescriptions, and maintain accurate patient records, dosing information and directions for use. Interact with insurance providers concerning billing/reimbursement issues. Organize and direct technicians' and intern's work flow. Review patient immunization history and administer vaccinations. Processes, approves, and makes standard recommendations in response to physician orders using clinical judgment. Adhere to established regulatory and accreditation standards. Follow and may make recommendations on pharmacy best practice standards to optimize patient care and reduce cost.

December 2007- April 2012

Clinical Scientist Rahway, NJ

Merck

Responsible for developing detailed study design specifications, medical monitoring of study data, and summarizing results for assigned clinical trials. Served as a key liaison between Clinical Sciences and other functional areas represented in the clinical trial team. Provided guidance on the scientific aspects of the implementation and conduct of clinical trials, while ensuring appropriate input from the clinical research physician for decisions requiring medical judgment. Authored clinical sections of protocols, regulatory agency update reports, and misc. clinical documents (Clinical Investigator Brochure, etc.). Responsible for appropriate application of standards in the protocol, and other regulatory documents. Worked closely with contributing authors such as statistician, clinical research physician, Global Supplies Operations, Basic Research, Clinical Pharmacology. Represented Clinical Sciences as a member of the clinical trial team for assigned protocols. Served as scientific subject matter expert in the development of clinical trial deliverables produced by other functional areas (to include data collection tools, vendor specifications, site assessment questionnaires, clinical study report tables,etc), to ensure consistency with the protocol. Participated in feasibility assessment of protocol design with subsidiaries and/or potential clinical investigators. Presented study procedures at field monitor and investigator meetings. Worked closely with protocol statistician, identify and confirm data exclusions of “protocol violators” from statistical analysis. Provided scientific expertise to field staff in support of ongoing study execution with focus on protocol specific safety and efficacy endpoints. Assisted in the resolution of issues that arise in the implementation and conduct of studies that require in-depth understanding of study design. Reviewed and summarized study data to identify potential scientific trends, issues, and outliers during recruitment and through the conduct of the study.

April 2002- December 2007

CRA Specialist Remote out of Maryland, MD and New York, NY

PPD

Participated in the conduct of a multi-center Phase II and III dose and schedule selection study to evaluate the safety, efficacy and/or immunogenicity in volunteers. Performed Pre-Study, Initiation, Interim Monitoring, Booster and Close-Out Visits according to applicable Standard Operating Procedures (SOPs) and FDA guidelines. Reviewed trip reports. Provided resource for management, sites, and fellow CRAs. Provided study updates and follow up to the sponsor. Leaded sponsor and full team meetings. Provided mentoring and extensive training to management and CRAs including protocol, therapeutic, vendor and field training. Created monitoring tools for the team. Generated newsletters, global updates to the Investigators weekly.

LICENSE

New York State Board Certified Pharmacist

New Jersey Board Certified Pharmacist

New Jersey Board Immunization Certification

New York Board Immunization Certification

CONFERENCE SPEAKING ENGAGEMENTS

Altinbas University School of Pharmacy Istanbul, Turkey

Ege University School of Pharmacy Izmir, Turkey

EDUCATION

Ege University, School of Pharmacy, Izmir, Turkey

THERAPEUTIC EXPERIENCE

Endocrinology: Osteoporosis (Phase III), Sarcopenia (Phase III)

Respiratory: Asthma (Phase III), Seasonal Allergic Rhinitis (Phase III)

Sense Organs: Keratoconjunctivitis sicca (Phase III)

Vaccine: Influenza Vaccine (Phase II), Plague Vaccine (Phase II)

PROFESSIONAL AFFILIATIONS

Member of the Association of Clinical Research Professionals since 2002

COMPUTER EXPERIENCE

Operating Systems: MicroMerchant PrimeRx, Windows, MS-DOS, Internet

Software: Microsoft Word, Excel, PowerPoint

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