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Click here or scroll down to respond to this candidateCandidate's Name
GRC-Home-BasedSite Management Associate IIBiographyCandidate's Name has 1 year and 8 months experience within Syneos Health as CRAI/II. Additionally, she has over 12 years of clinical experience; including 10 years as an Ophthalmology Clinical Research Coordinator and over 5 years of medical office experience and management.She has worked on a wide variety of therapeutic areas for both pharmaceutical clinical trials(phases I, II, III) and medical device studies. Her therapeutic areaexperiences include: Ophthalmology and pediatrics.As a CRA I, Olga participated in the global three-month CRA Training Institute (CTI). This intensive training program covers the theoretical and practical knowledge of the CRA duties based on Syneos Healths global standard. The successful completion of the program, which includes multiple on-site training visits with experienced CRAs, will result in IAOCR (International Accrediting Organization for Clinical Research) accreditation. She is currently a Site Management Associate II with Syneos Health utilizing skills from previous experiences to ensure outstanding customer service, quality deliverables, and targets met.These experiences have culminated in Candidate's Name the ability to positively impact and create added value to assigned studies in the form of accelerated timelines, cost reductions, enhanced site and patient engagement, patient diversity, and optimal data quality.Professional ExperienceJun 2022 - Present Syneos Health (Greece)Site Managing Associate II- Perform site management activities in compliance with the Company and Sponsor (if applicable) Standard Operating Procedures (SOPs) and Work Instructions (WIs).- Assure compliance with local regulations and appropriate guidance depending on assigned study design / classification. May include Good Pharmacoepidemiology Practices (GPP) and/or International Conference on Harmonization - Good Clinical Practice (ICH-GCP).- Conduct site management activities as per agreed Scope of Work (SoW), Site Management Pl an (SMP) and relevant guidelines.- Site identification - may contact sites to obtain interest in study participation, confirm contact details, retrieve documents for consideration, etc.- Site Qualification - Ensures selection of appropriate sites for assigned studies.Site Start-Up - With minimal supervision, ability to perform activities for assigned sites working with study start-up and regulatory.- Conduct of all remote and on-site monitoring activities through all study stages.- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and SMP, within required timelines. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.- Demonstrates diligence in protecting the confidentiality of each subject/patient.- Assigned sites data review, assisting with data query resolution and missing data follow-up (only as applicable). Review data using data trend reports and knowledge of site practices. Ensure the resolution of data queries within agreed timelines. Utilize available hardware and software to support effective study data collection and review.- Maintain effective, accurate and timely communication with site staff and project team, and ensure appropriate issue escalation and resolution as per SOPs with a focus on issue prevention. - Maintains clinical tracking and management systems.Ensure all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements/data collection tools and safety reporting. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.-Prepare for, attend and participate in Investigator Meetings and/or sponsor face-to-face meetings.- As required, collaborate and build relationships with Sponsor affiliates, medical science liaisons, and local country sponsor staff.- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Clinical Operations Lead or designee, to changing priorities to achieve goals / targets.- Identify and communicate out of scope activities to Clinical Operations Lead.- Attend, contribute to and present at study and department meetings.Apr 2021 - Jun 2022 Syneos Health (USA)Clinical Research Associate I- Completing project activities associated with monitoring functions of Phase I-III clinical research studies. (CNS)- Fully understanding the drug development process.- Performing monitoring functions to assess the progress of clinical studies at assigned investigative sites (either on site or remotely) to ensure clinical trials are conducted, recorded,and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.- Mentoring and/or training less experienced employees.Oct 2019 - Mar 2021 Prism Vision Group- NJ RetinaClinical Research Coordinator- Led recruitment efforts and screened potential patients for study eligibility for Phase I, II and III clinical trials. Monitoring documentation; including, regulatory, IRB submission, CRFs, ICF and SOPs.- Reviewed protocol compliance, documented deviations and implemented corrective actions according to GCP and 21 CFR regulations.- Completed and documented assessments on study subjects, as per protocol which included ophthalmic examination and/or lab specimen collection and processing.Oct 2016 - Sep 2019 Columbia University Medical Center- Department of OphthalmologyClinical Research Coordinator-Responsible for administrative oversight of the Department of Ophthalmologys Clinical Trial Unit; including, conducting clinical research examination, counseling of patients and consenting.Ensuring that clinical research studies were conducted in accordance with assigned study protocols, operation manual and clinical research principles.- Served as liaison between patients, principle investigators, IRB, Sponsors, Clinical Directors, laboratories and other participating research entities. Ensuring that all staff is trained, supervised and directed in the performance of their duties- Examined patients and prepared them for doctors examinations; including, checking vision, intraocular pressure, angle closure, refraction, medical history, dilation, eye muscle movement, visual distortions and pupillary responses.- Assisted glaucoma physicians in minor office surgical procedures and corneal speacialist physicians in crossling surguries.Jul 2014 - Aug 2016 Chelsea Eye and Cosmetic SurgeryCertified Ophthalmic Technician-Coordinated scheduling of patient appointments and surgeries.- Performed a variety of routine tests using ophthalmic instruments that provided diagnostic information; including, intraocular pressures, basic motility, visual fields, OCT and autorefraction tests, A-Scan ultrasonography, fundus photography, manifest refraction and corneal topography.- Assisted the physician during diagnostic and minor surgical procedures; including, instrumentation, sterile preparations and documentation.Jun 2010 - Jul 2014 Pamel Vision and Laser GroupClinical Research Coordinator and Surgical Counselor-Scheduled and coordinated patients for surgical ophthalmic procedures; including, collecting data, examining patients and counseling them for pre/post-operation. Utilizing and manipulating advanced medical ophthalmic equipment; such as Heidelberg, Fundus camera, Visual Field, Auto-refraction and Diopsys machines.- Counseled and recruited patients for ophthalmic clinical trials.Examined subjects, collected data for trials and kept and maintained study materials and study data forms/binders. Assisted during ophthalmic surgical clinical research procedures and adhered to surgical/clinical trial protocols.- Liaison between medical practice and IRB, making sure to adhere to proper clinical trial protocol while developing a strong partnership.Jan 2009 - Jun 2010 Park Avenue PediatricsFront Desk Manager-Provided customer service, such as greeting patients and answering telephones, preparing patient paperwork and insurance, handling billing issues, preparing patient charges and ensured HIPPA compliance, ensuring copays and balances were paid and entered into ledgers, preparing deposit slips and closing reports- Dealt with patient insurances for eligibility and benefits detail- Ensured supplies were in stock and the office maintained a high level of efficiency.Sep 2007 - Aug 2008 Pediatric Healthcare of QueensPractice Administrator/manager-Managed the day-to-day operations of the practice by supervising employees and assigning responsibilities. Ensuring proper clinical and laboratory administration was maintained. Implementing an EMR system for the practice in order to create increased efficiency and productivity- Conducted meetings with pharmaceutical companies in order to create good relationships and interacted with insurance companies for patient and practice specific needs.- Interacted with patients concerning issues or concerns and served as liaison between patients and doctors.Aug 2005 - May 2006 New York Department of Health and mental Hygiene- Hospital DivisionIntern- Hospital Inspections-Worked closely with hospital inspection teams, specifically for dialysis and laboratory facilities as part of Masters program in Public Health.Aug 2003 - Aug 2005 Kassapidis, Sotirios MD- Internal Medicine and Pulmonary specialistMedical assistant/ Office coordinator- Supervised laboratory responsibilities and ensured proper utilization of specimens. Performed EKGs and Holter monitors on patients, prepared blood samples for laboratory analysis, and collected urine samples and cultures from patients- Prepared patient charts, exam rooms and patients for exams. Createdreferrals, authorizations and appeals through various insurance companies for patients- Scheduled patients for examinations and testing and approved medications through pharmacies. Informed patients of blood test, radiology and cardiology test results and authorized patients to receive home care assistance and nursing services.Dec 2001 - May 2002 Fordham University- Biology DepartmentIntern at microbiology laboratory of Dr. Raj KandpalPrepared Ecoli bacteria cultures, competent cells and plasmids. Performed transformations, DNA gel electrophoresis, PCR, ligations, and restriction enzyme digestions.Sep 2000 - May 2001 Fordham University - Biology DepartmentIntern at Sleep/neuroscience laboratory of Dr. Levente KapasIndependent research in sleep, investigating correlation between sleeping patterns and memory.Therapeutic ExperienceDevice-Intraocular DeviceOphthalmology-Atrophy, Geographic-Cataracts-Diabetic Retinopathy-Dry Eye-Glaucoma-Macular Degeneration, Age-Related-Macular Edema, Diabetic-Rare Disease-Retinitis Pigmentosa-Vision LossLanguagesEnglish - Speaking, Reading, Writing- NativeGreek - Speaking, Reading, Writing- NativeEducation2007St. Georges University Medical School - GrenadaMasters - Public Health2003Fordham University - United StatesBachelor - Biological Sciences |
