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Online Resumes with "GCP ICH Guidelines"
CTA
Seeking for a challenging career in a progressive organization offering the opportunity for contributing my skills services to the organization and personal growth and to work sincerely with maximum effort using best talents and with a challenge to achieve required goals and targets, abiding to the decisions of seniors and to earn a good reputation what ever required.
Tags for this Online Resume: Develop, maintain and manage appropriate study documentation, Developing, writing and presenting the clinical trial protocols, Initiate, maintain and reconcile Trial Master File., Monitoring the trial throughout its duration which will involve visiting the Study centers on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise., Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other Data collection tools by careful source document review Monitor data for missing of implausible data., Complete Serious Adverse Event (SAE) reporting, process production of Reports, narratives and follow up of SAEs and managing the clinical data intermilitently as per 21CFR USFDA guidelines, Monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines., Independently perform CRF review; query generation and resolution against established data review guidelines on client data management systems as assigned Perform other duties as assigned by management., , maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
Senior Clinical Research Associate
Continue my service, as an educator and monitor in clinical trials for product development with major pharma/device company.
Tags for this Online Resume: Clinical Research Associate, GCP/ICH Guidelines, Bachelor Degree, Clinical Research Coordinator, ACLS Certification, Registered Nurse
Clinical Trial Professional
Detailed oriented Clinical Research Professional with medical education background and several publications. Extensive experience working on complex clinical trials in a critical care, cardiology and podiatry environment. Solid knowledge of GCP/ICH guidelines and FDA regulations. Well versed in medical terminology and medical procedures. Possess excellent communication and presentation skills.
Tags for this Online Resume: Clinical Research , Clinical Research Associate, Drug Safety Associate, Clinical Trial Associate, Research Scientist
Senior Research Nurse Coordinator
I'm a competent, organized, detailed oriented and efficient Clinical Research Nurse Professional with 10 years experience and proven administrative skills. Experience includes OB/GYN, Vascular Surgery, Podiatric and Ophthalmology Reserach. Excellent communication skills and proficient in time management and problem solving abilities. Knowledge of GCP and ICH guidelines, regulatory requirements, and the clinical trial process.
Clinical Research - 6 Years of Experience - Near 75287
PROFESSIONAL SUMMARY: A CRA with strong eye for detail and exceptional ability to interpret and follow instructions Possesses the ability to collect accurate data in line with client specifications excellent analytical and organizational skills knowledgeable in FDA regulations, GCP/ICH guidelines, seeking to join an organization that makes research subjects' safety its first priority. CORE QUALIFICATIONS: * Over 5 years exp...
Tags for this Online Resume:
Management, Clinical Research, Data Management, Protocol, Research, Assessments, Forth Programing Language, Good Clinical Practices, Monitoring, Training
Clinical Research
Summary of Qualifications Clinical Research Manager, Associate, Monitor, Coordinator, with over 25 years experience in the medical field and 21 years experience in clinical trials with extensive experience in the fields of Cardiology, Electrophysiology, Neurology, Urology, Autoimmune, Respiratory, Gastroenterology, Weight Loss, Diabetes, Women's Studies, Arthritis, COPD, Gynecology, Endocrinology, Rheumatology and Stem Cell...
Tags for this Online Resume:
Monitoring, Protocol, Cardiovascular, Clinical Research, Management, Pharmaceutical, Research, Therapy, Audit, Data Management, Medical Device, CRA, CTM, Clinical Trials
Clinical Project Manager-6 years-France
I supervised the development of several clinical projects in different therapeutics areas and in different countries (France, England, Italy, USA and Canada). I coordinated the clinical activities in respect with the budget, timeframe and regulations (SOPs, FDA-GCP and ICH guidelines). I trained CRAs, site investigators and CROs to ensure study protocol comprehension and compliance (initiation visits, co-monitoring). I plan...
Tags for this Online Resume:
clinical project, oncology, dermatology, cardiology
Postsecondary Teacher - 11 Years of Experience - Near 29376
CURRICULUM VITAE: Sharon Woodruff
Team excellence instructor, facilitator, and trainer. Proven managerial, interpersonal, and training skills.
Work History
Title: Senior Clinical Research Associate
Company/Location United BioSource Corporation Kansas City, MO/Regional United States
Dates July 2014 - January 2015
Accountabilities
Implement and monitor clinical trials for medications and devices to ensure sponsor and invest...
Tags for this Online Resume:
South Carolina, Training, New Hire , Business, Education, Postsecondary, Excellence
Featured Profile
You shouldn't have to read my entire resume to know I'm the one!
I absolutely enjoy what I do and look forward to work every week. I know there will be challenges and problems that my team and I will have to solve. I enjoy this career because every day is different. Every study requires a different amount of care and expertise/experience. I love the organization that comes with this career. I love having my own studies and organize documents according to company SOP as well as my own way...
Ideal Companies: Any Biopharma Company (start-up, or young companies) in Phase 1 or 2 of their studies
Tags for this Online Resume:
Instant Messaging, Data Analysis, Document Management, Good Clinical Practices, Good Laboratory Practices, Management, Medical, Medical Terminology, Microsoft, Microsoft Excel, Data Entry, Site Feasibility, Trial Master File Audit, Trial Master File, Routine Monitoring Visits, Bilingual, IWRS Systems, DSMB, analysis of PK data from different generations of Japanese subjects, Receiving Plasma samples and storing them in freezers, Urine collection and UA testing, Phlobotemy, ECGs, Dosing, Writing Visit Reports, Query data sheets, Resolving Queries within the SOP allotted time frame, Pippetting Fluids and shipping off with appropriate courier., CRA visit matrixes, Reporting numbers and statistics to Project Manager and Operations Manager, Reviewing Source Documents and making original source documents according to procedures in the protocol, Protocol review sessions, QA sessions daily with a volunteer from each department to go over daily data and tasks to make sure none were missed, Call subjects and perform AE checks according to timelines on protocol, Send critical documents to sites directly or through CRAs as demanded., Make progress matrices of site visits and site reports, Send reminder emails for upcoming visits for CRAs and internal deliverables, Coder
RESEARCH ADMINISTRATION PROFESSIONAL
Dedicated Clinical Research Professional with over 10 years' progressive experience managing multiple phases of clinical research projects. Possessing advanced education, leadership, management, diplomacy and organizational leadership skills and consistently demonstrating the highest level of personal and professional standards. Seeks a varied and challenging position that will enable me to consolidate my professional exper...
Tags for this Online Resume:
Oncology, Clinical Research, Diversity, Research, Consulting, Immunology, Medication Adherence, Planning, Policy Development, Strategic Planning, clinical, research, clinical trials, cro, regulatory
Clinical Research - 20 Years of Experience - Near 07042
Summary: * Expertise towards drug development and FDA, GCP/ ICH regulatory guidelines in the pharmaceutical industry Strong experience in a drug development performing different phases of clinical trials and Supported CTH in managing interactions with relevant line functions including Data Management, Drug Supply Management and Novartis Country Organizations and also performed Monitored pre-study, initiation, interim, close...
Tags for this Online Resume:
Clinical Research, Research, Oncology, Query, Cardiovascular, Filing, Management, Database, Database Maintenance, DSS
You shouldn't have to read my entire resume to know I'm the one!
I absolutely enjoy what I do and look forward to work every week. I know there will be challenges and problems that my team and I will have to solve. I enjoy this career because every day is different. Every study requires a different amount of care and expertise/experience. I love the organization that comes with this career. I love having my own studies and organize documents according to company SOP as well as my own way...
Ideal Companies: Any Biopharma Company (start-up, or young companies) in Phase 1 or 2 of their studies
Tags for this Online Resume: Instant Messaging, Data Analysis, Document Management, Good Clinical Practices, Good Laboratory Practices, Management, Medical, Medical Terminology, Microsoft, Microsoft Excel, Data Entry, Site Feasibility, Trial Master File Audit, Trial Master File, Routine Monitoring Visits, Bilingual, IWRS Systems, DSMB, analysis of PK data from different generations of Japanese subjects, Receiving Plasma samples and storing them in freezers, Urine collection and UA testing, Phlobotemy, ECGs, Dosing, Writing Visit Reports, Query data sheets, Resolving Queries within the SOP allotted time frame, Pippetting Fluids and shipping off with appropriate courier., CRA visit matrixes, Reporting numbers and statistics to Project Manager and Operations Manager, Reviewing Source Documents and making original source documents according to procedures in the protocol, Protocol review sessions, QA sessions daily with a volunteer from each department to go over daily data and tasks to make sure none were missed, Call subjects and perform AE checks according to timelines on protocol, Send critical documents to sites directly or through CRAs as demanded., Make progress matrices of site visits and site reports, Send reminder emails for upcoming visits for CRAs and internal deliverables, Coder
