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Online Resumes with "GCP Guidelines"



Clinical Trials Associate

Michelle Straka, BSHS, CPT 1163 Portsmouth Circle Medina, Ohio 44256 Cellular: (216) 337-2007 Home: (330) 722-2165 Email: dodgestealthrt1994@yahoo.com Linkedin account: http://www.linkedin.com/pub/michelle-straka/1b/964/aa2 Objective Obtain the position of Clinical Research Associate to further advance monitoring career. About four years additional experience in research as a study coordinator, regulatory coordina...

Sr. Director/Director Clinical Quality Assurance and Compliance

Over 19 years of Regulatory / Clinical Quality Assurance & Compliance / Auditing experience. Maintain an excellent knowledge base of all applicable Guidelines, FDA Regulations as well as best practices. I have prior interaction with the FDA, and EMEA/MHRA authorities, leading to successful outcomes. I am considered to be a strategic leader and planner effective in a team environment and customer service focused, with exc...

Tags for this Online Resume: Clinical Quality Assurance, Compliance, Auditor, GCP, Quality Systems, Director

Clinical Research Associate and QA with 1 year experience and M.Sc. in Science with 10 years' experience

To get a position as a Clinical Research Professional and involve in Canada pharmaceutical industry.

Tags for this Online Resume: ICH/GCP guidelines, FDA requirements , Design and revised protocol, Standard Operating Procedure , Case Report Form (CRF), Informed Consent Form (ICF), Adverse Events (AE) and Serious Adverse Events (SAE) , Data Managemnet, MS office, Phlebotomy, CPR, Recruit subjects

Clinical Pharmacologist (PhD)

A Study Co-ordinator (PhD in Pharmacology) with more than 2.0 year of experience in the pharmaceutical industry. Demonstrated ability to attain and maintain a working knowledge of GCP, schedule Y (Indian CDSCO guidelines), Clinical Trial Document (CTD), and applicable SOPs. Expertise in BA/BE studies, managing clinical trials data, formulating source documents and data collection charts and severe adverse event reporting. C...

Tags for this Online Resume: Clinical Pharmacologist, ClinicalPhamacokinetics, Clinical PK-PD, BABE studies, Phase III studies

Clinical Research Associate

To obtain a Clinical Research Position in the Minnesota Area.

Tags for this Online Resume: Knowledge of 21 CFR, Quality System Regulation (QSR), Medical Device Reporting, Regulatory Compliance , Regulatory Submissions , ICH GCP Guidelines

Clinical Research - 10 Years of Experience - Near 11801

Cover Letter Rupal brahmbhatt Respected sir/madam ,, My self Rupal Patel Brahmbhatt. I was working at Synchron Research Services a leading CRO of India. I have been the part of this organization from when it was established, and still I was working with the same organization from 12 years. I have been a part of more than 700 projects as well as clinical studies including USFDA submission projects. I have face the US...

Tags for this Online Resume: MS office, GCP, SOP, CRA, ICF, CRC

Clinical Research Associate - Entry level - Waterloo

Driven, dynamic, and detail oriented. Trained in ICH/GCP guidelines to monitor clinical trial processes. Actively seeking an entry level CRA position within clinical trial programs.

Tags for this Online Resume: ICH/GCP, Clinical Research, SOPs, Case Report Forms, Microsoft Office Suite, Phases I - IV trials, Recruitment

RN Medical Coder - 18 years experience

Remote Medical Coder experienced in with ICD-9CM, ICD-10, WHODrug, WHO-ART, COSTART and MedDRA coding practices. Knowledge of diseases, drugs, dictionaries, and coding conventions. Multiple compound ownership interfacing with Clinical, Clinical Data Management and Clinical Safety to ensure appropriate coding for report analysis. Responsibilities include the daily running of studies, documentation of all procedures, regular...

Clinical Research

PROFESSIONAL SUMMARY Persistent, Organized and detailed oriented professional interested to pursue a position as a Clinical Research Associate (CRA) with a pharmaceutical / biotechnology firm where I can utilize my medical and clinical research knowledge along with my strong technical and procedural skills in clinical monitoring to meet the growing needs for clinical trials of new drugs in multiple therapeutic areas. CORE Q...

Tags for this Online Resume: Protocol, Clinical Research, Research, Complaints, Documentation, Interactive Voice Response, MDR, Voice

Clinical Research

Experienced Clinical Research Associate seeking a challenging and rewarding Clinical Research Associate (CRA) position that will utilize my clinical site monitoring and general management skills and experience to coordinate, monitor and manage all aspects of clinical trials in accordance with the ICH-GCP guidelines, FDA regulations, standard operating procedures and study protocol.

Clinical Research - 15 Years of Experience

Focused on obtaining a position as a Clinical Research Associate. Detail oriented with the ability to plan organize coordinate and manage projects according to priorities. Ongoing and consistent promotion of team work efforts. Excellent Communication and Interpersonal skills. Excellent oral and written communication skills with the ability to communicate effectively with medical personnel. Quick learner with the ability to ...

Tags for this Online Resume: Documentation, Management, Cardiovascular, Cardiology, Clinical Research, Distribution, Good Clinical Practices, Research

Clinical In-house Monitoring - 4 Years of Experience

Seeking a position in a globally focused organization that will utilize my qualifications while offering several opportunities to integrate personal enrichment with professional goals.

Tags for this Online Resume: Clinical Research, ICH GCP Guidelines, Schedule Y, eCRF, EC Submission, Site coordination, Inspection, Project Coordination