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Online Resumes with "ICH GCP"

Drug Safety / Pharmacovigilance - RTP, NC

Dynamic, enthusiastic, and performance-driven Doctor of veterinary medicine intent on transferring 10 years of knowledge and experience in a clinical setting to a challenging career working in the Pharmaceutical or Contract Research Organization industry with a progressive company offering opportunities for growth and advancement. Outstanding team player and communicator with highly detailed documentation skills seeking t...

Tags for this Online Resume: Medical terminology, ICH/GCP guidelines, DIsease states, Pharmacology, Customer service, Medical writing

Clinical Research, Raleigh

To Obtain a position congruent with my education and level of experience in the Clinical Research field.

Tags for this Online Resume: Clinical Research Associate, Clinical Research Associate, ICH-GCP Guidelines, ICH-GCP Guidelines, Source Verification, Source Verification, Regulatory Document Maintenance, Regulatory Document Maintenance, Site Initiation Visits, Site Initiation Visits, Drug Accountability, Drug Accountability

Clinical Research 14 years experience

My objective is to use my extensive knowledge of clinical research, FDA, ICH, and GCP guidelines to obtain a career in the Pharmaceutical/Biotech industry.

Tags for this Online Resume: Clinical Reserach, IRB, Human Subject Protection, Audit, Monitor

Home Based Clinical Research Associate (CRA/Sr CRA) - 20 years experience

I am an RN, certified in clinical research through ACRP. I have 15 years of management experience at a major cancer center and 5 years of clinical monitoring experience both in the field and in-house. For the purpose of clarification, I also have 5 years of clinical research experience as a study coordinator in medicine outside the field of oncology I would like to find a position that matches my level of experience in the...

Tags for this Online Resume: ICH-GCP, Clinical Research Associate, ACRP Certified, Regulatory, Medical Oncology, Medical Device

Clinical Trial Specialist / CRA _ Home based

Achieve the successful of clinical trial and ensure the subject safety and the high data quality by working closely with each clinical site and ensure that all the tasks are being conducted in accordance with the clinical trial protocol , ICH GCP guidelines and local regulations.

Clinical Trials Associate

Michelle Straka, BSHS, CPT 1163 Portsmouth Circle Medina, Ohio 44256 Cellular: (216) 337-2007 Home: (330) 722-2165 Email: Linkedin account: 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

Expert Biostatistician

Statistical analysis in pharmaceutical industry

Tags for this Online Resume: Biostatistics, SAP, FDA, NDA, ICH/GCP, SAS

Clinical Research Associate - 10 plus years Dallas, Field Application Specialis/Fiels Service Engineer - 5 years plus, San Francisco & Dallas

I am a strong self-starter with over 10 years’ monitoring experience with monitoring phase I to phase IV for pharmaceutical companies, biotech companies and CROs. I also have over 5 years’ experience as a Field Application Specialist with a biotech company which is a similar position as a Pre-sales and Medical Device Expert at a biotechnology company. I work well independently or in a team environment. I am presently lookin...

Tags for this Online Resume: Dallas/Ft. Worth, TX, Clinical Research Associate, Regional Clinical Research Associate, GCP, ICH, FDA, Code of Federal Regulations, Clinical Research Studies, Therapeutic Areas

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 Research Compliance Professional - BSN

Operating Room RN with more than 12 years’ in clinical research/regulatory and emphasis on safety monitoring, review and analysis.

Tags for this Online Resume: BSN, nurse, safety, adverse events, clinical trial, research, educator, ICH-GCP, FDA, IRB, regulatory affairs, medical record review

Clinical Research Professional- 20 years experience- Memphis

Clinical research professional with over 20 years of experience in both industry and academia. Responsible for all audit activities for multiple phase 1-3 clinical trials. Responsibilities include but are not limited to ICH/GCP compliance. Reviews key study documents such as protocols, informed consents, CRFs, monitor reports, and CSR. Presents protocol and GCP training at Investigator meetings. Mentors and trains junior qu...

Tags for this Online Resume: GCP, FDA submission documents, Drug safety, GLP, NDA, Auditor