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...
Results-oriented, decisive leader and competent clinical research program manager with 10+ years of experience facilitating and managing cross functional project teams within academia, biopharmaceutical and aerospace industries, drug development and testing, biomedical research, and health education. Highly focused with ability to lead teams in project strategy definition, direct and guide program core and sub teams to deli...
Tags for this Online Resume:
Clinical Research management, Project management, coordination, Quality Assurance, clinical trials, Research data analysis, Quality Control
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.
I want to ensure that sites that I monitor are completed accurately according to Code of Federal Regulations and GCP/ICH.
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
Statistical analysis in pharmaceutical industry
Tags for this Online Resume:
Biostatistics, SAP, FDA, NDA, ICH/GCP, SAS
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...
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Dallas/Ft. Worth, TX, Clinical Research Associate, Regional Clinical Research Associate, GCP, ICH, FDA, Code of Federal Regulations, Clinical Research Studies, Therapeutic Areas
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
To be involved in clinical research
Tags for this Online Resume:
clinical research associate, clinical team leader, senior clinical research associate, monitoring , FDA regulations, Phase 1- IV studies, site selection to site closeout, maintain GCP ICH compliance, GCP ICH compliance
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
