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RssClinical 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 coordinator and legal/budget negotiator. Education & Training 2008 Phlebotomy Technician (certification number 260131080018) 2006, CITI Course in the Protection of Human Research Subjects, University Hospitals Case Medical Center 2005, Bachelor of Science, Health Science (minor in Psychology), Cleveland State University, Cleveland, Ohio 2004 Certification in Medical Transcription, Education Direct, Scranton, PA 2003, Associate of Arts, Cuyahoga Community College, Cleveland, Ohio Current Position 2011 – Present, Clinical Trials Assistant – CROfessionals, LLC Work responsibilities include: Support Project Managers and Clinical Director in the conduct of the clinical trial, conducting clinical trial study set-up under supervision of Project Manager, Create study specific forms, documents and presentations, ensure regulatory compliance of study documents, co-managing sites under supervision of Project Manager, prepare interim queries, assist with preparing payments to clinical sites, collect, review, file, track and archive electronic and paper copies of clinical trial documents, review initial data listings against CRFs, track study activities, draft newsletters, assist with drug shipments to clinical sites, perform PQVs, SIVs, SMVs, and COVs independently, complete data transmittal and CRF forms for submission to Sponsor, and other duties as required. Prior Positions 2009 – 2011, Clinical Trials Coordinator - University Hospitals of Cleveland Work responsibilities include: Complete IRB submissions accurately and promptly, ensure that all new protocols, amendments, adverse event reports, investigational drug brochures and annual reviews are approved by the Institutional Review Board and other department and federal agencies as appropriate. Prepare appropriate documents needed to obtain approvals. Skills include: Knowledge of ICH/GCP guidelines for human research. Understanding of Code of Federal Regulations for Human Subjects. Understanding Phases I-IV drug development processes. Proficient knowledge of medical terminology, and good clinical practices. Excellent time management skills, detail oriented, quality conscious, and excellent communication skills. 2007 – 2009, Program Assistant – University Hospitals of Cleveland Work responsibilities include: Coordinate and administer research study associated activities. Consent subjects to clinical trials. Process and ship specimens, obtain vital signs, perform EKG’s, blood draws completed per study protocol, complete electronic case report forms accurately, negotiated legal and budget contracts and identify potential subjects for clinical trials. Skills include: EKG, phlebotomy, joint assessment skills, and process blood and urine specimens. 2008 – 2011, Health Unit Coordinator - Marymout Hospital and Hillcrest Hospital Work responsibilities include: Accurate entry of patient tests, laboratory requests, admissions, discharges and transfers, and coordinate all activities at nurse’s station. Skills: Flexible, versatile and respond quickly to changing priorities. Organized, accurate, detail oriented, ability to prioritize, multi-task, meet demands and work in a high stress, high volume environment, and conscious of patient rights and privacy. 2009 – 2011, Clinical Trials Coordinator - Kelly Services (Case Western Reserve University) Work responsibilities include: Prepare, process and submit IRB paperwork for mass amendments, track submissions using electronic database, carry out special projects as needed and create spreadsheets detailing progress of projects. Skills: Superior computer skills, proficient in Microsoft programs, reliable, motivated, and ability to work with little supervision. 1994 – 2005, Clerk III - Key Bank Work responsibilities include: Processed, balanced, and mailed various customer statements, trained new employees, assisted in the development of a system to track the completion of work, researched shortages and completed end of night reports. Therapeutic Areas with Research Experience Oncology, Blood Products, and Rheumatology In-house Training Clinical Trials Assistant Training PQV, SIV, SMV, and COV Training Clinical Study Management Training


Medina, OH

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Medina, OH