Omeca Best

908-***-****

O acxhgp@r.postjobfree.com

To obtain a position in clinical research with future advancement. Excellent 2 years experience pertaining to clinical studies, and clinical data management. SUMMARY OF QUALIFICATIONS:

•Good Clinical Practice Guidelines • International Conference on Harmonization

•Food and Drug Administration form • Electronic Data Management

•Case Report Form • Institutional Review Boards

•Monitoring of Clinical Primary Investigator •Effective Clinical Trials Studies

● Study monitor to ensure that all changes to CRF’s are made properly initialed, dated by the investigator or authorized member of the site staff.

● Review Source Document and check data recorded in the case report form against data found in source document.

● Inspect regulated binder for all essential IRB approved documents.

● Input queries of Clinical data management of mismatch information.

● Follow up for corrections, and close out of the queries.

● Document adverse events and serious adverse events.

● Inspect site for clinical study, initial visit, and final visit.

● Report to Sponsor and Institutional Review Boards all serious adverse events.

● Review laboratory kits and laboratory supplies.

● Study two Clinical Trials Pain Management, and Respiratory, phase II.

● Maintain timely effective communication, and organizational skills.

● Adherence to Standard Operating procedures.

● Coordinate work with CRO and staff team.

E XPERIENCE

Svelte Medical – New Providence, NJ Clinical Research Associate 2014 2015

● Clinical research coordinator or patient recruiter

● Understanding of pain management clinical studies and medical terminology

● Experience speaking with patients face to face, outside of clinic environment

● Experience coordinating community events

● Monitor a clinical trial. Ha the opportunity to work on multiple trials in multiple therapeutic areas. Demonstrate great organizational and communication skills. training and check that the investigator knows exactly what has to be done. Make sure that each site is meeting goals of enrolling patients in the sponsor’s trials, and adhering to GCPs. Provide feedback to cross functional team on Protocols and other study documents and reports.

Clinical Trials Services, PA Clinical Research Associate 2012 2014

● Review the Protocol and understand assessments.

● Perform regular reviews of data entered by investigational site staff screening.

● Interact with site staff, clients, vendors, and internal study team members.

● Assist in the management of the day to day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities, liaison between Clinical Operations Manager and CRO.

● Assist in the management of the Trial Master File.

● Ensure the training of CROs/investigators on protocol, regulatory, SOPs and data issues.

● Review regulated binder and ensures tracking of ongoing site issues. Johnson and Johnson – Raritan, NJ Auditor 2010 2012 Quality control use instruments, tools, gauges, sterilization, spreadsheets, microscope And methods for quality control testing. Complete documentation of test and inspection result. Conduct audited for packaging, and validation. Work in clean room setting Good Clinical Practices.

Executive Office of Review Newark, NJ Legal Assistant 2000 2010 Maintain legal case files updates and data to reflect legal administrative status of applications. Track legal correspondence, documents, and information. I utilize legal reference files, the internet, electronic databases, and automated systems. Compose or processes a variety of legal forms, I input data analyze data, and maintain systems. I receive and answer inquiries in person and by telephone. I advise and assist on issues of a general administrative nature, such as the status of pending case.

Education: Fraud, Waste and Abuse Training, 2012, 2013, 2014, 2015, and 2016 AHIP

(America’s Health Insurance Plans) Course Marketing Medicare Advantage and Part D Prescription Drug Plans: Understanding Medicare Basics, Plan Types, and Marketing/Enrollment Requirements Certified 2012, and 2013, 2014, 2015, 2016 Macroeconomia 2014, Medical Terminology 2014, Clinical Research 2010 Microeconomics 2014, Web CE New Jersey Department of Banking and Insurance, Medicare, Medicaid and Medicare Supplements 24 Credits, CMS Medicare Marketing Guidelines 2012 and 2013 Classroom: Licenses 2 Go University, Dallas, Texas 2008 Certified and Licensed: Health/Sickness Producer #1030378

Primerica University, New Jersey: 2004 Certified and Licensed: Life Producer #1030378.