Michael E. Cotterell, Dds Email & Phone Number

Blandon, Pennsylvania, United States

Allentown, Pennsylvania, United States

Pennsburg, Pennsylvania, United States

Langhorne, Pennsylvania, United States

Philadelphia, PA

Albuquerque, New Mexico, United States

Baltimore, Maryland, United States

Bethesda, MD

Supported maintenance and upkeep of the Quality Management System.Maintained the Quality Assurance (QA) training program, document control, customer complaint program and CAPA program.Performed audits of clinical sites, laboratories, and vendors/suppliers, including virtual vendor audits.Gained admission into dental school at Maryland in 2016.

Bethesda, MD

Developed, with lab team, a FileMaker Pro relational database that stores and collects natural history, clinical trial, and research data for a NINDS translational neuroradiology lab on the NIH main campus.Organized 25 years of legacy data and demonstrated data integration with the lab's FileMaker Pro database.Established a proof-of-concept of REDCap EDC.

College Park, MD

Student in UMD's "Science in the Evening"​ program. Began as a part-time student in the fall of 2012. Continued as a full-time student in 2013. Returned to part-time status in 2014. Earned a 3.7+ GPA entirely in basic science coursework. Dean's List awarded in the spring 2013 semester and the fall 2013 semester.

Rockville, MD

Served as lead Data Manager for a NIDA study concerning intervention of HIV-infected drug users.Created electronic Case Report Forms in consultation with statistical and clinical teams using AdvantageEDC electronic data capture system.Provided QC of eCRFs and documented EDC quality checks in both test and training platforms.Developed data quality checks.

Rockville, MD

Internal auditor with a group that administered the NCI's central IRB. Created quarterly and annual Audit Plan, Audit Report, and Audit Schedule documentation system.Audited all aspects of the NCI central IRB for GCP compliance, including regulatory files, Helpdesk performance, and outcome letter timeliness.Developed CAPA tracking software with IT staff to.

New Hope, PA

Developed tools for collection and maintenance of QA audit information.Prepared trend analysis and metrics reports for distribution to senior management.Received external site auditor training.Left INC upon accepting an offer from The EMMES Corporation; started with EMMES in February 2008.

New Hope, PA

Audited clinical trial documents for this full-service CRO for 21 CFR 11 compliance, including: protocols, CRFs, data review guidelines, data management plans, SAS tables, statistical and medical reports, investigator brochures, ICFs, and SOPs.Audited internal regulatory files for FDA compliance, protocol specifications, and SOPs.Performed external audits.

New Hope, PA

Entry level QA auditor. Primary achievement was steering a 1,250-patient, 1 million variable database audit for a phase III diabetic neuropathy study. Trained and supervised ~6 auditors just for the project.Audited databases by comparing CRFs and data listings.Assisted managers to address audit findings from Sponsors and regulatory agencies.Maintained.

New Hope, PA

Assisted Regulatory personnel in maintaining internal files. Contacted site personnel to obtain requisite contracts and regulatory documents. Reviewed submitted documents to ensure compliance with FDA/ICH requirements. Prepared cover letters. Filed protocol deviations.Promoted in March 2005.

Princeton, NJ

Volunteered once a week delivering supplies from the central supply room to areas throughout the hospital. Assisted medical staff in loading and unloading medical supplies.

New Hope, PA

Compiled initial and follow-up records of AEs.Submitted records to Sponsor as required.Maintained files on drug safety reports.Reconciled inconsistencies between information appearing on paper AEs versus Sponsor's database.

Entered psychological study data obtained from questionnaires. Assembled materials for scientific presentations.

Bachelor’S Degree, Economics, Sociology, Psychology

Education record