Quality Assurance Manager

DAWN SESSION

**** ***** ** #**** • San Antonio, Texas 78258 • 832-***-**** • ***********@*****.***

OBJECTIVE Seeking a Clinical Trial Assistant position that will utilize my experience and talents with an organization providing career advancement opportunities.

SUMMARY Offering a Bachelor of Science degree in Biology with post graduate Clinical Research Administrative studies, coupled with successful experience as a Clinical Research, Quality Assurance Analyst and a Clinical Research Coordinator(Clinical Trial Manager).

• Proficient expertise in major laboratory areas. Examine specimens, operate complex electronic equipment, computers, and precision instruments pertinent to laboratory studies. Ensure strict quality control measures in compliance to all state and federal requirements i.e. FDA, OSHA and CLIA; Good Clinical Practices (GCP) & Standards of Operations (SOP).

• Technology expertise includes DNA sampling (Gel electrophoresis); Electronic Pipettes; human drug trial research. Regularly analyze studies and manage briefings, report writing, quality assurances, and research tracking issues. Computer literate: MS Office Suite.

• Talented communicator and educator with demonstrated abilities to manage teams in science/ laboratory discipline. Detail simple to complex materials for up to 60-member audiences.

EXPERIENCE

2010 to Present Clinical Research Coordinator, Sylvana Research Associates San Antonio, TX

Coordinate with external monitors and internal quality assurance to assure compliance with protocol, SOPs, regulations and guidelines.

Collect, organize and maintain all essential documents required for study regulatory files.

Serves as liaison between sponsors, investigators, departmental research personnel and other individuals assigned to the study.

Coordination and management of the clinical study, communications with the sponsor, and authorities, subject visit coordination, and time management.

Coordinate the activities of research personnel to ensure quality patient care and adherence to research CGP principles.

Interact with sponsor Clinical Research Associate to facilitate the sponsor monitoring and database clean-up process.

Attend sponsor Investigator/Study Coordinator meetings as needed for assigened protocols.

Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.

Manages activities of study within defined budget.

2006 to 2010 Science Teacher, (Secondary Level), Houston I.S.D. Houston, TX

• Instructed a full range of Science and Laboratory curriculum to 185 students per year.

• Evolved interesting curriculum, lesson plans, and classroom activities on subjects that included Biology, Anatomy, Physiology, and Laboratory Sciences. Managed research initiatives and special projects to encourage enriched learning experiences among students.

• Directed learning for an inner city school with many students rated as low performers due in part to low economic living conditions. Overcame significant language barriers.

• Developed and implemented lesson plans to accommodate a broad range of learning levels. Created syllabi per state of Texas guidelines and science teaching standards.

• Co-team member on the science curriculum team tasked with developing district-wide biology and anatomy science curriculum. Significantly improved teaching methodologies which subsequently heightened student interest levels.

• Designed Science Dept. forms and maintained accurate student profiles and assessment data. Managed annual field trip budgets totaling $1,800.

• Prepared laboratory exercises, PowerPoint lectures, demonstrations, and activities. Developed and implemented student centered lessons that increased standardized test scores from 55% passing to 94% passing within two years.

• Proactively supported and participated in open houses, field trips, and regular parent / teacher conferences. Applied positive reinforcement throughout tenure.

• Honored with a monetary award of $17,500 for dramatically increasing Science TAKS scores.

2005 to 2006 Assistant Manager, Walgreens Co. Houston, Texas

• Managed all aspects of a high volume retail pharmacy supported by 20 employees. Accountable for inventory, administrative, fiscal, merchandising, and personnel actions.

• Functioned as a Pharmacy Technician responsible for filling medication orders as required.

• Directed store audits, loss prevention, and implemented promotions and special events.

• Responsible for store opening/closing in addition to managing customer complaints.

• Selected over peer professionals as a key store troubleshooter after Hurricane Katrina. Successfully restarted retail operations in hurricane affected areas.

2003 to 2005 Research Technician, Bioassay Laboratory, Houston, Texas

• Recruited from a highly competitive 60-member candidate pool as a laboratory researcher.

• Developed and maintained laboratory tests and documentation ensuring GCP were followed.

• Followed Standard Operating Procedures during drug evaluations before submitting laboratory reports to the FDA. Prepared media and cultures for lab and analyzed test results.

• Executed drug versatility tests using human tissue and blood in 32 separate studies.

• Collaborated with 4 organic chemists, 4 staff physicians, laboratory pharmacists, and other support team members to successfully earn approval of drug trials.

EDUCATION • Bachelor of Science in Biology (minor in Chemistry), Sam Houston State University, 2005

• Pursuing a Masters Degree in Clinical Research Administration, Walden University, (Estimated graduation 2011).

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