Clinical Research Associate Resume
Cell
PROFILE
Goal-oriented team player with a diverse medical background. Strong communicator, persuasive and adaptable. Self-motivated, energetic, and attentive to the needs and views of others. Ability to listen, identifies issues or problem areas, and implements innovative solutions. Professional, personable, and articulate.
EXPERIENCE
- to -: Amgen, Thousand Oaks, CA (Contract Position)
Quality Assurance Monitor/CRA: TREAT (CKD and T DM) Phase III Trial. Assuring regulatory compliance with corporate SOPs, FDA, and ICH guidelines. Inspection of CRFs to verify adherence to the study protocol; completeness, accuracy, and consistency of the data; and adherence to local regulations on the conduct of clinical research. Assist in the preparation and review of study protocols, investigator brochures, informed consent forms, case report forms, clinical study reports, annual reports, various study materials, and monitoring tools. Collaborate with investigator and other departments such as Regulatory Affairs and QA to address project needs.
- to -: Boling Clinical Trials, Upland, CA
Clinical Research Coordinator/QA: CRC for the following studies: Novartis (Pain associated with Osteoarthitis) Phase III Trial, AstraZenica (Cardiovascular) Phase II-III Trial, Labopharm (Osteoarthritis) Phase III Trial, Bristol-Meyers Squibb (Rheumatoid Arthritis) Phase IV Trial. Screen subject for studies and assist investigator in determining whether subjects meet inclusion/exclusion criteria. Discuss study and conduct, ensure informed consent procedures and protocol is implemented in accordance with ICH/GCP guidelines and HIPPA regulations. Collect and monitor test results, perform data collection, correction of data queries, make sure all materials are available for new studies, chart preparation and recording, maintain and organize CRFs, track follow-up and reporting of Adverse Events and Serious Adverse Events. Assist in creating spreadsheets that capture protocol specific data, conduct histories, and make sure all study visit procedures performed. Obtain vital signs, ECGs, laboratory testing, obtain and prepare shipping of biological specimens, order supplies and drugs as needed. Administer investigational reimbursement.)
QA Duties: Inspection of CRFs to verify adherence to the study protocol; completeness, accuracy, and consistency of the data; and adherence to local regulations on the conduct of clinical research. Assist in the preparation and review of study protocols, investigator brochures, informed consent forms, case report forms, clinical study reports, annual reports, various study materials, and monitoring tools. Collaborate with investigator and Regulatory Affairs to address project needs.
- to -: Dermatology Associates, San Diego, CA
Medical/Surgical Tech.: Operation and maintenance of the following Lasers: V-Star, V-Beam, Versapulse, Cooltouch, Coolglide, IPL Fotofacial, Thermage, and Smoothbeam. Cosmetic procedure/surgical consultant. Preparing for and assisting in all surgical procedures. Maintenance and distribution of pharmaceuticals. Preparing patients for and
assisting in all clinical exams, and procedures. Administering injections, recording pathology, preparing prescription forms. Operation and maintenance of a laboratory.
- to -: The Center for Cosmetic Surgery and Dermatology, San Diego, CA
Medical/Surgical Tech.: Maintaining two clinical locations. Scheduling. Cosmetic Consultant. Accounting, filing, and administrative duties. Preparing for and assisting in Mohs surgical procedures as well as all cosmetic surgery: Liposuction, Krypton Laser treatment. Performing chemical facial peels. Recording pathology. Administering injections, preparing prescription forms, operation and maintenance of a laboratory.
- to -: Academic & Aesthetic Dermatology, San Diego, CA
Medical/Surgical Tech.: Preparing for and assisting in Mohs surgery. Cosmetic procedure/surgical consultant. Preparing for and assisting in Liposuction, Blepharplasty, and True Pulse Laser treatments. Preparing prescription forms. Preparing for and assisting in all surgical procedures.Venipuncture. Maintenance and operation of a laboratory. Maintenance and distribution of pharmaceuticals.
- to -: Children’s Healthcare Network, La Jolla, CA (Temporary position)
Medical/Ft. Office Asst.: Multi-phone line system, scheduling appointments. Accounting, filing, and administration. Preparing for and assisting in all back office duties as well.
EDUCATION
Maric College of Medical Careers, San Marcos, CA
Ashworth College, GA - present (AS in Psychology).
CERTIFICATIONS
Certified Medical Assistant
Certified CPR to present
Certified Dermatological Surgical Technician
Certified Mohs Surgical Technician
Certified Cryostat Technician
Certified Mohs Laboratory Technician
Clinical Research Coordinator
CRA/Quality Assurance Monitor
