Greater Biloxi Area
An accomplished Clinical Research Associate II specializing in Oncology, Ophthalmology(Glaucoma), Neurology, Psychiatry, Infectious Disease, and Endocrinology. Extensive knowledge of ICH and GCP practices. With the ability and drive to meet deadlines on time, I have extensive knowledge of ICH and GCP practices.
• Plans, conducts, and completes investigations under the supervision of the head of the project. • Participates in data collection and organization, literature reviews, structured interviews, provides basic data analysis and interpretation. • Assists with the preparation of technical reports, summaries, and protocols. • Maintains clear and accurate records, inventories and logbooks. • Verifies and corrects data entry for research projects, supports senior staff in quality control, and provides troubleshooting. • Provides written updates to senior staff. • Evaluated electronic data capturing systems for adherence to guidelines.
• Assisted with management and administration of clinical research projects: recruiting investigators, negotiating budgets, collecting investigator documentation, site management, clinical contact, and preparing status reports. • Identified, initiated, monitored, and closed out clinical investigative sites under supervision from Project Managers and other senior management. • Maintained study and site documents from study initiation through archival process. • Assisted and managed training of new Clinical Research Associates and ancillary staff. • Provided ongoing assistance and education of investigational sites in clinical research. • Updated, tracked and maintained study specific trial management tools/system. • Ensured patient safety, maintenance of ethical treatment and compliance to study protocols. • Ensured compliance with local legal requirements, laws and standards. • Monitored Case Report Forms (CRF/eCRF) for missing and/or implausible data. • Assisted sites with maintaining Good Clinical Practices (GCP). • Assisted with generation and reconciliation of queries to investigation sites to resolve inconsistent, missing, or implausible data. • Created and reviewed reports/narratives and follow-up on reported serious adverse experiences. • Assisted/facilitated legal review of investigator agreements. • Assisted and managed project budget and investigator site budget/payments, attended project team meetings, planned and attended investigator meetings, and communicated with stakeholders, investigators, and key opinion leaders. • Created Standard Operating Procedures and Work Instructions as required. • Generated and tracked drug utilization, shipment, and storage. • Provided coverage to clinical contact telephone lines. • Traveled as necessary, consistent with project needs. • Performed other duties assigned by management.
• Ensured that each potential patient met inclusion criteria for the study and that it was in Patient's best interest to participate in the study. • Thoroughly educated the patient the purpose of study, duration, and what is expected of the patient. • Coordinated appointment scheduling for internal and external appointments; sent patients for biopsy for any study-related procedures. • Administered informed consent to patients. • Took history, drew blood, obtained vital signs, performed EKGs and other tests required for studies. • Closely monitored the patient's health while on study medication and noted each adverse event. • Acted as liaison between patient and study physician. • Prepared specimens for shipment. • Dispensed study medication in the manner prescribed by the protocol. • Kept accurate medication accountability. • Established priorities and made ethically sound decisions to ensure safe patient care. • Maintained patient files, records and other information in a professional manner following policy and procedures regarding documentation.