Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.
Overview
8
8
years of professional experience
Work History
Power BI Specialist
CDC
08.2022 - Current
Clinical Research Associate
ELI LILLY
08.2021 - Current
Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion
Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance
Implemented electronic data capturing systems to adhere with clinical research guidelines
Followed drug storage procedures to comply with protocols and SOP requirements
Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance
Conducted clinical trial in accordance with protocol and recorded and monitored progress
Oversaw project developments to provide quality deliverables while maintaining optimal efficiency
Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations
Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency
Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies
Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity
Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results
Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
Research Associate
Northwell Health Hospital
03.2016 - Current
Gathered, arranged and corrected research data to create representative graphs and charts highlighting results for presentations
Validated incoming data to check information accuracy and integrity while independently locating and correcting concerns
Helped team meet regulatory requirements by coordinating documentation and filings
Set up equipment, organized inventory and maintained facilities
Supported design and implementation of survey instruments such as telephone questionnaires to obtain study information
Evaluated potential subject participants to assess suitability for planned studies
Conducted four studies on prostate cancer and role of each in drug development
Used EDC to determine data-set correlations while initiating qualitative functions
Collaborated with team members to initiate best practices to achieve organizational goals.