Proficient in current Clinical Research regulations, standards and best practices. Analytical and detail oriented professional focused on making sure the regulatory team is supported at all times. Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities.
Overview
3
3
years of professional experience
Work History
Regulatory Assistant
Centricity Research
99 N. Brice Road, Suite 260, Columbus, OH 43213
07.2022 - Current
Assist in the preparation and submission of regulatory documents to ethics committees, regulatory authorities, and institutional review boards (IRBs)
Compile and organize essential study documentation, including investigator brochures, informed consent forms, and study protocols
Maintain an organized and up-to-date filing system for all regulatory documents, ensuring easy access for audits and inspections.
Track and manage version control of study-related documents and informed consent forms
Liaise with principal investigators, clinical research coordinators, and regulatory agencies to facilitate communication and compliance
Coordinate with study sponsors and contract research organizations (CROs) to exchange regulatory information and documentation
Participate in training sessions related to regulatory compliance and stay updated on industry regulations and guidelines
Maintain training records and documentation for all staff involved in the clinical research
Receptionist
Columbus Springs East Hospital
2085 Citygate Dr, Columbus, OH 43219
03.2022 - 07.2022
Demonstrated excellent customer service when greeting guests and receiving calls
Performed wide variety of clerical duties such as typing, filing, copying, message taking, and faxing
Followed information through while adhering to HIPAA guidelines
Work closely with Business Development and Intake departments in the patient assessment and admission process
Handled successfully 50+ phone calls daily with no complaints and redirected calls to the right department
Greeted and welcomed clients and visitors and create a positive first impression of the company
Maintained electronic charts using EMR software
Checked patients in before the assessment and admission process
Psychiatric Care Technician
The Ohio State Wexner Medical Center
410 W 10th Ave, Columbus, OH 43210
06.2021 - 02.2022
Treated clients and families with respect and dignity
Charted on each patient daily
Took and monitored vital signs, administered medications, and managed patient behavior
Assists in maintaining therapeutic milieu in compliance with hospital and regulatory agency standard
Technical skills include recording and transmitting EKGs, specimen collection, phlebotomy skills, Accucheck, applying therapeutic holds and restraint in physical crisis situations, operating specialty beds, assistive equipment, and mechanical lifts and scales
Excellent documentation and reporting skills in Epic along with the ability to maintain confidentiality and accuracy of patients' medical records
Performed one on one patient care with diverse populations in crisis situations
Patient Care Assistant
Columbus Springs Dublin Hospital
7625 Hospital Dr, Dublin, OH 43016
06.2020 - 06.2021
Attended to patient and family's immediate needs and concerns by acknowledging and providing required attention.
Recorded temperature, blood pressure, pulse, or respiration rate as directed by medical or nursing staff.
Answered call lights and supported patient comfort and safety by adjusting bed rails and equipment.
Monitored and maintained cleanliness, sanitation, and organization of assigned station and service areas.
Effective verbal and written communication skills and the ability to develop good relations with patients and provide emotional support
Strong organizational and time-management skills to cope with critical situations