Dejoix-Leigh King
Atlanta,GA
Summary
Accomplished Clinical Research Associate with 4 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
Childrens Healthcare Of Atlanta
10.2021 - Current
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
- Hired and trained over 10 research subjects and monitored progress, answered questions and provided guidance during course of clinical study.
- Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
- Created and maintained database and records filing system to document data on specimen collection, processing and storage.
- Supported development and delivery of department training to maximize success of clinical research.
Leukemia & Lymphoma Clinical Research Coordinator
Children’s Healthcare of Atlanta
10.2021 - 10.2022
- Oversees clinical trial administration for all protocol phases for Leukemia and Lymphoma Disease clinical research department
- Conducts monitor visits such as site initiation visit, interim visit and close out visits
- Serves as resource for study team members and principal investigators and assists with subject recruitment, data collection, scheduling of study-related activities and follow-up with enrolled subjects
- Works with faculty in development of investigator-initiated studies
- Assist in quality assurance and control of data resulting from studies
- Develops procedures related to clinical trial coordination
- Manages submission of regulatory documents in accordance with IRB, federal, industry, and institutional guidelines and requirements
- Monitors site activities and ensures adherence to study protocols and SOPs
- Builds, fosters and maintains relationships with investigators and site staff.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies for approximately 11 studies and 8 sites
Clinical Research Assistant
Children’s Healthcare of Atlanta
03.2021 - 10.2021
- Coordination of regulatory correspondence/documents for 9 research studies
- Independently maintained official regulatory binder for each sponsored clinical trial
- Assisted with research protocol development.
- Educated patients regarding all facets of clinical study participation.
- Demonstrated advanced knowledge of federal regulatory compliance guidelines.
Research Oncology Pharmacy Technician II
Children’s Healthcare of Atlanta
06.2020 - 03.2021
- Prepared medications under direction of pharmacist by measuring, mixing, counting, labeling, and recording amounts and dosages of medications according to prescribed orders
- Worked under supervision of registered pharmacist, prepared intravenous solutions that contained medications that are given to patients in various health care settings.
- Ordered medicines daily to replenish stock and increase inventory in anticipation of need.
- Maintained proper drug storage procedures, registries, and records for controlled drugs.
- Entered and processed patients' prescriptions into internal system.
Education
Bachelor of Science in Health and Community Wellness -
University of West Georgia
Carrolton, GA06.2020
Master of Science in Public Health with Concentration In Epidemiology -
Georgia State University
Atlanta, GA12.2024
Skills
Phases II-IV Clinical Trial
- AE/SAE Reporting
- EDC Management (EPIC, Medidata RAVE, RedCap)
- Source Data Verification
- Subject Enrollment
- Status Reporting
- Good clinical practice
- Team Training
- Integrated medical reporting
- Data Evaluation
- Site monitoring
- Data Collection
- Project Management
- Completing regulatory documents
- Reviewing data standards
- Detailed documentation
Certification
- CITI GCP and ICH
- CITI Training Course
- CITI Human Subject Research
- CITI Conflicts of Interest
- CITI Information Privacy and Security
- IATA certified
- CCRA certification expected October 2024
Affiliations
- Black Women In Clinical Reseach
Timeline
Clinical Research Associate
Childrens Healthcare Of Atlanta
10.2021 - Current
Leukemia & Lymphoma Clinical Research Coordinator
Children’s Healthcare of Atlanta
10.2021 - 10.2022
Clinical Research Assistant
Children’s Healthcare of Atlanta
03.2021 - 10.2021
Research Oncology Pharmacy Technician II
Children’s Healthcare of Atlanta
06.2020 - 03.2021
Bachelor of Science in Health and Community Wellness -
University of West Georgia
Master of Science in Public Health with Concentration In Epidemiology -
Georgia State University
- CITI GCP and ICH
- CITI Training Course
- CITI Human Subject Research
- CITI Conflicts of Interest
- CITI Information Privacy and Security
- IATA certified
- CCRA certification expected October 2024
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