Amber Enoch
Cary,NC
Summary
Detail-oriented Clinical Research Professional with a strong foundation in healthcare and 16 years of experience supporting study start up, clinical trials, data collection, and regulatory compliance. Effective problem-solving and organizational skills which result in efficient time management, completion of projects, and positive outcomes in patient care. Responsible for following GCP and FDA guidelines from study start up to close out. Adept at collaborating with cross-functional teams to ensure quality data and successful trial outcomes. Ability to develop and maintain positive relationships with other health care professionals and team members.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Clinical Systems Project Associate
Worldwide Clinical Trials
Durham, NC
06.2021 - Current
- Collaborates with project managers on developing and supporting clinical systems and studies
- Executes activation of sites and generated manual shipments in both Medidata RTSM and Merative systems
- Manually assigns drugs to subjects when requested from the study team
- Draft and update support documents, study instructions, and manuals as necessary.
- Diagnose, record and resolve system failures
- Document and archive all activities in alignment with relevant SOP and client company requirements
- Facilitate study start-up while delivering information to study team regarding new studies
- Coordinate drug supply management and troubleshoot related issues while advising project managers of current support matters
- Manage user access within Veeva, Suvoda, Y-Prime, TMF, Zelta, Opra, and Medidata systems
- Onboarding of new team members
- Serve as main support liaison for GPL’s, PM’s, and CTM’s addressing access-related inquiries and site-specific questions.
- Perform access reviews across multiple systems.
- Effectively oversee helpdesk operations for EDC and IRT requests, ensuring timely SLA compliance.
Clinical Assistant/Patient Care Coordinator
Raleigh Neurosurgical/Midtown Pain & Spine
Raleigh, NC
04.2019 - 05.2021
- Strong knowledge of medications and drug interactions relative to pain management and understanding diverse orthopedic and neurological diagnoses
- Ensured strict confidentiality of patient information, consistently following HIPAA guidelines.
- Processed and submitted prior authorizations for medications through patient insurance, supporting need for prescribed treatments
- Demonstrated proficiency in EPIC EMR system for effective patient information handling.
Timely creation and documentation of new patient chart notes facilitated physician sign-off.
Radiology Operations Assistant
Novant Health- MRI
Raleigh/Durham, NC
05.2016 - 04.2019
- Proficient knowledge of medical terminology necessary for evaluating patients' conditions during MRI procedures
- Assist patients in achieving safe and effective preparation for MRI screening
- Coordinated arrangement of patient tables, coils, and necessary equipment for MRI procedures
- Supported radiology technologists in preparing patients for MRI procedures, ensuring safety and comfort during processes
- Navigated multiple diagnostic imaging centers in the triangle area, delivering exceptional patient care services across a broad population
Education
Healthcare Clinical Research Course -
Wake Tech Community College
01.2024
Doctor of Physical Therapy -
Nova Southeastern University
Bachelor of Science Degree; Physical Therapy -
Florida A&M University
Skills
- Leadership & Development
- Process Improvement
- Relationship Building
- Customer Engagement
- Effective Decision-Making
- Drug supply management
- Prior Authorization
- EPIC documentation
- Regulatory compliance
- Good Clinical Practice
Certification
- Certified Personal Trainer, National Academy of Sports Medicine (NASM), 2009
- Certified Nursing Assistant
References
References available upon request.
Timeline
Clinical Systems Project Associate
Worldwide Clinical Trials
06.2021 - Current
Clinical Assistant/Patient Care Coordinator
Raleigh Neurosurgical/Midtown Pain & Spine
04.2019 - 05.2021
Radiology Operations Assistant
Novant Health- MRI
05.2016 - 04.2019
Healthcare Clinical Research Course -
Wake Tech Community College
Doctor of Physical Therapy -
Nova Southeastern University
Bachelor of Science Degree; Physical Therapy -
Florida A&M University
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