Clinical Research Virtual Assistant
Resume:
Maria Patricia Camacho
Ocala Fl. *****
***.******@*****.***
Summary
Experience as a Clinical Research Coordinator professional with 10 years in the industry, seeking an opportunity in Clinical Research. Proficient in ICH GCP guidance and query resolution and experienced in developing subject recruitment plans and conducting initiation, monitoring, and close-out visits.
Highlights
Experience in Ethics in Clinical Research, Reporting & Documentation.
Assisted Trial Monitoring, Start-Up, Site Initiation, Study Close-Out visits.
Skilled in Vaccines, Gen Med, Neuro Alzheimer's, NASH, and Devices studies.
Experience in Phase I, II, and III Neurological Disorders, Epilepsy, Parkinson's Disease, and Weight Management studies.
Proficient knowledge of Microsoft® Office; Strong communication and presentation skills; and detail-oriented and efficient in time management.
Great understanding of FDA regulations and DOA and Greenlight Process.
Education
Master of Science in Nursing - Specialization in Public Health
Aspen University - Phoenix, AZ June 2023 to present
Bachelor of Science in Nursing
Aspen University - Phoenix, AZ May 2019 to January 2021
Professional Experience
Charter Research The Villages, Fl.
Lead Clinical Research Coordinator July 2023 – May 2024
Communicate with the medical site staff, including coordinators, clinical research physicians, and site staff.
Ensure good documentation practices are adhered to and appropriately communicate protocol deviations per SOPs, GCP, and applicable regulatory requirements.
Regulatory document review; Medical device and/or investigational product/drug accountability and inventory
Good understanding of the Start-Up study, SAEs reporting, and Randomization process.
Supported the Principal Investigator, CRA, and Coordinators in protecting the rights and welfare of all human research participants involved in research in conformity with federal regulations.
Experienced in QC chart monitoring, query resolutions, CRIO, and EDC, maintaining 100% accuracy.
Accelerated Enrollment Solutions The Villages, Fl.
Lead Clinical Research Coordinator January 2022 to July 2023
Developed, coordinated, and implemented research and monitoring strategies essential to managing clinical trials and query resolution.
Involved in all aspects of research, including patient screening consent, assessing eligibility, randomization, and coordinating care.
Maintained HIPAA-protected database connecting patient information to biospecimen used in research; performed patient chart review and data collection.
Clinical experience performing procedures such as vitals and EKGs.
University of Florida Hospital Gainesville, Fl.
Certified Surgical Technologist May 2020 to October 2021
Worked closely with the Neuro-surgery Faculty on clinical research studies involving genetic testing and surgical procedures for patients with Epilepsy.
Assisted Clinical Research Deep Brain Stimulation (DBS) placement and device research studies for Parkinson's disease, essential tremor, and dystonia.
Assisted neurosurgeons during brain surgery research procedures, including craniotomies, aneurysm clipping, and electro-placement for research studies.
License and Certification
Puerto Rico - Registered Nurse License
Human Rights Consultant Certification
Languages
English & Spanish - Writing/Reading/Speaking
Technology and Skills
Knowledgeable of Microsoft Office and the ability to learn appropriate software.
Experience GCP / Documentation and QCs reviews, Team Building and staff training, and AEs/ SAEs reporting.
Demonstrated ability to attain knowledge of GCPs and applicable SOPs.
Excellent interpersonal skills, including establishing relationships with customers, vendors, peers, and stakeholders.
References Available upon Request
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