DIANA TONEY
Deltona,FL
Summary
As a site manager with 4 years of experience in research industry, I bring a proven track record of driving operational excellence, fostering team collaboration, and meeting performance targets. With a strategic mindset and a commitment to delivering exceptional results, I am equipped to lead as a site director, driving growth, optimizing processes, and ensuring unparalleled customer satisfaction.
Overview
19
19
years of professional experience
Work History
Site Manager/CRC
Accel Research Sites
11.2020 - Current
- Reviewed patient records, databases and physician referrals to identify and recruit prospective candidates for research studies.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Participated in site initiation visits and investigator meetings, implementing trials in accordance with study timelines.
- Worked with principal investigator, Sub-I sponsors/CRO’s to facilitate daily study activities and comply with research protocols.
- Performed duties in accordance with all applicable standards, policies and regulatory guidelines when reporting to IRB.
- Followed and obtained informed consent processes and maintained records.
- Screen patients for clinical trials participant's visits and provide monitoring
- Perform phlebotomy, ECG, obtain vital signs, EKG's, labs - lab processing a plus
- Data recording/EDC entry/ Query resolution
- Interview patients for any problems, adverse events, and questions they might have
- Adhere to each protocol's visit schedule/ schedule of assessments
- Perform quality control review of all necessary study documents
- Maintain needed supplies for each assigned study
- Ensured compliance with local regulations, obtaining necessary permits and coordinating inspections throughout the construction process.
- Coordinated training programs for new hires, ensuring all team members were knowledgeable about company policies, safety practices, and job-specific skills.
- Evaluated performance metrics to identify areas for improvement in both individual employee performance and overall project management strategies.
- Established clear lines of communication among various departments involved in the construction process to ensure seamless collaboration toward shared objectives.
- Oversaw all daily office operations and equipment maintenance.
- Collaborate with the site investigators to development optimize clinical research, related strategies and tools.
- Supervise clinical research coordinators and manage the activity of site staff under direct supervision.
- Adhere to standard operating procedures, good clinical practice, and FDA regulations.
- Maintain and report key performance metrics to support operational excellence, and business development.
- Interact with sponsor representatives as necessary and meetings, such as pre-study visits and site, initiation visits, and monitoring visits.
- Actively maintain knowledge of current medical research and trends.
- Responsible for the implementation, oversight, and management of specific programs.
- Oversee development, build the team on site, conducting team meetings, professional training, and performance review.
Emergency Medical Technician
SeaWorld Parks & Entertainment
09.2020 - 04.2021
- Evaluated patient vital signs and status to determine care needs using pulse oximeters and electronic vital sign machines.
- Developed and maintained rapport with coworkers and local hospital staff to facilitate efficient patient care.
- Communicated with lucid patients to gather incident and medical history information.
- Used Equipment to administer treatments in emergent situations with accuracy, safety and speed.
- Administered emergency medication to patients, quickly responding to changes in conditions and medication reactions.
- Administered tests and medication to stabilize patients in field or in transit.
- Conducted equipment and vehicle checks to maintain continuous and safe operation.
Emergency Department Technician
Halifax Health
01.2020 - 09.2020
- Evaluated patient vital signs and status to determine care needs
- Communicated with lucid patients to gather incident and medical history information
- Developed and maintained rapport with coworkers and local hospital staff to facilitate efficient patient care
- Evaluated patient care needs, prioritized treatment, and maintained patient flow
- Ensured safety and well-being of patients
- Performed EKG's and Glucose monitoring
- Answered unit calls and took messages for healthcare staff to maximize team productivity
- Documented updates to patient information in medical charts while maintaining HIPAA compliance protecting confidentiality of records
- Charted vital signs and added telemetry strips to charts
- Promptly received and forwarded incoming communications, such as phone calls, emails and letters, to appropriate staff
Certified Medical Assistant/Office Manager
Michael P Desouza MD
01.2009 - 11.2019
- Hired, managed, developed and trained staff, established and monitored goals, conducted performance reviews and administered salaries for staff.
- Tracked and recorded expenses and reconciled accounts to maintain accurate, current and compliant financial records.
- Oversaw office inventory activities, including ordering and requisitions, stocking and shipment receiving.
- Liaised with patients and addressed inquiries, appointment requests and billing questions.
- Compared vendor prices to ensure optimal savings.
- Optimized organizational systems for payment collections, AP/AR, deposits and recordkeeping.
- Coordinated and maintained impressive office organization to keep facilities efficient, organized and professional.
Certified Medical Assistant
Michael P Desouza MD
06.2005 - 01.2009
- Assisted with routine checks and diagnostic testing by collecting and processing specimens.
- Collected and documented patient medical information such as blood pressure and weight.
- Promoted office efficiency, coordinating charts, completing insurance forms and helping patients with diverse needs.
- Taught patients about medications, procedures and care plan instructions
- Called and faxed pharmacies to submit prescriptions and refills.
- Kept medical supplies in sufficient stock by monitoring levels and submitting replenishment orders before depleted.
- Updated inventory, expiration and vaccine logs to maintain current tracking documentation.
- Prepared blood, urine, stool and sputum lab specimens for diagnostic evaluation.
Education
Certificate - Medical Assisting
Daytona State College
Daytona Beach, FL06.2005
EMT Certificate -
Daytona State College
Daytona Beach, FL12.2018
A.S. Certificate Paramedic - Paramedic
Daytona State College
Daytona Beach, FL08.2020
A.S. Degree in EMS - Emergency Medical Services
Daytona State College
Daytona Beach, FL08.2020
Skills
- BLS Provider (AHA) 09/09/2022-09/2024
- ACLS Provider (AHA) 02/03/2024-02/03/2026
- PALS Provider (AHA) 02/03/2024-02/03/2026
- Insurance claims
- Medical procedure knowledge
- Insurance carrier knowledge
- EMR
- Able to lift up to 50 pounds
- Medical billing and coding
- NAEMT Prehospital Trauma Life Support 11/01/2023
- Highly motivated Committed Team Player
- Assisting with physical exams
- HIPAA compliance
- Medical terminology knowledge
- Good Clinical Practices 2026
- Informed consent
- Research SOPs understanding
- Study protocols
- Medication dispensing
- Specimen collections
- Schedule Coordination
- Active Listening
- Data Entry
- Good Telephone Etiquette
- Attention to Detail
- Multitasking Abilities
- Dependable and Responsible
Additional Information
A phase 3 Randomized Stratified observer blind placebo controlled study to evaluate the efficacy, safety, and immunogenicity of mRNA-1273 Sars-COV-2 vaccine in adults aged 18 and older- Lead CRC 2020-present
A randomized double-blind placebo controlled phase 3 efficacy study of an Ad26.RSV.preF based vaccine in the prevention of lower respiratory tract disease caused by RSV in adults age 60 years and older-Lead CRC 2021-present
A phase 3 safety, immunogenicity, and lot consistency trial of the VLP-based Chikungunya vaccine PXVX0317 and healthy adults and adolescence - Lead CRC 2021-present
Phase 3, Multi Center, randomized, double-blind group sequential, placebo controlled study to assess efficacy and safety of rimegepant for the treatment of migraines (with or without aura) in children and adolescents 6 to 18 years old. Lead CRC 2021-present
A phase 3 randomized observer blinded placebo control studies evaluate efficacy safety and immunogenicity of Sars-Cov-2 recombinant spike protein nanoparticle vaccine (SARS-Cov-2 rS) with Matrix-MI adjuvant in adult participants over the age of 18 years old with a pediatric expansion and adolescence 12 to 18 years of age. CO-Lead 2021-present
A second multi center double blind randomize Placebo controlled face retry evaluating the efficacy and safety of Cytisinicline in adult smokers. CO-Lead 2022-present
An Open-label multicenter extension study to characterize a long-term safety and efficacy of BMS-986165 and subjects with modern to severe plaque psoriasis. Lead CRC 2020-present
Phase 1 double blind randomize crossover study and older healthy subject to compare the safety tolerability and pharmacokinetics of LYT -100 (Deupirfenidone) to Pirfenidone CO-Lead 2021.
A phase 1 study to assess the pharmacokinetics of different multiple dose regimens of CT1812 and older healthy volunteers CO-Lead 2022-present
FEMA Certificate IS-00100C
FEMA Certificate IS-00700B
FEMA Certificate IS-00200B
FEMA Certificate IS-00800C
Timeline
Site Manager/CRC
Accel Research Sites
11.2020 - Current
Emergency Medical Technician
SeaWorld Parks & Entertainment
09.2020 - 04.2021
Emergency Department Technician
Halifax Health
01.2020 - 09.2020
Certified Medical Assistant/Office Manager
Michael P Desouza MD
01.2009 - 11.2019
Certified Medical Assistant
Michael P Desouza MD
06.2005 - 01.2009
Certificate - Medical Assisting
Daytona State College
EMT Certificate -
Daytona State College
A.S. Certificate Paramedic - Paramedic
Daytona State College
A.S. Degree in EMS - Emergency Medical Services
Daytona State College