Anesa Sakalas
Orlando
Summary
Results-driven clinical research professional with 3.5 years of experience supporting predominantly in person phase I-IV trials across diverse therapeutic areas, with additional experience in decentralized study models. Demonstrates strong expertise in project management, team leadership and cross function collaboration along with a strong patient care focus, and a reputation for being detail oriented, organized and adaptable in various environments. Recognized for clear communication, accountability, and consistent execution that supports high-quality study outcomes.
Overview
1
1
Certification
5
5
years of professional experience
Work History
Senior Clinical Research Coordinator
Transformative Pharmaceutical Solutions
Kissimmee
12.2024 - Current
- Manages and oversees the day-to-day operations in the administration and clinical aspects of clinical trial activities at the site-level.
- Regularly interfaces with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocol.
- Functions as participants’ primary point of contact, keeping them informed on the study progress, and facilitates involvement of other study team members, as needed (e.g., notifies Principal Investigator of safety events).
- Exceeded enrollment targets by directly recruiting 95% of currently enrolled subjects for a study.
- Trained clinical trial staff, ensuring compliance with operational requirements of the clinical trial.
- Provides accurate and timely data collection, documentation, entry, and reporting in both Sponsor and Walgreens databases.
- Disburses investigational product, manages inventory of equipment and study supplies, and provides patient education regarding administration, as necessary.
- Managed eISF oversight and IRB submissions (protocol deviations).
- Engaged local doctors’ offices and health fairs, enhancing awareness and recruitment for clinical trials.
- Assisted in electronic source build out, assuring source documentation matched with protocol and CRF guidelines.
Clinical Research Coordinator
Accel Research Sites- Nona Pediatric Center
Orlando
07.2023 - 12.2024
- Implemented Phase I-IV investigational product studies for both CNS and medical conditions in pediatric and adult populations, sponsored by major pharmaceutical companies.
- Managed 14 independent studies from site initiation visit to study close-out, ensuring compliance with protocols.
- Coordinated monitoring visits with pharmaceutical representatives and CROs, facilitating effective study oversight.
- Conducted pre-site selection, site initiation, monitoring, and close-out visits to ensure smooth study progression.
- Ensured compliance with study protocols, ethical standards, and regulatory requirements throughout the research process.
- Maintained accurate research records, including CRFs and drug dispensation records, ensuring adherence to FDA regulatory standards.
- Trained new staff on protocols and procedures, enhancing compliance and operational efficiency.
- Utilized various EDC and IVRS/IWRS systems to manage study data efficiently and accurately.
- Served as unblinded staff in vaccine studies supporting sister sites.
- Performed lab procedures in accordance with protocol, including blood specimen collection, centrifuge operation, specimen storage and shipping, and accountability tracking.
- Obtained vital signs and performed electrocardiograms (ECGs) as part of patient monitoring.
- Administered questionnaires and monitored study participants to ensure adherence to study protocols and guidelines.
- Ensured that all necessary study equipment and supplies were available, in-stock, and in proper working condition.
Medical Assistant
Nona Pediatric Center
Orlando
08.2022 - 12.2023
- Managed patient care tasks, including taking vital signs, recording medical histories, administering injections, and conducting tests per doctor's protocols to support effective treatment.
- Performed administrative duties, maintaining medical records, processing lab and order requisitions, and scheduling appointments to streamline patient care workflow.
- Ensured cleanliness and sanitation of facility, medical equipment, and examination rooms to uphold health standards and patient safety.
Research Assistant
Accel Research Sites- Nona Pediatric Center
Orlando
10.2022 - 07.2023
- Coordinated study activities for trial participants with the Clinical Research (CR) team, ensuring proper completion of informed consent process.
- Identified potential study volunteers by reviewing medical records and study charts.
- Maintained accurate study charts to reflect current patient status.
- Updated team on incoming data and patient status, including adverse events and discrepancies.
- Ensured the accurate and timely submission of data forms and related materials.
- Assisted CRCs with data entry into electronic case report forms (eCRFs).
- Assisted the CR team in preparing for sponsor audits.
- Provided administrative support to staff by performing tasks such as copying, scanning, filing, mailing, and emailing.
Front Desk Receptionist
Advent Health Imaging Center Lake Nona
Orlando
09.2021 - 10.2022
- Verified pre-certification and insurance coverage for all exams to facilitate smooth patient procedures.
- Handled “release of information” requests for patients, referring offices, other medical facilities, attorneys & insurance companies.
- Verified physician order for procedure, diagnosis and exam specifics matched the exam that was performed.
- Ensured that the referring physician on the order matched what was in the RIS system, if not updated this accordingly within workflow, appointment and demographics.
- Reviewed patient history forms, checklists, and consent forms for thoroughness before submission to technologist.
Education
Bachelor of Science - Biology
University of Central Florida
Orlando, FLAssociate of Arts - General Studies
Valencia State College
Orlando, FLSkills
- Protocol Adherence
- GCP
- SOP Compliance
- Data Integrity
- Data Accuracy
- Laboratory Procedures
- Patient recruitment and Retention
- Inventory Management
- Strong verbal and written communication
- Team Collaboration
- Regulatory Compliance
Certification
- National Phlebotomy Certification, National Registry of Allied Health Professionals, 05/27/27
- Basic Life Support, NationalCPRFoundation, 04/23/27
- IATA Certificate, Mayo Clinic Laboratories, 11/01/26
- GCP certificate, CITI, 01/03/28
- C-SSRS Training Certificate, Research Foundation for Mental-Hyigene-RFMH, 11/01/26
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
- Basic Introduction to Biosafety
- Biomedical (Biomed) Comprehensive
- Biological Responsible Conduct of Research
- Clinical Research: An Introduction
- CRC Foundations
- Dual Use Research of Concern (DURC)
- OSHA Bloodborne Pathogens
- Researchers – Information Privacy & Security (IPS)
- Shipping and Transport of Regulated Biological Materials
Clinical Research Therapeutic Areas
- Dermatology: Atopic Dermatitis (Pediatric and Adults)
- Central Nervous System: Autism (Pediatrics)
- Device: COVID-19/Flu/RSV diagnostic test
- Vaccine: Pediatric RSV, Pediatric/Adult COVID-19, Noro virus, Adult Flu, Pediatric Meningitis
- Infectious Disease: COVID-19 Prevention, COVID-19 Vaccine (Observational study)
- Endocrine: Diabetic Neuropathy Pain (Type II Diabetes), Diabetes
- Gastrointestinal: Colorectal Cancer Screening (decentralized trial)
- Cardiovascular: Prevention
- Obesity: Injection
Timeline
Senior Clinical Research Coordinator
Transformative Pharmaceutical Solutions
12.2024 - Current
Clinical Research Coordinator
Accel Research Sites- Nona Pediatric Center
07.2023 - 12.2024
Research Assistant
Accel Research Sites- Nona Pediatric Center
10.2022 - 07.2023
Medical Assistant
Nona Pediatric Center
08.2022 - 12.2023
Front Desk Receptionist
Advent Health Imaging Center Lake Nona
09.2021 - 10.2022
Bachelor of Science - Biology
University of Central Florida
Associate of Arts - General Studies
Valencia State College