As a Clinical Operations Manager at SRA Trials, I oversee the planning, execution, and conduct of clinical research trials, ensuring operational efficiency, regulatory compliance, and team collaboration. My responsibilities include implementing trial plans, managing timelines, budgets, and resource allocation, while optimizing resources and ensuring the facility is fully equipped and functional for study conduct.I oversee the pharmacy, clinical, and laboratory teams, ensuring seamless coordination and adherence to study protocols and operational standards. I ensure strict compliance with ICH/GCP guidelines, FDA standards, and local regulations, while maintaining protocol adherence, site readiness for audits, and regulatory submissions. I address deviations through effective corrective and preventive actions (CAPAs).I prioritize team development by ensuring the pharmacy, clinical, and laboratory teams, including Clinical Research Coordinators, are trained, qualified, and efficient in executing study tasks such as protocol implementation, study drug administration, safety monitoring, and data collection. This guarantees operational and regulatory readiness.Serving as the primary liaison with sponsors, monitors, and internal departments, I ensure alignment, transparency, and effective communication across all stakeholders. I actively contribute to site improvement initiatives, risk management, and the development of SOPs and processes. By providing high-level metrics to site leadership, I support data-driven decisions and actionable insights.This comprehensive approach ensures high-quality study outcomes, optimal facility readiness, and operational excellence across all clinical trial activities.

At the Miami site of Quotient Sciences, with the capacity for 140+ beds and equipped with a variety of specialized equipment to support a wide range of study designs, I was responsible for the planning, oversight, and delivery of the clinical stage for half of the site’s 20 to 30 Phase-One clinical trials conducted annually.Effectively utilizing available resources and space was crucial for meeting study deliverables. I provided operational and regulatory expertise, ensuring maximum clinical operational productivity, adherence to ICH/GCP guidelines, local regulations, and seamless study delivery. Additionally, I took responsibility for my team’s growth and training, ensuring that Research Nurses and Technicians under my supervision were trained and qualified to work on studies as required by regulations and operating procedures. This included protocol training, study drug administration, safety monitoring, data collection, and documentation.I participated in and led crucial meetings for my assigned projects from initiation to completion, working closely with sponsors, monitors, and key Quotient departments. I also supported incident investigations, implementing effective and measurable CAPAs when necessary, and attended meetings focused on site and operational improvements.As a leader, I prioritized accurate communication of study requirements, fostering teamwork, proper delegation, and clarity of tasks. This approach was essential in ensuring that clinical study deadlines and objectives were consistently met.What I enjoyed most about this role was the opportunity to take on tasks and challenges in which I had demonstrated success throughout my career. My experience in development, study management, leadership, systems and document development, and operational contributions allowed me to thrive in the dynamic and ever-evolving world of the pharmaceutical industry and clinical trials.

As the Lead Trainer for Syneos Health, I was responsible for the drafting, creation, conduction, training and compliance of standard operating procedures and regulatory training. This included Good Clinical Practices, study drug administration, informed consent, project delegation, regulatory submission, and all associated technical tasks. I Planned and performed new and on-going training for different site roles and study deliverables. I also functioned as a resource for employees, to ensure internal and protocol specific procedures were followed by providing support with knowledge and facilitation of GxP driven operating procedures.I led functional coaches and delegated training supervision to the different functional areas. Provided monitoring metrics of training progress to site’s Director and functional leaders, to evaluate training development and compliance across departments. I also supported the clinical delivery of floor tasks, and often performed study drug administration, telemetry monitoring, Holter set up and monitoring as well as all technical tasks such as electrocardiogram, IV insertion and vital signs. As a trainer, I would use these tasks to cross-train colleagues.In addition to my former role, I was the Biological Safety officer and Health and Safety officer since 2017, and thus responsible for ensuring that local, state, and federal requirements were met when it refereed to employee’s health and safety. Furthermore, as the onsite Senior Trainer, I was heavily involved in audit interviews, responses, investigations and have been responsible for the presentation of the training program to auditors and regulatory agencies, to demonstrate the site’s qualifications and training capabilities.

As an Independent contractor, American Heart Association and American Red-Cross certified, I was able to provide services, consultation, and training to the Miami area.Provided ad hoc requests that ranged from telemetry monitoring, CPR, OSHA-Blood-borne Pathogens, training, Intravenous drug administration, Intravenous access, amongst other tasks within scope of practice.

This role within the safety team was driven by ensuring the safety of subject-volunteers throughout their study participation.I often provided, and documented, front-line medical support to study volunteers during adverse event and communicated relevant information to the physicians to ensure the overall safety of subject.Performed complex administration of study drugs, maintenance of crash-carts, provided constant vigilance and follow up of adverse reactions and re-consented as needed. Skills applied during this role: • Administration of study drug within scope: IV, IM, SC, PO. • Maintenance of crash cart. • Re-consented volunteers with ICF• Catheter insertion and venipuncture.• Vital signs, electrocardiograms and collect urine samples as per guidelines.

Rapid emergency intervention to life threatening events. Performance of research medical procedures such as drug administration, IV access, Vital Signs, ECG interpretation, blood draws and telemetry monitoring. Constant usage of different advances and basic medical equipment in a safe and accurate manner. Daily documentation of all procedures in an accurate, efficient and timely manner. Daily transfer of events through a detailed and accurate shift report to incoming shift. Daily emergency equipment and drug availability check.

Manage and execute all laboratory procedures including vital signs, phlebotomy, IV placement, ECG’s Holter monitors, ABPM monitoring, Telemetry and Actigraphic placement for adult and pediatric patients. Responsible for Lab processing and packaging of samples. Maintenance and assurance of all site equipment calibration including maintenance and supervision of temperature, humidity and other required logs in the laboratory and drug rooms. Maintenance of Crash Cart and AED. Conduction of patient and caregiver interviews. Family and pharmaceutical sponsor interaction. When assigned, assist Study Coordinator with all facets of the study protocol. When assigned, manage, administer, perform and rate psychometric tests, maintain data and complete caser report record. Dispense medication and monitor drug log inventory, follow-up of adverse events. Communicate and implement direct orders from Principal and/or Sub-Investigator.

Rapid emergency intervention to life threatening events. Performance of research medical procedures such as drug administration, IV access, Vital Signs, ECG interpretation, blood draws and telemetry monitoring. Constant usage of different advances and basic medical equipment in a safe, accurate manner. Daily documentation of all procedures in an accurate, efficient, timely manner. Daily transfer of events through a detailed, accurate shift report to incoming shift. Daily emergency equipment, drug availability check

Aid in emergency, life threatening situations. Performance of medical procedures such as Vital Signs, ECG, and blood draws. Constant patient monitoring. Documentation of procedures in an accurate, efficient and timely manner.