John Luna

As the Site Manager, I am responsible for the optimization of Site performance and for driving the site to achieve company goals. It is my responsibility to work with Tekton Leaders to problem solve issues that may arise that interfere with achieving company goals. It is important that I represent myself and my site in the most professional, ethical and positive manner.

• Operational Planning - Review and discuss awarded trials with the Principal Investigator to assist Tekton Leaders in making informed decisions about what studies to conduct
• Work with Tekton Leaders to make informed decisions regarding new staff needs for successful study conduct
• Work with Tekton Leaders to ensure the site has proper space, staff and time to optimize study conduct, particularly participant recruitment and retention
• Clinical Operations Management - Work closely with Tekton Leaders regarding staff management
• Demonstrate knowledge of research, company expectations and industry standards
• Lead staff in continued growth and excellent performance
• Hire quality candidates for positions within the site
• Monitor staff performance, holding staff accountable to expectations of roles
• Ensures staff complies with study protocols, FDA regulations, and ICH guidelines
• Ensures staff complies with SOPs and Company policies and processes
• Monitor Site quality and performance and develop solutions to optimize performance
• Monitor study needs and assist staff with study conduct and management as needed
• Manage staff schedules for optimization of site performance by providing feedback to staff
• Work with company leadership to manage discipline, as necessary, HR issues, such as misconduct, violations of company policy or coordinating staff
• Conducted regular site meetings with team members, fostering open communication channels for efficient problem-solving and progress updates.

Alongside the Site Manager, the Clinical Operations Lead functions as a leader and mentor of all clinical research staff. The role focuses on teaching and training staff, ensuring the day to day operations are run effectively and efficiently, and the recruitment goals are met. As the Clinical Operations Lead, I utilized my leadership skills to help Research Coordinators on day to day questions and ensure that staff are trained on current Standard Operating Procedures.

• Works with Site Manager to ensure KPIs are met
• Enhanced team productivity by providing ongoing training and development opportunities.
• Leads team members in study conduct, including study management and task delegation
• Leads team members in work quality and production
• Serves as a leader, mentor, and resource for team
• Assist Site Manager/Director to ensure site is in good working order and staff receive required training
• Monitors study needs and assists staff with study conduct and management
• Assists Site Manager/Director with scheduling of staff and patients
• Ensures coordinator completion of follow-up letter open items prior to the next monitoring visit
• Ensures coordinator preparedness for monitor visits, including completion of source documentation readiness, EDC and query resolution
• Ensures use of latest Informed Consent and use of version check system
• Ensures coordinators are completing regulatory tasks as assigned
• Provides feedback to Site Manager/Director regarding staff workload

• Maintaining the schedule and complying with the study protocol to ensure that subjects understand and most importantly, are comfortable with the dynamics of clinical research
• As the Lead Coordinator for multiple studies, it is my responsibility that staff are properly trained and knowledgeable of the study and its requirements
• Ensuring all visits and procedures are completed as required by the study protocol
• I take pride in maintaining a professional and friendly relationship with the subjects that are participating
• By building a strong relationship with the subject, it establishes care and trust
• Complete Study procedures and assessment with the participant as according to the study protocol
• Coordinate with Investigator, staff and participants that all visits are completed according to study protocol
• Ensure staff delegated to trial are properly trained with current protocols and Informed Consents
• Maintain electronic Investigator Site File that all necessary regulatory documents are properly filed
• Maintain communication between site and study sponsor
• Schedule monitoring visits and ensure all items requested by the study team and completed
• Informed Investigator or protocol related changes and ensure proper training is documented
• Maintain Participant charts
• Enter data into EDC and complete queries in a timely manner
• Review all lab kits for expiration dates and order accordingly

• Converting paper charts to an electronic medical records system
• It was my responsibility for preparing records and documents for their upcoming appointments with their doctors
• Scheduling appointments and answering a multi line phone system for several doctors
• Managed the release of information process, safeguarding sensitive patient data while adhering to legal requirements.
• Implemented quality control measures within the department, resulting in improved accuracy rates in medical record keeping.
• Acted as a liaison between departments, coordinating efforts to achieve efficient interdepartmental communication concerning health information management.
• Enhanced patient care by accurately organizing and maintaining medical records and health information.
• Assisted healthcare providers with timely access to accurate medical records, contributing to better patient outcomes.
• Ensured compliance with HIPAA regulations through diligent management of confidential patient data.
• Optimized storage solutions for physical medical records while ensuring easy retrieval when needed.

• After working as a cashier and stocking items, I was promoted to shift manager. My work ethic and professionalism granted me the opportunity to ensure the store was kept to the utmost manner. I created the schedules for the employees and was responsible for tasks that were assigned to help with function of the store and pharmacy.
• Greeted customers entering store and responded promptly to customer needs.
• Welcomed customers and helped determine their needs.
• Worked flexible schedule and extra shifts to meet business needs.
• Operated cash register for cash, check, and credit card transactions with excellent accuracy levels.
• Restocked and organized merchandise in front lanes.
• Assisted customers with returns, refunds and resolving transaction issues.
• Counted money in cash drawers at beginning and end of shifts to maintain accuracy.