Katlyn Shockley

• Manage daily operations of clinical trials, ensuring efficiency, accuracy, and proactive problem-solving across all stages of the process.
• Monitor active trial participants, assign investigational products through IRT, and ensure compliance with all regulatory and protocol standards.
• Respond to sponsor queries and provide timely updates on trial progress, addressing any concerns or requirements.
• Report AEs/SAEs in full compliance with both protocol and regulatory standards, ensuring patient safety and data integrity.
• Collaborate with sponsor teams to request patient slots, schedule monitoring visits, and maintain consistent trial momentum.
• File protocol deviations per IRB guidelines and provide detailed reports on study deviations or regulatory concerns.
• Assist with regulatory and financial barriers, working with internal teams to resolve issues and maintain trial progression.
• Work closely with the data entry team, ensuring accurate and timely data entry to support overall study integrity and success.
• Develop and implement processes to address potential issues early, reducing protocol deviations and improving workplace efficiency.

• Cultivated and maintained strong relationships with hospital staff to identify and engage potential Principal Investigators for research projects.
• Partnered with the corporate study team to identify and secure potential clinical trials with sponsors, contributing to the expansion of research opportunities.

• Monitored study activities to guarantee adherence to protocols, as well as all relevant local, state, federal, and institutional regulations and policies.
• Screened and consented patients for enrollment in ongoing trials and registries, ensuring eligibility criteria were met.
• Abstracted complex clinical information from multiple sources for research subjects to then record it into various study-specific data-capture systems while ensuring data accuracy.
• Efficiently addressed data queries and conducted routine data management quality control checks.
• Streamlined patient follow-up procedures, increasing staff adherence to study protocols by 50%.
• Collected, processed, and shipped central laboratory blood samples while maintaining strict inventory control over all laboratory kits.

Research Lab Manager Details

• Performed 8-12 required central labs per week. This included approximately 2, 12 hour PK days.
• Developed a streamlined procedure in collaboration with the infusion staff to ensure the following:
• Research patients required only one needle stick per visit.
• Set up four dedicated chairs for trial participants to receive their research drug, with each station fully stocked with spreadsheets specific to pharmacokinetic draws, timers, and spare supplies.
• Ensured all pharmacokinetic draws were performed within the required time window.
• Reduced lab-related deviations by 45% in just six months by enhancing daily processes.

• Delivered outstanding service by assessing customers' needs and recommending products that best matched their preferences.
• Processed purchases and returns while effectively upselling to maximize sales and drive revenue growth.
• Tracked and reported sales activities, consistently meeting store metrics and exceeding district performance expectations.
• Managed opening and closing procedures, including cash register preparation, merchandise stocking, and readiness for upcoming sales.