Led site operations to ensure compliance with clinical trial protocols and regulatory standards.
Developed and implemented strategic initiatives to enhance patient recruitment and retention efforts.
Managed cross-functional teams to streamline workflow processes, improving overall site efficiency.
Oversaw budget management, ensuring effective allocation of resources across multiple projects.
Mentored junior staff, fostering professional development and enhancing team performance.
Established strong relationships with research monitors and other research staff, facilitating effective communication and collaboration.
Analyzed site performance metrics to identify areas for improvement and drive operational excellence.
Spearheaded quality assurance programs to maintain high standards in clinical research activities.
Managed a team of professionals, ensuring high-quality performance and adherence to company standards.
Maintained compliance with regulatory requirements while continuously seeking opportunities for process improvement based on best practices.
Provided leadership and guidance to staff through ongoing training initiatives, boosting employee retention rates.
Developed strategic plans for site growth, resulting in increased revenue and profitability.
Successfully managed several projects from inception through completion demonstrating strong project management skills.
Recruited and hired top-quality staff to fill important positions.
Implemented best practices and safe operating procedures.
Trained new team members on site policies and procedures.
Clinical Research Coordinator
Pharmasite Research
Pikesville, MD
04.2017 - 06.2018
Coordinated regulatory submissions and ensured compliance with FDA guidelines.
Developed and maintained project timelines, monitoring milestones for clinical trials.
Led training sessions for new staff on protocols and best practices in trial management.
Streamlined data collection processes, enhancing accuracy of patient records and trial outcomes.
Implemented quality control measures to uphold integrity of clinical data and participant safety.
Fostered relationships with study participants, ensuring adherence to study protocols and retention goals.
Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Gathered, processed, and shipped lab specimens.
Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
Followed informed consent processes and maintained records.
Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
Maintained compliance with protocols covering patient care and clinical trial operations.
Managed patient recruitment, informed consent process and data entry to support trial objectives.
Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
Developed and maintained accurate and up-to-date case report forms and source documents.
Prepared and maintained regulatory documents for clinical trial submissions.
Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.