A*****s
About Candidate
I specialize in the ‘engine room’ of clinical research managing the cross functional timelines, quality systems, and regulatory documentation that keep Phase II–IV trials compliant. My background is rooted in Biology and Operations, which allows me to lead teams through complex system changes while maintaining on time delivery. Most recently, I’ve been recognized for improving decision making speed by 40% across departments, and I’m looking to bring that same level of operational efficiency and mentorship
Clinical Research Coordinator professional with 5+ years of experience supporting Phase II–IV clinical trials and operational programs across biotech, pharma, and healthcare. Adept at coordinating project timelines, cross functional teams, quality systems, and regulatory documentation while improving team performance and operational efficiency. Experienced in leading groups of 5 to 20 personnel, mentoring new staff, guiding workflow priorities, and supporting resource allocation. Known for transforming disorganized processes into structured, audit ready systems most notably increasing documentation accuracy by 30%, reducing cycle times by 25%, and improving cross functional decision making speed by 40%. Proven ability to lead teams through system changes, operational shifts, and high volume periods while maintaining quality and on time delivery.
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Education
BS Biology
Work & Experience
Executed high volume phlebotomy and vital sign collection for up to 80 participants daily, ensuring strict adherence to specimen collection protocols and timely processing for diagnostic evaluation. Partnered with clinicians during physical examinations and procedures, maintaining rigorous infection control and safety standards to ensure participant safety and study environment integrity. Maintained 100% data accuracy for 50+ weekly participant records, ensuring full HIPAA compliance and the integrity of source documentation required for potential regulatory audits. Spearheaded daily operations and trained a team of 5 during peak volumes, optimizing workflow efficiency by 20%while maintaining a high standard of care and data precision. Accelerated room turnover by 15% through proactive logistics management; consistently achieved 100% on safety audits (OSHA), demonstrating a commitment to regulatory readiness. Functioned as a Primary Coordinator during staffing shortages, managing complex scheduling and patient flow to prevent disruptions in clinical service and data collection
Led transitions through scheduling and EHR updates. Supported patient enrollment and care by identifying eligible participants, obtaining informed consent, administering assessments, phlebotomy, taking vitals, assisting with exams, and coordinating follow ups. Collaborated with clinicians and program staff through meetings and organized documentation while providing in clinic patient support including appointment reminders, testing prep, and escorting patients. Increased documentation efficiency by 25%; maintained a less than 1% error rate across 50+ daily interactions.
Facilitate the ICF process by clearly explaining study objectives, potential risks, and benefits to participants, ensuring all questions are addressed in compliance with GCP guidelines. Improved monitoring readiness by 20%; accelerated IRB submissions by 15%, under senior CRA supervision Conduct initial patient screenings by reviewing medical histories and laboratory results against specific inclusion/exclusion criteria to ensure participant safety and data integrity Coordinate and lead patient study visits, including the collection of vital signs, performing ECGs, and overseeing the administration of investigational products while maintaining a high standard of patient care. Monitor participant well being throughout the trial lifecycle, documenting and reporting AEs and SAEs to the PI and IRB within required timelines. Serve as the primary liaison between participants and the clinical team, providing ongoing education regarding study protocols and medication adherence to improve participant retention rates.
