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Click here or scroll down to respond to this candidateCandidate's Name , CCRCFuquay Varina, NC 27526 PHONE NUMBER AVAILABLE EMAIL AVAILABLE LinkedIn ProfileCLINICAL RESEARCH ASSOCIATETrial Management and Execution Research Operations Oversight Patient Recruitment and RetentionEmpowering Clinical Research through Patient-Centric Strategies and Operational Efficiency to Maximize Study Outcomes.Distinguished leader bringing to the table over 2 decades of experience in clinical research and unparalleled success in managing multi-specialty research operations. Renowned for developing and executing research strategies, optimizing trial performance, and ensuring data quality through targeted action plans. Trademark excellence in leading research operations colleagues, managing budgets, and collaborating with leadership, physicians, and practice administrators to bolster patient recruitment, promote staff development, and support investigator-initiated trials for publication. Clinical Research Operations Trial Performance Improvement Data Quality Assessment Lab Management and Assessments ISO 14155 and CFR Title 21 Compliance Study Procedures Execution Budget Development and Management IRB Submissions and Regulatory Compliance Staff Training and Mentoring Patient Scheduling and Correspondence GCP, ICH, and GMP Auditing Standards Cross-functional Team LeadershipCLINICAL RESEARCH EXPERIENCE AND MILESTONESMedtronic, Minneapolis, MN November 2022July 2023Senior Clinical Research Associate Medical Devices (Contract)Served as lead clinical research associate, managing 9+ sites across the US for critical diabetes device study, facilitating optimal site performance and patient safety. Conducted comprehensive site management through extensive travel, coordinating end-to-end operations and upholding the highest patient safety and study integrity standards.Established partnerships with clinical sites, fostering tailored support for patient recruitment, averaging 30-50 patients monthly.Enforced FDA regulations across all studies, promptly identifying safety concerns and reporting findings to Medtronic and institutional review board (IRB).Audited complex study data for accuracy, uncovered discrepancies, and delivered group training to 20-25 staff members, including site coordinators, medical assistants, RNs, and physicians, elevating clinical study skills and performance.Facilitated timely submission of follow-up monitoring reports, including site qualification, initiation, interim, and close-out visits to FDA and sponsor, capturing all corrective actions for short-term studies averaging 17 days each.Participated as the only contractor for the first in-house Type 2 Medical Device Study Start-up for Medtronic employees and tested the new Veeva Vault System to be implemented for this and future studies for all regulatory documents.Trained in LMS for Medical Device.IQVIA, Durham, NC January 2022July 2022Senior Clinical Research Associate Medical Devices (Contract)Managed diverse clinical research projects as central trials conductor, investigator, and patient recruitment specialist, overseeing full project lifecycle from initiation to completion. Coordinated site management and monitoring activities for phase II, III, and IV clinical trials, epitomizing expertise in medical devices, cardiology, and wound care.Partnered with stakeholders, investigators, and clinical operations administrators to keep clinical trials within scope and budget.Oversaw budgets of ~$600K per study, enrolling ~2,000 participants in each trial nationwide; conducted inclusion/exclusions and data analysis for optimal site identification and patient recruitment.Led UK-based Smith and Nephew wound and burn care study, directing study start-up, site monitoring, feasibility studies, and ensuring compliance with EMA, FDA, and ICH regulations.First contractor chosen to work with Smith & Nephew to implement their wound care protocol with the Veeva Vault System.Trained in LMS for Medical Device.Associated Urologist, Raleigh, NC October 2021January 2022Clinical Research Coordinator Data Manager (Contract)Transformed underperforming clinical research operations in urology and cancer studies by providing troubleshooting and advisory support. Associated Urologist, Raleigh, NC October 2021January 2022Clinical Research Coordinator Data Manager (Contract)Increased participation from zero to 15+ patients per study as a trusted advisor and key resource in clinical research operations.Spearheaded implementation of onsite laboratory services, saving each site $200 per patient per visit, and secured buy-in for anonsite radiology clinic, reducing costs by $2500+ per MRI per patient.Identified operational improvements for prostate and bladder cancer studies, leading site to recover $300K in lost revenue.Developed data entry standards to reconcile 500+ queries, yielding monthly recoupment of $20-30K per study.Parexel International, Durham, NC August 2021November 2021Initiation Clinical Research Associate (Contract)Contributed to site start-up, enrollment, and service execution for studies in pediatric cardiology, rare diseases (Ehlers-Danlos syndrome), nephrology, and oncology. Identified 100+ sites, conducted pre-site visits, conducted feasibility assessments, and narrowed prospects to 37 participating locations.Led functional clinical research activities, orchestrating study participant planning and research developments; assessed large data sets, conducted clinical research data analysis, and presented complex reports.Directed regulatory coordination, budgeting, financial analysis, and pediatric research operations; guaranteed high-quality delivery of research in phase II, III, and IV clinical trials through daily processes and procedures.Trained new clinical research staff and advocated for team continuous learning, implementing strategic training program to enhance recruitment, patient onboarding, data entry and analysis, compliance, and ongoing education.Utilized Veeva Vault to house study start-Up activities. Completed Initiation Visits with the Senior CRAs.Calyxo, Inc. (Contract Partner to ConsignMed), Pleasanton, CA November 2020June 2021Senior Clinical Research Associate, Kidney Stone Medical Device (Contract)Partnered with clinical stakeholders in a medical device project, performing site initiation visits, monitoring, and study execution at 6 sites across southeast region. Delivered surgical technique training and proctoring cases at hospitals and surgical care facilities. Maintained compliance with CFR Title 21 CFR Part 803, 812, 814, 50, and 56 and international standards. Design for the Veeva Vault System for the new medical Device Study for kidney stones. Developed SOPs, protocols, 1532s, Financial Disclosures along with new updates for the system.Alliance Urology Durham Nephrology, Greensboro and Durham, NC October 2018February 2020Clinical Research Associate >> Clinical Research ManagerManaged clinical research operations at 8 dialysis centers and a nephrology clinic, supervising team of 3 research coordinators, and overseeing studies in urology and nephrology. Increased study budgets from $27K to $58K per patient and doubled number of trials in six months, while commanding investigator staff of sixteen in nephrology, including hiring, training, annual reviews, and discipline.Sanford Cardiology, Sanford, NC April 2018September 2018Lead Research Coordinator, Interventional Cardiology (Contract)Helmed cardiology studies on stents, MI, cholesterol, and angina, directing patient recruitment, site monitoring, laboratory procedures, and regulatory processes. Performed life-saving CPR on a patient during a study. Maintained 99% patient retention rate.National Intrepid Center of Excellence, Fort Campbell, KY March 2016March 2018Clinical Research Study Manager (Contract)Directed design and execution of a $20M research study on traumatic brain injury with vision and hearing issues in soldiers, subsequently promoted to associate investigator, coordinating neuropsychological and behavioral health assessments. Led team of 70 staff, providing quality management and regulatory/IRB submission support across ten hospital departments. Developed WIIR database to track psychological studies and treatment outcomes for service members.Earlier Career:Lead Data Manager, Diabetes and Cystic Fibrosis (Contract) Quintiles (August 2015February 2016)Drug Safety Specialist I and II (Contract) Pharmaceutical Product Development (February 2015August 2015)Research Project Manager and Analyst (Contract) General Dynamics Information Technology (June 2014February 2015)Clinical Research Coordinator II >> Clinical Research Manager (Full-Time) Novant Health (March 2007June 2014)EDUCATION AND PROFESSIONAL DEVELOPMENTBachelor of Science (BS) in Biology (Minor in Chemistry), Ohio Dominican College, Columbus, OHClinical Research Associate (CRA), Association for Clinical Research Professionals (ACRP)Certified Clinical Research Coordinator (CCRC), University of Southern FloridaGood Clinical Practice (GCP) Certification, Medtronic IRB Regulatory Certificate, Duke HospitalTECHNICAL ACUMENAHLTA Allscripts BioClinica SharePoint LMS CTMS Clinical Conductor ClinPhone/IVRS, Microsoft Office e-ClinicalWorks Electronic Trial Master File(e-TMF) EPIC, HAIMS e-IRB RDC/ EDC LIMS Medidata Rave Clinical Cloud Oracle-Argus RedCAP SIMS VEEVA Vault Long-Boat |
