Skilled and experienced Clinical Research Coordinator, bringing over 20 years of clinical research experience. Strong focus on executing complex protocols, ensuring regulatory compliance and data integrity. Demonstrates meticulous attention to detail in documentation and reporting. Strong organizational skills and thorough knowledge of clinical trial protocols. Specializes in quality control monitoring, budget and contract negotiations and provides in-house monitoring to ensure strict protocol adherence.
Work History
Lead Clinical Research Coordinator
7 Years 4 Months
Centricity Research | 01.2018 - 05.2025
Led clinical trial operations to ensure regulatory compliance and adherence to protocols.
Developed and maintained study timelines, enhancing project efficiency and team coordination.
Trained and mentored junior staff on best practices in clinical research methodologies.
Complied with research protocols by providing ongoing quality control audits.
Prepared and maintained regulatory documents for clinical trial submissions.
Maintained accurate and up-to-date case report forms and source documents for traceability.
Monitored patient safety throughout clinical trials and reported any adverse events.
Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
Managed patient recruitment, informed consent process and data entry to support trial objectives.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Gathered, processed, and shipped lab specimens.
Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Regulatory Specialist; Contract and Budgets, CRC
2 Years
Comprehensive Women's Care | 01.2016 - 01.2018
Ensured compliance with regulatory standards for clinical trials and research studies.
Developed and maintained documentation for regulatory submissions and audits.
Collaborated with cross-functional teams to address regulatory inquiries and issues.
Conducted thorough reviews of protocols, consent forms, and investigator brochures.
Led training sessions on regulatory requirements and best practices for staff.
Negotiated contracts to achieve favorable terms and conditions for stakeholders.
Streamlined negotiation processes, resulting in reduced turnaround times and improved outcomes.
Coordinated clinical trial activities, ensuring compliance with regulatory standards and protocols.
Oversaw data collection processes, maintaining high accuracy and integrity of study data.
Certified Medical Assistant; Contracts and Budgets
1 Year
Central Ohio Orthotic & Prosthetic Center | 01.2015 - 01.2016
Administered patient care and assisted with clinical procedures to enhance patient experience.
Coordinated patient scheduling, ensuring optimal workflow and minimizing wait times.
Maintained accurate patient records in electronic health systems for compliance and efficiency.
Monitored vital signs and documented changes to inform physician assessments and treatment plans.
Assisted physicians with various procedures, ensuring comfort and accuracy for optimal patient outcomes.
Collected and documented patient medical information such as blood pressure and weight.
Taught patients about medications, procedures, and care plan instructions.
Performed diagnostic tests accurately, contributing to swift diagnosis and appropriate treatment options.
Lead Clinical Research Coordinator at The Oncology Institute of Hope and InnovationLead Clinical Research Coordinator at The Oncology Institute of Hope and Innovation