Research Coordinator Clinical

KATIE RILEY

Fort Myers, FL

Cell Phone: 954-***-**** LinkedIn www.linkedin.com/in/katie-riley Email: *********@*****.***

CLINICAL RESEARCH COORDINATOR

Dedicated and experienced Research Coordinator with a strong commitment to Good Clinical Practice (GCP) principles. Proficient in-patient recruitment, protocol management, laboratory oversight, and study completion management. Passionate about ensuring comprehensive adherence to research protocols from site initiation to closeout.

CORE COMPETENCIES

GCP Certification

Electronic Data Capture

Microsoft Outlook and Excel Efficient

Regulatory Reporting

ALCOA Documentation

Critical Thinking

Data Analysis

IRB Reporting/Documentation

Investigational Product Accountability

Medical Device Inventory

IATA Certified

Detail Oriented

High Volume Enrollment

EDUCATION

Bachelor of Arts & Sciences in Integrated Studies

Public Health, Florida Gulf Coast University Fort Myers, FL

PROFESSIONAL EXPERIENCE

Alliance for Multispecialty Research, Fort Myers, FL June 2021– Current

Clinical Research Coordinator (January 2023 to Current)

Clinical Research Coordinator Assistant (June 2021 - December 2022)

Ensure adherence to GCP guidelines for on-site and virtual patient visits across 10-12 active Phase II-IV trials.

Proficient in various EDC, IRT, IWRS, and laboratory systems.

Led initiative to redesign shipping and tracking system, enhancing efficiency for over 250 patients and 12 studies.

Collaborate with stakeholders to establish effective communication channels for clinical trial patients.

Communicate study goals and compliance importance to patients during pre-screening and screening visits.

Review medical records and medications for inclusion/exclusion criteria adherence.

Manage and report Serious Adverse Events within 24 hours, ensuring proper documentation and follow-up.

Assist regulatory team in protocol deviation documentation and IRB reporting.

Quality Assurance Specialist (January 2022 - December 2022)

Review source documentation versus CRFs for up to 12 active studies.

Coordinate CRA visits and facilitate communication with stakeholders.

Conduct SOP reviews and recommend revisions as needed.

Manage Site Operational Procedures and regulatory tasks.

VOLUNTEER EXPERIENCE

Kappa Delta Sorority President November 2019 - November 2020

Led chapter operations for 120 members, overseeing philanthropy events and financial affairs.

Managed executive council and maintained communication with Nationals.

Represented the sorority at university meetings and facilitated workshops on diversity and inclusion.

SKILLS

Microsoft Office Suite: Word, Excel, PowerPoint, and Outlook

Data Analysis: Familiarity with data analysis tools including, Microsoft Excel (including formulas, functions, and pivot tables), and Google Sheets

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