Karolyn Simpson, RN

Clinical Research Associate II and Registered Nurse with 20+ years of experience across Phase I–II clinical trials, including oncology, metabolic disease, device/IP studies, and early development. Unique hybrid background as CRA, Phase I Coordinator, and Safety Nurse, offering deep expertise in informed consent, AE/SAE assessment, SDV, data integrity, PK/PD-driven protocols, and site management. Known for exceptional documentation accuracy, strong communication, and the ability to work independently across remote and onsite environments.

Highly experienced in audit readiness, risk assessment, and cross-functional collaboration.

Clinical Research Associate II, Phase I Monitoring Services - Fortrea (formerly Labcorp) - Daytona Beach, FL

(2025-12)

• Conduct pre-study, initiation, process, routine, and close-out monitoring visits in accordance with ICH-GCP, SOPs, and sponsor requirements.
• Verify informed consent, protocol adherence, and participant safety across Phase I clinical pharmacology studies.
• Perform SDV, data review, query generation, and resolution to ensure data accuracy and compliance.
• Maintain regulatory documentation, eTMF completeness, and site audit readiness.
• Oversee investigational product accountability and storage compliance.
• Serve as Lead CRA when assigned, supporting project planning and site communication.

CRA II, Early Development - ICON - Blue Bell, PA

(2025-08 - 2025-11)

• Conducted onsite and remote monitoring across early-phase studies, including a long-term investigational product/device study monitored for nearly two years.
• Oversaw device accountability, IP handling, IFU compliance, and procedural documentation.
• Ensured participant protection, protocol adherence, and data integrity.
• Managed essential documents, site communication, and data deliverables.
• Performed risk assessments, site health evaluations, and escalations.
• Supported audit preparation and follow-up activities.

CRA I, Early Development - ICON - Blue Bell, PA

(2023-09 - 2025-08)

• Monitored an investigational product/device study continuously for approximately two years, providing consistent site oversight and maintaining high-quality data throughout the study lifecycle.
• Performed qualification, initiation, monitoring, and close-out visits.
• Verified informed consent and protocol adherence.
• Identified data inconsistencies and escalated risks appropriately.
• Maintained study files and supported query resolution.

CRA II, Oncology - Syneos Health - Charlotte, NC

(2023-05 - 2023-09)

• Monitored oncology trials, ensuring GCP compliance and investigator integrity.
• Managed site performance, documentation, and all visit types.
• Ensured timely data deliverables and protocol adherence.

CRA I, Early Development - ICON - Blue Bell, PA

(2021-11 - 2023-05)

• Conducted onsite and remote monitoring visits.
• Identified inconsistencies in site data and escalated risks.
• Demonstrated strong attention to detail, organization, and communication.

Clinical Study Coordinator III, Phase I Oncology - Florida Cancer Specialists & Research Institute - Sarasota, FL

(2017-04 - 2021-10)

• Coordinated complex Phase I oncology trials, including SAD/MAD, dose-escalation, Food Effect, Drug–Drug Interaction (DDI), and PK/PD-intensive study designs.
• Conducted full-cycle patient coordination from pre-screening through safety follow-up, including protocol-mandated assessments, AE/SAE reporting, and AESI documentation.
• Executed informed consent procedures and ensured compliance with protocol, GCP, and regulatory requirements.
• Performed subject interviews, vitals, ECGs, and clinical assessments required for early-phase oncology protocols.
• Managed investigational product accountability and collaborated closely with Principal Investigators on safety and dosing decisions.
• Supported pre-study visits, SIVs, monitoring visits, and FDA audit preparation.
• Ensured accurate, timely data entry and query resolution for high-complexity oncology studies.

Nurse Team Leader / Safety Nurse (Phase I–IIa) - MDS Pharma → Celerion → Inflamax - Neptune, NJ

(2003-10 - 2017-01)

Continuous employment; same site through corporate transitions

• Supported a wide range of early-phase clinical pharmacology studies, including SAD/MAD, Food Effect, Drug–Drug Interaction (DDI), Bioavailability/Bioequivalence, First-in-Human, and PK/PD profiling.
• Conducted AE assessment, evaluation, reporting, documentation, and follow-up for healthy volunteer and patient-based Phase I–IIa studies.
• Trained nursing and study staff on protocol-required clinical procedures, dosing workflows, and intensive PK sampling schedules.
• Performed protocol and ICF review, SOP development, and query resolution.
• Managed CRC-RN staff and ensured adherence to GCP, protocol requirements, and early-phase operational standards.
• Oversaw complex serial procedures including timed PK draws, ECG collection, vital sign sequences, and device-integrated assessments.

Associate of Applied Science - Nursing - Ocean County College