LORENA D. FARRELL
Morristown,NJ
Summary
Meticulous clinical research coordinator and study specialist passionate about providing expert technical and administrative support to clinical study teams in the execution of complex trials within fast-paced, purpose-driven environments. Accountable leader dedicated to empowering timely start-up and successful delivery of clinical studies across numerous therapeutic areas — principally oncology — who consistently meets aggressive timelines, budget parameters, and rigorous quality and regulatory standards. Accomplished strategist with profound operational knowledge spanning every stage of the study lifecycle and deep understanding of the R&D process, adept at forecasting milestones, driving cross-functional teams, and ensuring impeccable communication and documentation.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Clinical Research Nurse Coordinator
SUMMIT MEDICAL GROUP
01.2022 - Current
- Orchestrate patient enrollment and engagement across 100+ hematology and oncology clinical trials as main point of contact and accountability guiding participants through all phases of research with compassion and clarity. Partner with regulatory coordinators to prepare essential start-up documentation and facilitate thorough audits for ongoing studies. Conduct internal compliance reviews to maintain full U.S Food and Drug Administration (FDA) adherence and implement corrective measures as needed. Train and mentor new associates in regulatory compliance, data management, and protocol execution, fostering operational excellence. Consistently deliver high performance and earn company trust, resulting in sustained retention through multiple restructurings due to consummate expertise and unwavering adaptability.
- Executed 370+ clinical trials — predominantly hematology and oncology with select COVID-19 antibody and dermatology studies — spanning registry through Phase 4, retrospective analyses, and 2 breast cancer device trials; successfully enrolled and monitored 350+ patients through protocol-defined endpoints, demonstrating in-depth expertise across varied trial phases and therapeutic categories.
- Mobilized 124 clinical trials in the past 3 years alone, guiding 258 patients from active interventions through long-term follow-ups; currently managing 20+ open trials with approximately 30 active patients, playing pivotal role in the timely submission of trial results to critical electronic data capture (EDC) systems.
- Facilitated the informed consent process for trial participants, driving superior adherence to protocol requirements and regulatory standards through clear communication and meticulous procedural execution.
- Certified rigorous compliance with study protocols, protecting data integrity while upholding Good Clinical Practice (GCP) guidelines and International Council for Harmonisation (ICH) standards across all trial activities.
- Developed precise, protocol-specific budgets through detailed analysis of site fee schedules and identification of costs tied to required procedures and activities, skillfully balancing financial stewardship with the pursuit of optimal patient outcomes as well as sustainable clinical operations.
Regulatory Coordinator
SUMMIT MEDICAL GROUP
01.2016 - 01.2022
- Architected site start-up operations for 100+ clinical trials while integrating new practice acquisitions. Performed fastidious documentation management under Nurse Director of Oncology Research to catapult both operational and fiscal excellence.
- Curated careful and conscientious regulatory documentation for central IRB reviews in full alignment with institutional protocols and federal research compliance standards.
- Controlled sponsor queries and prioritized study documentation in full alignment with SOPs, contributing to streamlined workflows and consistent regulatory compliance across trial phases.
Research Data Coordinator
REGIONAL CANCER CARE ASSOCIATES LLC (RCCA)
01.2015 - 01.2016
- Coordinated patient scheduling, follow-ups, and billing under Nurse Director of Clinical Research. Prepared and organized regulatory documentation and confidential research records in accordance with sponsor agreements, the Health Insurance Portability and Accountability Act (HIPAA), and governing regulations. Promoted audits and timely resolution of sponsor queries, ensuring accurate data submission and operational efficiency for optimal trial performance across all studies.
- Processed extensive start-up regulatory documentation and submitted detailed invoices to sponsors for associated fees, supporting compliant trial initiation and aligning financial processes with contractual obligations.
- Systematized patient procedures and follow-up activities to uphold protocol adherence while maintaining research records in strict compliance with confidentiality regulations.
Charge Entry Lead
REGIONAL CANCER CARE ASSOCIATES LLC (RCCA)
01.2008 - 01.2015
- Piloted comprehensive charge entry operations for seamless research claims processing post-transition of HOANNJ into RCCA. Steered project planning and task delegation and liaised with clinical staff to validate accuracy. Formulated future-forward policies to streamline research billing workflows and audited claims to maintain compliance and efficiency.
Accounts Receivable (AR) Specialist
HEMATOLOGY ONCOLOGY ASSOCIATES OF NORTHERN NEW JERSEY (HOANNJ)
- Directed all charge entry operations and reporting information, optimizing claims processing protocols and advancing data accuracy. Reinforced fiscal integrity, expedited reimbursement cycles, and sustained adherence to evolving frameworks.
Education
Licensed Professional Nurse (LPN) -
LINCOLN TECHNICAL INSTITUTE
Iselin, NJSkills
- MICROSOFT 365, INCLUDING WORD, EXCEL, POWERPOINT, & OUTLOOK, Advanced
- Efficient with all industry clinical trial and management (CTMS) and data management systems
- ELECTRONIC DATA CAPTURE (EDC): Medidata Rave
- CIMS Global
- InForm
- IBM
- Veeva Vault
- Castor EDC — INTERACTIVE WEB RESPONSE SYSTEMS (IWRS): Medidata
- Suvoda
- Yprime
- Calyx
- Medable Inc
- EndPoint
- Eli Lilly
- Cenduit
- IQVIA
- Almac
- Signant Health, including TrialMax — IMAGING: AG Mednet
- Virtualscopics
- Perceptive
- Bioclinica
- Clario
- Square / ICON
- Medidata
- PEMS (Patient Tracking and Management Systems)
- Medpace
Certification
- Certified Clinical Research Coordinator (CCRC) — Association of Clinical Research Professionals (ACRP)
- International Air Transport Association (IATA) Safe handling & packaging of clinical trial materials — Mayo Clinic
- Good Clinical Practice (GCP) Certification
- Information Privacy & Security (IPS) Administrative GCP (ICH Focus) for Clinical Research Coordinators
- Essentials of Clinical Trial Budgets
- Clinical Trial Billing Compliance (CTBC)
- Clinical Research Coordinator (CRC)
- Administrative IPS for Clinical Research Coordinators
- Conflicts of Interest for CRC Investigators — CITI Program
- Oncology Nursing Society — Nonprofit organization committed to promoting excellence in oncology nursing and transforming cancer care.
EXCEPTIONAL STRENGTHS
- Clinical Trial Regulation & Leadership
- Patient Recruitment
- Strategic Relationship Cultivation
- Vendor Engagement
- Cross-functional Collaboration
- Project Management
- Continuous Process Improvement
- Standard Operating Procedures (SOPs) & Metrics Delivery
- Time, Cost, & Quality Management
- IRB Compliance
- Electronic Medical Records (EMR) Systems
- Consent & Regulatory Document Review
- Contract Negotiation
- Budget Management & Financial Excellence
- Data & Statistical Analysis
Languages
English
Native or Bilingual
Timeline
Clinical Research Nurse Coordinator
SUMMIT MEDICAL GROUP
01.2022 - Current
Regulatory Coordinator
SUMMIT MEDICAL GROUP
01.2016 - 01.2022
Research Data Coordinator
REGIONAL CANCER CARE ASSOCIATES LLC (RCCA)
01.2015 - 01.2016
Charge Entry Lead
REGIONAL CANCER CARE ASSOCIATES LLC (RCCA)
01.2008 - 01.2015
Accounts Receivable (AR) Specialist
HEMATOLOGY ONCOLOGY ASSOCIATES OF NORTHERN NEW JERSEY (HOANNJ)
Licensed Professional Nurse (LPN) -
LINCOLN TECHNICAL INSTITUTE
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