Regulatory Compliance Data Entry

MAXINE MAXWELL, CCRC

Saddle Brook, NJ

************@*****.***

Professional Summary

Detail-oriented and certified professional with extensive experience in coordinating clinical trials across Phases I-IV in Oncology, Cardiology, Infectious Diseases, Devices, Diabetes, and Renal. Skilled in quality management, regulatory compliance, audit readiness, and IRB submissions. Collaborate with sponsors, CROs, investigators, clinical teams, and patients/families to ensure protocol adherence, manage timelines, and streamline multi-site operations. Experienced in SOP development, documentation workflows, and staff training to improve efficiency and compliance. CITI trained, GCP and CCRC certified.

Areas of Expertise

Professional Experience

The University of North Carolina at Chapel Hill, Study Coordinator (Oncology)

Chapel Hill, NC, 4/2024-present

Audit study documentation regularly to guarantee audit-readiness, support sponsor monitoring visits, and facilitate seamless site activation and maintenance. Apply pharmaceutical and quality auditing expertise to proactively identify regulatory gaps, mitigate compliance risks, and prevent protocol deviations before they escalate. Cultivate effective communication between the clinic and research staff to enhance collaboration, optimize workflows, and drive a culture of accountability and transparency.

•Support Oncology trials by assisting in preparing and reviewing study documents for IRB, including, but not limited to, knowledge of clinical protocols and amendments, informed consent forms, budgets, and site regulatory binder.

•Review medical histories and pathology reports, randomize, and enroll study patients for treatment.

•Maintain Electronic Data Capture systems, ensuring smooth data collection and data entry throughout the study period.

•Continuously audit files to facilitate Sponsor monitor visits and the study site startup team.

Validated Claim Support, Quality Specialist- Teaneck, NJ 2/2022-9/2023

Contributed to the development and refinement of research procedures and SOPs by applying expertise from prior experience in regulatory documentation with large pharmaceutical sponsors to accelerate workflows and compliance. Pioneered on-site audit model by integrating Quality Auditors into patient-facing roles, proactively detecting documentation and procedural errors, eliminating risk, and elevating participant and clinician satisfaction through real-time issue resolution.

•Established an audit process that embedded a Quality Auditor directly in a patient-facing position, which proactively caught errors, enhanced accuracy, and ensured a smooth experience for both participants and clinicians. This helped mitigate risks and improved vendor and participant satisfaction.

•Reviewed protocols, Informed Consent Forms (ICFs), and other case report forms and ensured compliance with the Sponsor's signed quotes, Standard Operating Procedures (SOPs), and regulatory requirements.

•Identified opportunities for Corrective Actions and Preventive Actions (CAPA) and developed corresponding action plans.

ICON on Project for Sanofi Aventis-Clinical, Project Assistant II- Bridgewater, NJ 6/2020-9/2021

Drove regulatory compliance and operational efficiency across clinical trial sites through strategic coordination and document management. Streamlined training protocols for CRAs and site teams to boost submission efficiency, minimize errors, and shorten turnaround times for essential documentation. Coordinated and monitored clinical trial supply logistics to ensure accurate, on-schedule delivery of study materials and maintain continuity of trial operations.

•Attended meetings with Clinical Research Associates (CRAs) and sites to retrieve outstanding documents, which ensured compliance and training for staff.

•Maintained and reviewed paper and Electronic Investigator Site Files to ensure completeness and quality of the documentation, while working with Regulatory bodies, sites, and CRAs to maintain compliance.

•Developed and refined training approaches that improved efficiency, resulting in faster turnaround times for document submissions from CRAs and sites.

•Managed logistics for handling and shipping clinical trial supplies to ensure timely and accurate delivery to sites.

First Light Home Care, Operations Manager - Parsippany, NJ, 11/2017-3/2020

Optimized client care and strengthened team performance through strategic coordination and staff engagement. Designed and executed process improvements to fuel operational efficiency, decrease downtime, and amplify caregiver scheduling effectiveness. Spearheaded morale-boosting initiatives—such as training incentives, staff recognition programs, and merit-based raises to curb turnover, retain skilled CNAs, and ascertain agency stability during COVID-19 crisis.

•Assisted in conducting home assessments, coordinated with facility staff and medical providers to develop care plans, and established a positive start of service for clients and caregivers.

•Monitored service shifts, including caregivers’ clocking in and out, late alerts, and caregiver claims (hours worked, mileage, and activity notes).

•Worked with the Veterans Service to coordinate care and placement for veterans.

Wockhardt USA-Clinical, Project Assistant- Parsippany, NJ, 9/2012-5/2015

Propelled global clinical trial success through expert regulatory oversight, site coordination, and stakeholder communication. Served as primary liaison between study sites, CROs, and monitors to foster effective communication, resolve issues proactively, and confirm completion of all regulatory and training milestones before drug shipment. Delivered strategic technical and administrative support to Senior Vice President of Global Research and Senior Trial Manager to drive global clinical trial operations and project execution.

•Provided technical and administrative support to the Senior Vice President of Global Research and the Senior Trial Manager for Global Research Clinical Trial projects.

•Coordinated the distribution, retrieval, and review of regulatory documents needed for clinical trial initiation in collaboration with the clinical project team.

•Reviewed regulatory documentation to support study start-up activities, ensured all site supplies are available on site for site initiation visits, and sites are ready for activation and enrollment activities.

Hackensack Meridian Health, Clinical Research Coordinator- Hackensack, NJ, 8/2003-5/2011

•Managed clinical trials focusing on disorders such as diabetes, cardiology, renal failure, hypertension, and infectious disease and facilitated daily trial activities which ensured compliance with research protocols.

•Ensured full compliance with ICH GCP standards and maintained the integrity of clinical trial documentation.

•Assisted in negotiating study budgets for billing research procedures.

•Reviewed Informed Consent Forms (ICFs), and contracts and ensured that standard Institutional language are maintained for patient protection and compliance.

•Facilitated a team effort between clinical practice and research staff, which reduced errors and created trust with our research patients.

•Submitted site study start-up, study continuation, and amendments through closeout to Institutional IRB and Central IRB.

Education & Certifications

CITI Trained

Certified Clinical Research Coordinator (CCRC) – ACRP

Associate’s degree-Excelsior College- Business Administration

MM

Contact this candidate