Chelsea L. Hudlow Email & Phone Number

Responsible for overseeing and managing US site clinical operational activities at the trial and site level for cardiovascular post-market multi-center data collection registries, while providing guidance to site clinical research coordinators, principal investigators, and vendors. Conducts study start-up activities, including protocol development and regulatory document review, ensuring compliance with study requirements and GCPs as well as virtual/in person site visits. Develops clinical trial timelines, enrollment projections, and instructional materials while leading process improvement initiatives within the department and cross functionally, including SOP development.

Aurora, Colorado, United States

Oversaw and managed clinical research operations for Phase 1-4 cardiovascular device/pharmaceutical trials. Provided leadership and direction to cross-functional teams, ensuring efficient study execution and adherence to regulatory guidelines. Directed vendor oversight activities, including contract negotiations and performance evaluations, to ensure studies met expected milestones with quality, efficiency, and within budget. Served as the primary Clinical Trial Manager for EU and Brazil.Proven Success & Impact:▪ Reduced individual manual workload per week by 20% for site management by managing a cross-team process improvement project to automate monthly site progress and metric reports across 120 sites globally to reduce manual workload and increase accuracy; restructured data flow across 4 departments and implemented trainings.▪ Implemented and maintained robust data management processes, ensuring accurate and timely collection, analysis, and reporting of clinical trial data. Utilized CTMS software and electronic data capture systems to track and monitor study progress, ensuring data integrity and regulatory compliance, as well as risk mitigation and management.▪ Ensured compliance with eCFR, SOP, and CSR development standards, maintaining comprehensive TMF documentation and collaborates with internal and external stakeholders, including study sites, vendors, and sponsors.▪ Reviewed monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, SEVs, SIVs, RMVs, and COVs, while managing CRA teams to clarify issues and finalize reports and follow-up letters. Maintained robust documentation of site communications, document status, and protocol deviations.

Supported the planning and execution of neurologic clinical research studies and manages CTMS. Performed clinical leadership-related responsibilities and CRO/vendor oversight activities to ensure studies were executed with quality and efficiency, on time, within budget, and in support of both company objectives and AbbVie's mission to discover and deliver innovative medicines.Proven Success & Impact:▪ Supported and managed cross-functional study teams' communications, deadlines, adherence to monitoring plans, and expectations while regularly communicating with stakeholders on study status. Proactively identified and resolved study issues across different groups, and successfully brought several global studies to final data lock on schedule.▪ Responsible for generating study-related training for the study team, study sites, and vendors for assigned studies. Created site-facing materials, managed IRB/FDA approval submissions, and performed in-house data review.▪ Managed matrixes of functional areas and assisted with developing study protocols, associated systems, and documents. Coordinated vendor selection, scope development, and study-related trainings for sites/vendors.

Executed Phase 1 -4 general medicine, memory, NASH, pain and medical device clinical research visits and activities in accordance with FDA, SOPs, GCP, and ICH guidelines. Organized study start up and implementation. Dispensed investigational products, performs in-depth medical screening, and ensures a flow of communication between subject, study staff, Sponsor and CRO, monitor(s), and Auditors. Lead coordinator on NAFLD, NASH, and adhesive capsulitis studies.Proven Success & Impact:▪ Articulated protocol issues to CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator, and other members of the study team. Maintained timely internal source documentation as well as sponsor-required information.▪ Facilitated study monitoring visits and prompt resolution of all study related queries and completed a variety of reports, documents, and correspondence for regulatory agencies.▪ Performed clinical tasks, including vital signs, height & weight, ECG, and specimen packaging. Reviewed subject comprehensive medical documentation to determine protocol eligibility. Provided excellent patient customer service.

Orlando, Florida Area

Formerly Bioclinica ResearchCoordinated outpatient and Phase 1 clinical trials conducted by supervising Principal Investigator in accordance with FDA, GCP, and protocol guidelines. Dispensed investigational products, maintained accurate records, performed in depth medical screening, and ensured a flow of communication between patient, study staff, Sponsor and/or CRO, monitor(s), and Auditors.Proven Success & Impact:• Articulated protocol issues to CRO and/or Sponsor, Site Administrator, Director, Principal or Sub-Investigator, and other members of the study team. Maintained timely internal source documentation as well as sponsor-required information while completing all monitor and sponsor queries in a timely manner.• Performed clinical tasks including vital signs, height & weight, ECG, and specimen packaging. Reviewed subject comprehensive medical documentation to determine protocol eligibility.

Orlando, Florida, United States

Assisted Clinical Research Coordinators, requested and maintained accurate records of patient medical history, performed initial patient recrtuitment, intake and screening, and ensured a flow of communication between patient, study staff, and Principal Investigator.Proven Success & Impact:• Conducted initial psychiatric and medical screening with patients while coordinating with study staff and adhering to study protocols.• Performed clinical tasks including vital signs, height & weight, ECG, and specimen packaging while obtaining medical records.

Orlando, Florida Area

Oversee the reviewing and processing of therapy referrals, coordinate treatment plans, and interact with various medical professionals towards the goal of excellent patient care.Proven Success & Impact:• Established a close working relationship with nurse case managers, therapists, and other healthcare professionals to facilitate urgent scheduling of therapy, transportation, MRI's, and CT scans for both low and high-risk patients.• Expedited patient referrals to specialty offices, faxed medical records, answered patient and specialty office calls and completed referral requests.

Orlando, Florida Area

Handle customer facing dining services, accommodating guests for outstanding restaurant and dining services. Proven Success & Impact: • Implement corrective plans of action to solve customer complaints and problems. • Assist with the coordination of staffing schedules, training, and development to ensure and effective operations. • Manage POS systems and cash collection with perfect financial accuracy. Ensure that federal, state and company regulations regarding cleanliness and food preparation are in full compliance.

Phoenixville, Pa

Conducted administrative duties, filing documents and updating information utilizing database software. Effectively and efficiently documented reporting and other paperwork.Proven Success & Impact:• Handled information from phone calls, email, physical mail, while composing, proofreading and editing all outgoing correspondence, quotations, and memos.• Managed schedules, meetings, engagements, and other appointments.

Certificate Of Completion - Foundations Of Clinical Research

Master Of Research Administration, Clinical Research, 4.0

Activities and Societies: SDS Advisory Council / Pride Coalition

Bachelor Of Pre-Clinical Health Sciences, Minor Of Psychology

Activities and Societies: SDS Advisory Council / Pride Coalition / Student Development and Enrollment Services Vice President Student.