Emelda Maduakor

• Managed high-volume caseload of 40+ clients, conducting comprehensive biopsychosocial assessments for individualized care plans.
• Coordinated care for veterans and homeless populations with 10+ organizations, achieving 25% increase in housing stability.
• Facilitated interdisciplinary case conferences, aligning clinical providers and specialists to ensure integrated patient-centered outcomes.
• Provided crisis intervention to over 100 clients at risk of hospitalization, facilitating timely referrals to support services.
• Monitored client progress against 10+ outcome metrics, ensuring accurate documentation in EHR systems per HIPAA regulations.
• Advocated for healthcare access and service authorization for over 100 clients, ensuring regulatory compliance throughout process.
• Maintained accurate case files and documentation in compliance with regulations.

Monitored sponsor-initiated and federally funded clinical research studies involving healthy volunteers and patients with endocrinology and oncology conditions. Provided oversight to ensure studies were conducted in compliance with protocol, regulatory requirements, and Good Clinical Practice standards.

• Served as Lead CRA, mentoring and supervising junior monitors.
• Supported investigator site selection, feasibility assessments, and study start-up activities.
• Developed and maintained clinical trial documentation, including source documents, monitoring SOPs, visit templates, and monitoring reports.
• Conducted routine, interim, and close-out monitoring visits to ensure protocol adherence, staff qualifications, and GCP compliance.
• Identified site-level issues and implemented corrective and preventive action plans.
• Performed comprehensive site file reconciliation, reviewing essential and non-essential documents for accuracy, consistency, and regulatory compliance.
• Verified source data, initiated and resolved data queries, and ensured timely data corrections.
• Ensured subject safety through oversight of adverse event reporting to sponsors and IRBs/IECs.
• Reviewed investigational product accountability, storage, and documentation.
• Maintained regular communication with investigative sites and provided timely responses to inquiries.
• Delivered study status updates to cross-functional teams and project management to support timelines and issue resolution.

• Coordinated supply chain logistics for military operations and training exercises.
• Managed inventory levels and ensured timely delivery of essential equipment.
• Implemented safety protocols during the handling and transport of hazardous materials.
• Communicated with vendors to secure necessary supplies and resolve logistical issues.
• Performed quality assurance checks on incoming shipments prior to acceptance into stock.
• Generated reports on inventory status and shipped items using various software programs.
• Implemented strategies to reduce costs associated with logistics operations.
• Developed and maintained supply chain processes in accordance with company standards.
• Monitored inventory levels to ensure availability of essential materials for production.
• Audited supplier performance to identify areas for improvement and cost savings opportunities.
• Implemented and oversaw compliance with safety and handling procedures for all shipments.
• Prepared and maintained accurate shipping documentation, including bills of lading and invoices.
• Conducted regular inventory audits to ensure accuracy and integrity of stock levels.
• Improved profits by streamlining shipping and delivery procedures.

Oversaw the execution and progress of clinical studies at investigative sites, ensuring studies were conducted, documented, and reported in compliance with study protocols, internal SOPs, ICH-GCP standards, and applicable regulatory requirements.

• Led study activities in collaboration with project leadership, investigators, site coordinators, clinical monitors, data management, and analytics teams to support successful study delivery.
• Participated in investigator site selection to confirm site qualifications, training readiness, and resource availability.
• Developed, reviewed, and maintained monitoring documentation, including monitoring plans, visit reports, and corrective and preventive action plans.
• Assigned, coordinated, and supervised daily activities of clinical study monitors to ensure consistent monitoring practices.
• Provided protocol and study training to investigative site personnel.
• Reviewed and approved monitoring reports, tracked outstanding issues, and ensured timely query resolution.
• Escalated compliance concerns and study risks to the Director of Study Management, as appropriate.
• Partnered with coordination and data teams to identify and resolve challenges related to enrollment, data quality, and study progress.
• Conducted on-site monitoring visits as needed to assess protocol adherence, perform source data verification, confirm investigational product accountability and storage, and ensure proper adverse event reporting.

Travel: Approximately 80% during study initiation and as required throughout the study lifecycle; annual workload not to exceed 2,100 hours.

• Coordinated five public health research initiatives and population programs, achieving a 15% increase in community engagement, and improved health outcomes.
• Coordinated three public health programs, meeting regulatory standards, and improving evaluation processes, resulting in a 20% increase in stakeholder satisfaction.
• Coordinated public health activities with health departments, healthcare providers, NGOs, and community stakeholders to enhance service delivery and program reach.
• Conducted epidemiological data collection, surveillance, and outcome analysis to support evidence-based decision-making.
• Developed technical reports and dashboards using Power BI, informing leadership and community partners about key policy decisions.
• Assisted in writing and managing 10+ grants, monitoring compliance, and successfully renewing 90% of funding, while meeting all regulatory requirements.
• Ensured data integrity and regulatory compliance using eTMF systems, enhancing documentation accuracy for research transparency, and audit readiness.
• Applied evidence-based public health strategies to reduce health disparities, and improve population-level outcomes.

• Assist investigators in the development of the nutrition component of research protocols and in the evaluation of results;
• Confer with principal investigators and the Advisory Committee regarding dietary aspects of individual aspects of the specific research diet; provides information of food composition data and balance diet procedures to physicians, and others involved.
• Calculate various types of research diets according to the research protocol and patient's preferences; develops new recipes for highly restrictive and/or specialized diets.
• Assisted in patient recruitment and screening for clinical research projects.
• Scheduled participant visits and ensured adherence to study timelines.
• Facilitated communication between investigators, participants, and sponsors throughout studies.
• Assisted in the preparation of study protocols and informed consent documents for clinical trials.
• Educated clinical study participant and addressed concerns.
• Monitored compliance with FDA guidelines.

• Assisted clients with daily living activities and personal care routines.
• Provided companionship and emotional support to enhance client well-being.
• Monitored client health conditions and reported changes to family or supervisors.
• Managed medication schedules and ensured timely administration for clients.
• Supported bathing, dressing and personal care needs.
• Improved patient outlook and daily living through compassionate care.
• Laundered clothing and bedding to prevent infection.
• Followed care plan and directions to administer medications.
• Observed changes in behavior or physical condition that may require medical attention and reported them promptly to supervisor.
• Drove clients to shop for groceries, attend doctor appointments and run errands.
• Monitored vital signs and medication use, documenting variances, and concerning responses.
• Helped patients during ROM exercises to maintain musculoskeletal functions and increase strength.