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Clinical Research Quality Management

Location:
Germantown, MD
Posted:
July 28, 2023

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Resume:

Olajumoke (Jumi) Owati, MPH, MS, RMA

●adyky4@r.postjobfree.com ● 443-***-**** ●Ellicott City, MD

PROFESSIONAL SUMMARY

Accomplished healthcare professional with over a decade of experience providing quality hands-on clinical, and administrative patient-centered and quality-oriented services. Readily adaptable to change, understands agile methodologies, team communication, process improvement, and change management within the healthcare system—continuous development by earning a post-graduate degree in public health.

Accomplished Researcher: Expert clinical research professional, skilled in screening participants, conducting recruitment phone pre-screening and surveys, and collecting and entering data to help the research team deliver accurate results and meet deadlines during phases 1 – IV of clinical research. Proven experience with regulations regarding research projects.

Experienced Quality Management Lead Auditor: Credited to reduce non-conformances by 100% and ensure customer satisfaction in other departments by ensuring adherence to ISO 9001:2008 quality management processes.

Project Management: Demonstrated ability to exceed target goals and ensure cost savings through compliance and conformance with customer-oriented policies. Excellent data analysis, administrative, and management skills.

Healthcare professional: Proven knowledge of Good Clinical Practices (GCP) while conforming to ethical standards. Culturally competent, strategically oriented, and readily adaptable to change. Effective communicator with the ability to collaborate with colleagues and engage with stakeholders.

AREAS OF EXPERTISE

Project Management

Media Referral Processing

Prescreening

Scheduling Appointments

Good Clinical Practices

Biostatistics

Data Analysis and Interpretation

Electronic Health Record & Medical Terminology

Referral Physician Networking Efforts.

Public Health Campaign

Insurance verification, billing, and coding

Oral & written communication

HIPAA

CERTIFICATIONS

Advanced Clinical Trial Assistant Certification by the Certified Clinical Research Professionals Society (CCRPS)

Protecting Human Research Participants' Online Training

Good Clinical Practice Certification by the Association of Clinical Research Professionals (ACRPS).

Understanding Clinical Trial Protocols Certification by the Association of Clinical Research Professionals (ACRPS).

American Medical Technologist Certification.

ISO 9001:2015 & Six Sigma Green Belt Quality Management Certified

Clinical Research Coordinator Basic Training Certification by Northwestern University Clinical and Translational Sciences (NUCATS) Institute.

MSOW Healthcare Credentialing Certification.

CAREER EXPERIENCES

Patient Engagement Associate (Remote) April 2022 – Present

Elligo Health Research

Supports trial-specific patient recruitment and retention efforts, working with a Patient Recruitment & Retention Lead to oversee the strategy development.

Monitors the recruitment of a potential base within the community and oversees efforts geared to improve client retention.

Collaborates with the clinical research team to ensure timely prescreening of potential subjects and or active cancer patients for all available clinical trials.

In collaboration with the Research Nurse Clinician (RNC) and/or physician, reviews the patient’s charts and medical history to confirm protocol eligibility and obtain source documents (i.e., medical record documentation) as needed.

Participates in the development of informational and/or educational materials and literature.

Answers patient telephone calls. Correctly processes information for appointment scheduling, answers questions, and assists with problem-solving. This includes but is not limited to triaging emergent/urgent phone calls, inquiries related to the availability of clinical trials, scheduled appointment dates and times, parking, direction, and general practice information.

Serves as an essential link between patients and all other research team members for the effective completion of clinical studies.

Proofread and edit materials during development and provide feedback on design elements and written content.

Coordinates closely with sites to effectively leverage practice management systems, EMRs, and other tools to obtain patient data and perform outreach.

Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.

Assist the clinical team with preparing, handling, distributing, filing, and archiving clinical documentation and reports according to the scope of work and standard operating procedures.

Assist CRAs with preparing, handling, and distributing Clinical Trial Supplies and maintaining tracking information.

Assist with the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow.

Acts as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.

Trained patient engagement trainees on how to perform outreach for recruiting participants from different stages of clinical trial studies.

Public Health Intern Jul 2021- April 2022

Howard County Health Department /Howard County General Hospital

Columbia, MD

Led project initiation, planning, and execution of the Aronson Willis Memorial Award Application 2022.

Triaged routine provider issues and internal inquiries regarding policies and procedures, the resignation of providers in the MSOW database, credentialing or claims status, orientation activities, and portal usage.

Served as primary source verification of license, relevant training, and competence of professional staff. And ensures that providers’ expirable like DEA, Controlled substance certificates, and state licenses are up to date.

Effectively communicated confidential and privileged emails and mails following HIPAA standards.

Supported diabetes prevention program by preparing focus group questions to assess current health needs, barriers, and potential solutions to each of the following: Fruit and vegetable consumption, screen time, water consumption, and physical activities among Howard County residents.

Developed campaign documents to promote the cessation of smoking among pregnant women.

Handled basic bookkeeping tasks including preparation of financial statements, reports, memos, invoices letters, and other documents for proper documentation and audit preparation

Researched and compute data to prepare organizational documents for review and presentation by boards of directors, committees, and executives.

Certified Medication Technician March 2020 - February 2021

Brightview Senior Living, Catonsville, MD

Recorded patients' vital signs, dispensed medication to residents, and documented changes in the residents’ medical conditions.

Contributed to the development of a care plan for each resident and instructed caregivers to adopt the plan

Delegated duties to caregivers and documented incident data reports for follow-up by the management.

Achieved 100% accuracy in the dispensation of medication to residents by following the SOPs and care plans for each resident.

Reduced unintentional fall rates by 50% through effective management of the caregivers.

Health Data Associate Internship July 2019- December 2019

Bozeman Clinic Bozeman, MT

Used AthenaNet and Epic software packages to abstract and update patients' data into Electronic Medical Records following technical specifications to ensure high-quality content of medical records while maintaining Health Insurance Portability and Accountability Act (HIPAA) standards and confidentiality of protected health information.

Managed health data according to the SOPs, presented data reports, and recommended the need for additional health information from identified patients as needed for clinical reviews and compliance.

Revamped the health documentation processes in the clinic and prepared a template for subsequent data associates.

Collaborated with medical providers and office management to determine billing and documentation policies and ensure compliance.

Implemented the setup of new practice management software.

Researched insurance policies/eligibility and educated medical staff.

Provided administrative support to physicians and interpret data to assign ICD-10.

Entered CPT codes and patient information into billing software.

Reviewed and validated the accuracy of charges including dates of service, services provided, location, and provider signature.

Quality Management Auditor and Customer Relations Officer September 2010 - December 2015

Etteh Aro & Partners Firm

Led the quality management department and supervised the firm’s Quality Management System (QMS).

Controlled end-to-end projects’ lifecycle quality requirements by ensuring that QMS processes are established, implemented, maintained, identified any improvement needs, and reported to Top Management. Supported the preparation of contract-required reports in conformance with quality management.

Achieved NO contract loss.

Boosted project approval rate for the organization by 90% by presenting findings and recommendations to the project/program management and conducting seminars for other members of the organization on implementing the Quality Management System (QMS).

EDUCATION

Masters of Public Health Degree Concordia University, Nebraska (2020-2023)

Masters of Science Degree in Crop Protection University of Ibadan, Nigeria (2012)

Associate Certificate in Medical Assistant Montana State University, Bozeman (2019)

Bachelor's Degree in Ecology and Environmental Sciences--- University of Ibadan, Nigeria ( 2003 – 2008)

TECHNICAL PROFICIENCIES

Proficient in the use of statistical tools: SAS, SPSS.

Understands data visualization using: Tableau Reader, Power B.I., and Minitab.

Proficient use of Project Management tools including M.S. Project, MS Teams, and Jira.

Proficient use of Microsoft Office tools, including Microsoft Excel, PowerPoint, and Word.

Process Management (using Lean and Six Sigma Methodologies).

Various EMR softwares ( NextGen, Epic, and AthenaNet).



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