Data Entry Clinical Research

Loretta Gleaton Williams, MPH, CCRP

**** ****** ***** ****. ******** Village, Ohio 44143

(Cell) 216-***-****

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

Health Services & Regulations Employment History

Kelly Services

Program Coordinator I September 2022 to Present

Resolve any discrepant or missing information on study materials via email or phone. Appropriately document and track for resolution all study communications.

Send study materials and certification materials to national and international study sites.

Perform accurate and timely data entry in tracking logs

Develop forms/spreadsheet, proof, edit and create correspondence

Maintain office supplies and equipment

Scheduling, calendar maintenance, monitor phones

Provide administrative support as needed to Project Managers and Directors

Case Western Reserve University

Office of Research and Technology

Data Use Agreement Manager November 2021-Apil 2022

Conduct the evaluation and processing of data use agreements relate to data transfers to and from Case Western Reserve University.

Evaluate data use agreements for sponsored projects to identify data risk level, Institutional Review Board (IRB) implications, and necessary revisions.

Review Institutional Review Board (IRB) research protocols for agreement compliance.

Track and record data use related agreements and confirm compliance with University Technology data security personnel, Health Insurance Portability and Accountability Act (HIPAA), and human subject protections.

Maintain current information and understanding of federal regulations, ethical considerations, and the university Institutional Review Board (IRB) and university research policies related to data and protection of human research including knowledge of the United States and European Union data protection and privacy laws, the Common Rule, Federal Demonstration Partnership, and other human data safety regulations.

Cleveland Clinic Foundation- Cleveland, OH

Department of Rheumatology

Clinical Research Coordinator II June 2020-November 2021

Coordinates the implementation and conduct of research projects ensuring adherence to research protocol requirements which may include the following: maintenance of regulatory documents and binders, data management, IRB submissions and communication of such to the research team.

May be responsible for reporting/completion of Serious Adverse Events and/or safety log as defined per protocol as they occur and completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP guidelines.

Communicates with sponsors, monitors, research personnel to ensure all aspects of study compliance.

Completes regulatory documents, data capture and monitoring plans.

Completes protocol related activities.

Monitors research data to ensure data collection is compliant per protocol.

Demonstrates comprehension of assigned research protocols.

Develops and maintains knowledge of research protocol to coordinate the comprehensive and compliant execution of assigned protocols.

Assists with preparation for audits and response to audits.

Documents the education and training of research personnel as needed.

Participates in the conduct and documentation of the informed consent process.

University Hospitals Cleveland Medical Center (UHCMC) - Cleveland, OH

Department of Radiology-Research Administration

Clinical Research Regulatory Specialist III April 2018-May 2020

Coordinated the regulatory operations for clinical research studies conducted by Principal Investigators in the Department of Radiology.

Performed all activities related to clinical research studies including but not limited to: Screening participants for eligibility and recruitment, obtains informed consent, educates participants regarding study requirements, and completion of case reporting forms.

Documented, recorded, and assimilated accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies.

Established and maintain communication with Investigator, Sponsor, and internal constituents.

Reviewed contract exhibits to draft initial research protocols for IRB review.

Responsible for submission of study-related documents to the appropriate regulatory review committees and maintenance of regulatory files/binders.

Coordinated and performed study specific regulatory processes across multiple complex studies of different areas and phases, including IND or IDE held investigator-initiated trials.

Maintained compliance of investigator-initiated and industry-sponsored projects in compliance with departmental SOPs, GCP guidelines, sponsor guidelines, and federal regulations.

Led the process to communicate and describe regulatory requirements to investigators.

University Hospitals Clinical Research Center

Research Compliance and Education Specialist I, II, and III April 2013-April 2018

Conducted and reported audit findings of clinical monitoring of investigator-initiated drug and device clinical trials at University Hospitals Case Medical Center (UHCMC) and at the Francis Payne Bolton School of Nursing and School of Dental Medicine at Case Western Reserve University (CWRU).

Promoted the integrity of human subjects research in accordance with guidelines according to the ICH, Good Clinical Practice (GCP) guidelines, the Office of Civil Rights, the FDA, OHRP, industry contracts, data use agreements, and local and institutional requirements during the monitoring and auditing of protocols to ensure the safety and welfare of research participants.

Complied with reporting requirements of clinical studies per FDA and OHRP regulations.

Maintains knowledge of regulatory changes to the FDA, Office of Civil Rights, and OHRP and identify opportunities for quality improvement, education, and training for researchers at UHCMC and CWRU.

Conducted audits of possible allegations non-compliance for UHCMC Institutional Review Board (IRB)-approved projects and as required, summarizes findings for reporting to the appropriate Federal agency.

Maintained positive liaisons with research agencies and sponsors/partners.

Developed and maintained policies and procedures for the UHCMC’s Institutional Review Board (IRB) and the Office of Research Compliance and Education.

Served as a committee member of the UHCMC IRB Board.

University Hospitals Cleveland Medical Center - Cleveland, OH June 2005-April 2013

UH Clinical Research Center

Senior Human Subjects Protections Specialist

Led administrative electronic processes and activities for the Institutional Review Board (IRB) for all health care facilities within UHCMC

Conducted review of research protocol submission/review and related internal education initiatives.

Managed with a staff of six IRB Specialists over 1400 active protocols, interpretation of policies and procedures for human subjects’ research within 21 academic departments & 30 clinical divisions using industry software modules.

Communicated detailed status of IRB committee reviews of research protocols via written reports to researchers for IRB review.

Served as a resource for investigators, providing interpretations of federal policies from the FDA and OHRP for national and international studies.

Served as an IRB Board member.

Developed and updated departmental and institutional policies in accordance with federal and hospital policies guiding the oversight of living human subjects’ protections in research.

Conducted one-on-one training, consultation, and education programs with researchers to facilitate IRB submissions, reviews, and follow-up correspondence of the Board’s comments prior to IRB approval.

College Education

The George Washington University, School of Public Health and Health Services

Master Public Health

Specialty: Health Promotion and Disease Prevention

Central Piedmont Community College

Associate Science, Respiratory Therapy Technology

Lenoir-Rhyne University

Bachelor of Arts, Sociology

Continued Education and Training

Managing Federal Grants and Cooperative Agreements for Recipients

Practical Management Skills for Health Educators - (Johns Hopkins School of Public Health)

Professional Licensure & Certifications

Certification in Human Research Subjects since 2005

Certified Clinical Research Professional (CCRP) Society of Clinical Research Associates (2013 to 2025)

Good Clinical Practice (April 2018 to April 2025)

Proven strong written communication skills to write and edit documents with the ability to take scientific documentation and present to the study team.

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