Dana Acklin Winfrey
Cincinnati,OH
Summary
Highly skilled Clinical Research Project Manager with expertise in overseeing and coordinating all aspects of clinical trials from start-up to close-out. Proficient in protocol development, site selection, patient recruitment, and data analysis. Demonstrated strengths in strategic planning, team leadership, and regulatory compliance. Proven track record of successfully completing research projects and contributing to advancements in the field.
Overview
15
15
years of professional experience
Work History
Clinical Research Project Manager
NIH National Coordinating Center at UC
Cincinnati, OH
04.2018 - Current
- Implemented a variety of clinical research protocols while simultaneously designing consent forms, case report forms, and other study documents.
- Conducted training sessions for personnel on study-specific safety protocols and clinical research procedures.
- Established and monitored timelines and budgets for site and participant payments.
- Coordinated with research staff to ensure compliance with applicable laws and regulations governing clinical trials.
- Conducted site feasibility visits and interviews with Principal Investigators and study teams, and created detailed reports summarizing the data.
- Assisted in the development of protocol amendments as needed throughout the course of a study.
- Created presentations summarizing project goals, advancement status updates along with outcomes interpretation to various stakeholders.
- Maintained accurate records of all study-related activities including finances and communication logs.
- Participated in the design of recruitment strategies for participants in clinical studies.
- Identified potential vendors providing services such as laboratory testing or imaging services required by a study protocol.
- Reviewed relevant medical literature to determine best practices for conducting particular types of clinical trials or collecting specific types of data from participants.
- Provided technical support to investigators regarding regulatory requirements related to their respective studies.
- Developed systems for tracking adverse events reported during a trial period.
- Acted as liaison between sponsor organizations and investigative sites when necessary.
- Ensured timely completion of all deliverables associated with each project within budget constraints.
- Kept patient care protocols and clinical trial operations in compliance.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Monitored subject enrollment and tracked dropout details.
- Prepared materials for Investigators' Meetings and presented portions of each meeting.
Senior Clinical Research Coordinator
CTI Clinical Trials
Cincinnati, Ohio
11.2013 - 03.2018
- Developed and maintained regulatory documents for clinical trials.
- Ensured adherence to protocol guidelines by monitoring study progress and documenting adverse events.
- Conducted training sessions for new team members on Good Clinical Practice and ICH regulations.
- Conducted pre-study site visits to assess compliance with protocols and applicable regulations.
- Assessed potential sites for suitability as trial participants.
- Organized investigator meetings, prepared agendas, collected presentations, and took minutes at meetings.
- Provided technical support to investigators regarding data entry into electronic case report forms.
- Reviewed source documentation for accuracy of data entered into eCRFs.
- Collaborated with internal departments such as Regulatory Affairs, Data Management, and Biostatistics to ensure timely completion of studies.
- Performed quality control checks on eCRF data by reviewing discrepancies reported by Data Management staff or generated from database queries.
- Created detailed reports summarizing study status, patient recruitment efforts, enrollment trends.
- Maintained accurate records of study documents including CRFs, informed consents, laboratory results.
- Participated in safety review boards to evaluate the safety profile of investigational products.
- Served as a liaison between sponsors, investigators, vendors throughout the duration of the study.
- Evaluated vendor performance related to project deliverables such as supplies or services provided.
- Prepared financial reconciliation statements for each site involved in the trial.
- Managed the development of study materials such as questionnaires or training manuals.
- Facilitated communication between research personnel at multiple sites.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
Lead Clinical Research Coordinator
Cincinnati Children's Hospital and Medical Center
Cincinnati, OH
07.2009 - 11.2013
- Assisted in development of procedures for efficient collection, analysis, and reporting of data.
- Interpreted complex statistical data sets from clinical trials using specialized software programs.
- Generated timely responses to queries from sites regarding protocol-related information.
- Researched literature pertaining to specific therapeutic areas as needed.
- Developed and maintained clinical trial documents, such as protocols, case report forms, and informed consent forms.
- Reviewed patient charts for accuracy prior to data entry into the database.
- Managed drug supply inventory for multiple trials.
- Monitored laboratory results to ensure quality control of data collected.
- Collaborated with project managers to identify potential issues that could affect the timeline of a study.
- Liaised with external vendors for services related to clinical trials including contract research organizations and imaging centers.
- Provided support in preparation for FDA inspections including review of relevant documents.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Collected, processed and delivered specimens from trial participants.
- Conducted screening interviews to determine eligibility of possible subjects.
- Monitored subject enrollment and tracked dropout details.
- Educated participants on studies and anticipated outcomes.
- Took vital signs and collected medical histories as part of study protocols.
- Placed orders for medications to be used in studies.
Education
Bachelor of Science - Biopsychology
University of Cincinnati College of A&S
Cincinnati, OH12-1999
Skills
- Adaptability
- Problem-solving aptitude
- Attention to Detail
- Time Management
- Continuous Improvement
- Trial oversight
- Multitasking
- Protocol development
- Stakeholder Communication
- Project Planning
- Team Management
- Study design
- Proficient in Microsoft Office Products
- Document Management
- Budget Control
- Training and mentoring
- Excellent Communication
- SOP development, review and updates
- Proficient in PowerPoint creations
Timeline
Clinical Research Project Manager
NIH National Coordinating Center at UC
04.2018 - Current
Senior Clinical Research Coordinator
CTI Clinical Trials
11.2013 - 03.2018
Lead Clinical Research Coordinator
Cincinnati Children's Hospital and Medical Center
07.2009 - 11.2013
Bachelor of Science - Biopsychology
University of Cincinnati College of A&S
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