DANA SOETAERT
Lawrence,KS
Summary
Accomplished leader with extensive experience in project management and data analysis within the clinical research sector. Developed and implemented innovative research strategies that improved team productivity and compliance. Strong background in training and development promotes effective cross-functional collaboration, leading to successful clinical trials and organizational success.
Overview
24
24
years of professional experience
Work History
DIRECTOR ASSESSMENTS DIVISION
COGNITIVE RESEARCH CORPORATION
St. Petersburg, USA
01.2024 - Current
- Oversaw coordination of assessment operations and project deliverables for data analytics and research.
- Facilitated training sessions mentoring junior researchers in industry best practices.
- Evaluated research proposals for feasibility, ensuring alignment with corporate vision.
- Championed data-driven decision-making processes across the organization.
- Established performance metrics to measure project success and team productivity.
- Collaborated cross-functionally with sponsors, administration, and executive leadership teams.
- Analyzed and interpreted research data to support clinical trial studies.
- Provided operational input for proposals, participating in strategic presentations and business development activities.
MANAGER, ASSESSMENTS DIVISION
COGNITIVE RESEARCH CORPORATION
St. Petersburg, USA
01.2022 - 01.2024
- Led cross-functional teams to develop innovative research strategies.
- Managed project timelines and resource allocation for multiple initiatives.
- Coordinated with stakeholders to align goals and expectations effectively.
- Delivered technical expertise and coordinated cross-functional collaboration on sponsor project deliverables for assessments.
CLINICAL TRIALS ACTIVATION PROJECT MANAGER
YALE COMPREHENSIVE CANCER CENTER CTO
New Haven, USA
01.2022 - 12.2022
- Managed IRB tasks, budgeting, and activation in CTMS while coordinating communication with sponsors and internal stakeholders to meet project timelines.
- Executed activation tasks for Lung Cancer Clinical Trials, ensuring timely enrollment and compliance with regulatory standards.
- Collaborated with Medasource in a contract capacity to fulfill project requirements.
RESEARCH PROJECT MANAGER
FRED & PAMELA BUFFETT CANCER CENTER CLINICAL TRIALS OFFICE, UNIVERSITY OF NEBRASKA MEDICAL CENTER
Omaha, USA
01.2020 - 01.2022
- Managed multiple clinical research projects for a leading cancer center.
- Executed budgeting, contracting, regulatory processes, and training for NCI cancer trials, cooperative projects, and consortium trials to support project goals.
- Supervised clinical trials from selection through execution, ensuring compliance and quality standards.
- Developed project timelines and ensured compliance with regulatory requirements.
- Coordinated communication between research teams and stakeholders for project updates.
CLINICAL RESEARCH SPECIALIST – SITE SUPERVISOR
COTTON O’NEIL CLINICAL RESEARCH CENTER
Topeka, USA
01.2015 - 01.2020
- Expanded Alzheimer’s study portfolio by 400% through application of expertise in neurology and psychological assessments.
- Led development and execution of neuropsychological and psychological assessments, study feasibilities, site trainings, quality audits, and participant enrollment, enhancing collaboration with study sponsors, physicians, and communities.
- Supervised Free Memory Clinic in Northeast Kansas, providing free assessments to patients with memory concerns and increasing pool of potential clinical study participants.
SITE SUPERVISOR, RESEARCH
COTTON O’NEIL CANCER CENTER
Topeka, USA
01.2012 - 01.2015
- Significantly expanded the number of industry-sponsored cancer trials each year while increasing enrollment.
- Supervised projects to ensure adherence to schedule requirements and quality standards.
- Developed training program for new employees on operational procedures and best practices.
- Expanded study portfolio and diversified study panel leveraging expertise.
- Established and maintained close working relationships with staff, clients and vendors.
- Supervised projects to uphold schedule requirements and quality demands.
Clinical Research Coordinator
MEDICAL COLLEGE OF WISCONSIN
Milwaukee, USA
01.2011 - 01.2012
- Transitioned to a remote leadership position with the college overseeing all clinical research operations.
- Coordinated clinical trial activities for multiple research projects, ensuring alignment with study protocols and timelines.
- Managed participant recruitment and informed consent processes for studies.
- Enhanced study creation and execution quality by overseeing hiring, training, and operations of new study coordinators.
- Developed and maintained study protocols and documentation standards.
- Streamlined communication between investigators and study sponsors, improving collaboration and information exchange.
- Monitored study progress, addressing issues as they arose promptly.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Excelled as the first person in the department to function in a 100% remote leadership role.
Clinical Research Coordinator
MEDICAL COLLEGE OF WISCONSIN
Milwaukee, USA
02.2010 - 07.2011
- Directed clinical study start-up, study design, budget development, contract negotiation, and regulatory compliance.
- Contributed to securing National Institutes of Health (NIH) research funding by collaborating with primary investigator on proposal development, leading to successful grant acquisition.
- Transformed the quality of study design, completion, and research publication through ongoing mentorship of residents and ICU fellows.
- Supervised two entry-level clinical research coordinators, enhancing team capability and project execution.
- Facilitated exploration of new research areas in ICU studies, expanding the college's research portfolio.
- Authored numerous publications during tenure about ARDS, Acute Lung Injury, and other respiratory illnesses.
Neuropsychological psychometrist and research coordinator
UNIVERSITY OF KANSAS SCHOOL OF MEDICINE
Wichita, USA
01.2004 - 01.2009
- Led design and execution of neuropsychological, cognitive, and personality assessments, enhancing assessment quality and reliability.
- Administered psychological assessments to evaluate cognitive and emotional functioning.
- Collaborated with healthcare professionals to discuss patient care strategies.
- Created database for managing publications across multiple organizations, streamlining access to research materials and improving collaboration.
Psychology instructor
WICHITA STATE UNIVERSITY
Wichita, USA
01.2002 - 01.2006
Education
MASTER OF ARTS - CLINICAL PSYCHOLOGY
Wichita State University
Wichita, KSBACHELOR OF ARTS -
Wichita State University
Wichita, KSSkills
- Regulatory compliance
- Auditing and vendor management
- Training and development
- Bid preparation and defense
- Data analysis
- Project management
- Performance metrics
- Research design
- Clinical trial management
- Cross-functional collaboration
- Budget development
- Clinical data management
Publications
Available upon request
Highlights Of Impact And Achievement
- Developed patient-facing initiatives for screening to increase patient enrollment in trials, resulting in a 50% improvement in enrollment rates.
- Spearheaded the development of a broader study portfolio to increase study enrollment.
- Developed and implemented a new service line for CRO that was subsequently offered to more than 80% of clients.
- Implemented the transition to eCOA for CRO.
Clinical Operations Expertise
CLINICAL OPERATIONS & DEVELOPMENT, ASSESSMENTS, Clinical trials operations professional experienced in the development and execution of clinical trials in university, hospital, and CRO settings. Clinical psychology master’s degree and extensive experience successfully directing the execution of clinical trials in Neurology, Psychiatry, Oncology, and Pulmonology.
Timeline
DIRECTOR ASSESSMENTS DIVISION
COGNITIVE RESEARCH CORPORATION
01.2024 - Current
MANAGER, ASSESSMENTS DIVISION
COGNITIVE RESEARCH CORPORATION
01.2022 - 01.2024
CLINICAL TRIALS ACTIVATION PROJECT MANAGER
YALE COMPREHENSIVE CANCER CENTER CTO
01.2022 - 12.2022
RESEARCH PROJECT MANAGER
FRED & PAMELA BUFFETT CANCER CENTER CLINICAL TRIALS OFFICE, UNIVERSITY OF NEBRASKA MEDICAL CENTER
01.2020 - 01.2022
CLINICAL RESEARCH SPECIALIST – SITE SUPERVISOR
COTTON O’NEIL CLINICAL RESEARCH CENTER
01.2015 - 01.2020
SITE SUPERVISOR, RESEARCH
COTTON O’NEIL CANCER CENTER
01.2012 - 01.2015
Clinical Research Coordinator
MEDICAL COLLEGE OF WISCONSIN
01.2011 - 01.2012
Clinical Research Coordinator
MEDICAL COLLEGE OF WISCONSIN
02.2010 - 07.2011
Neuropsychological psychometrist and research coordinator
UNIVERSITY OF KANSAS SCHOOL OF MEDICINE
01.2004 - 01.2009
Psychology instructor
WICHITA STATE UNIVERSITY
01.2002 - 01.2006
MASTER OF ARTS - CLINICAL PSYCHOLOGY
Wichita State University
BACHELOR OF ARTS -
Wichita State University