Anisa Cline, MSN, RN
Fredericksburg,VA
Summary
Accomplished healthcare, clinical research, and regulatory leader with over 25 years of experience in operational excellence and regulatory compliance. Demonstrated ability to reduce study start-up timelines and manage cross-functional teams effectively. Expertise in strategic planning, audit readiness, and stakeholder engagement to deliver complex clinical trials efficiently.
Overview
2026
2026
years of professional experience
3
3
Certifications
Work History
Manager of Regulatory & Clinical Documentation
ObjectiveHealth
Franklin, TN
05.2021 - Current
- Achieved a 52% reduction in clinical trial start-up time within 12 months through effective process optimization.
- Oversaw compliance and regulatory documentation for 35 sites conducting multi-therapeutic Phase I–IV clinical trials.
- Led the successful onboarding of the eISF platform, enhancing clinical trial documentation processes, and improving operational efficiency.
- Streamlined workflows and standardized operating procedures to boost operational efficiency.
- Directed site readiness, IRB submissions, and sponsor communications for multicenter clinical studies.
- Coordinated internal audits achieving positive compliance outcomes and strengthening audit readiness.
- Developed policies and procedures to ensure compliance with corporate standards.
- Monitored project timelines and ensured adherence to deadlines and standards.
- Coordinated cross-departmental initiatives to streamline processes and communication.
Site Director
ObjectiveHealth
02.2021 - 05.2021
- Led clinical research operations from initiation to completion, ensuring timely achievement of project milestones and protocol adherence.
- Directed the IRB submission process, encompassing reviews and reporting activities to ensure compliance with regulatory standards.
- Served as key liaison among stakeholders, fostering effective collaboration while maintaining strict adherence to HIPAA regulations.
- Managed training programs for new employees to enhance skill development.
- Developed strategic partnerships with local healthcare providers for collaboration.
- Provided guidance, direction, and support to ensure completion of projects on time and within budget.
- Managed relationships and contracts with vendors, contractors, and other external stakeholders.
Telephonic Nurse Case Manager
Paradigm Complex Care Solutions
Sioux Falls, SD
08.2020 - 02.2021
- Directed comprehensive case management for injured individuals, achieving cost-effective interventions and optimized recovery outcomes.
- Served as primary liaison among insurance carriers, medical providers, attorneys, employers, and injured workers to ensure effective communication.
- Monitored medical treatment progress, implementing strategies for timely return-to-work and enhancing patient satisfaction.
- Provided emotional support to patients and their families during recovery processes.
- Counseled patients on self-management techniques such as medication adherence and symptom management.
Supervisor, Special Programs Unit
Paradigm Complex Care Solutions
Sioux Falls, SD
06.2019 - 05.2020
- Directed team of nurse case managers to ensure compliance with clinical protocols and quality standards.
- Developed quality improvement initiatives that reduced error rates by 86% in 14 months.
- Implemented strategies to enhance patient outcomes across multiple care settings.
- Managed specialized programs for high-risk populations, improving engagement and care coordination.
Quality Improvement Auditor
Paradigm Complex Care Solutions
Sioux Falls, SD
01.2019 - 06.2019
- Designed and implemented advanced tracking tools for audit deliverables, ensuring compliance and accuracy in reporting.
- Spearheaded organization-wide Quality Taskforce, leading quarterly training initiatives that enhanced compliance by 25%.
- Collaborated with cross-functional teams to identify areas for process improvement.
- Assisted in preparing audit plans based on established objectives and standards.
Manager, Telephonic Case Management
Paradigm Complex Care Solutions
Sioux Falls, SD
03.2018 - 01.2019
- Launched telephonic nurse case management program with insurer, managing 65–80 active claims.
- Resolved client issues and escalated critical concerns for timely care coordination.
- Effectively managed referrals to specialty services and community resources.
- Coordinated patient care plans with interdisciplinary teams and healthcare providers.
Pharmaceutical Independent Consultant
Cline Consulting, Inc.
Fredericksburg, VA
01.2015 - 03.2018
- Oversaw document lifecycle management, maintaining 100% compliance with FDA and Sponsor standards.
- Directed regulatory document strategy and compliance, ensuring accuracy in investigator site submissions.
- Facilitated cross-functional regulatory consortium to enhance collaboration across stakeholders for multi-therapeutic trials.
- Managed filing in clinical trial master file while tracking CDAs, protocols, amendments, and IRB approvals.
- Coordinated project timelines and deliverables across multiple teams.
- Mentored junior consultants on best practices and methodologies.
Director of Quality Improvement & Risk Management
Spotsylvania Regional Medical Center
Fredericksburg, VA
08.2012 - 01.2015
- Advised senior leadership on strategies to enhance health plan core measures and KPIs for Medicare-Medicaid programs, ensuring compliance with regulatory requirements.
- Led quality improvement initiatives that elevated CORE measure scores by 32% organization-wide, enhancing patient outcomes.
- Conducted root cause analysis of patient care trends, developing targeted action plans to resolve systemic issues.
- Developed a risk reduction program, achieving a 29% decrease in preventable incidents, and improving patient safety.
- Developed staff training programs that embedded quality practices and reinforced adherence to regulatory standards.
- Spearheaded implementation of medical case review process for patient grievances, enhancing resolution timelines and satisfaction.
- Oversaw reporting of patient care benchmarks to federal and state authorities, ensuring accuracy and compliance with regulations.
Senior Liaison & Care Coordinator
Healthways
Columbia, MD
08.2011 - 08.2012
- Managed complex care coordination initiatives with physicians and support teams to enhance patient outcomes.
- Developed and implemented integrated care plans, streamlining service delivery and reducing redundancies.
- Optimized clinical reporting systems, improving cross-team communication for faster issue resolution.
- Facilitated strategic collaboration to achieve higher quality care at reduced costs.
Medical Services Consultant & Liaison
M Hays
Hunt Valley, MD
04.2009 - 07.2011
- Directed case management strategies to deliver high-quality interventions that enhanced patient outcomes and minimized care costs.
- Collaborated with clients, payers, and providers, leveraging advocacy and planning to improve patient care.
- Executed timely action plans aligned with state guidelines, ensuring compliance while addressing patient needs.
- Built strategic relationships with stakeholders for efficient evaluation and integration of new information.
- Developed cost-effective interventions to enhance recovery and autonomy through resource management.
- Implemented complex case management strategies, driving measurable improvements in care delivery quality.
Site Manager/Clinical Research Coordinator
McGuire VA Research
Fredericksburg, VA
Clinical Research Coordinator
Rx Trials
Fredericksburg, VA
Clinical Research Coordinator
Mary Washington Hospital
Clinical Research Coordinator
University of Virginia, Department of Neurology
Education
Master of Science - Nursing
University of Virginia
Charlottesville, VACharlottesville, VA
Bachelor of Science - Nursing
West Virginia Wesleyan College
Buckhannon, WVBuckhannon, WV
Nurse Coaching Intensive - Nurse Coaching
The Nurse Coach Collective
Nurse Coaching
Legal Nurse Certification Program - Medical-Legal Consulting
Vicki Milazzo Institute
Medical-Legal Consulting
Skills
- Clinical trial management
- Regulatory compliance & documentation
- Project management & strategic planning
- Quality assurance
- Data analysis techniques
- Revenue management & operations
- Cross-functional teamwork & collaboration
- Stakeholder engagement
- Contract & partnership management
- Complex problem-solving skills
- Workforce management strategies
- Microsoft Office & Google Workspace proficiency
- Cloud storage solutions & video conferencing tools
- Clinical trial management systems & databases
Affiliations
• Association of Clinical Research Professionals
• Society of Clinical Research Associates
• National Association of Healthcare Quality
• American Holistic Nurses Association
• Society of Clinical Research Associates
• National Association of Healthcare Quality
• American Holistic Nurses Association
Certification
Registered Nurse (Compact), Commonwealth of Virginia
Volunteer Experience
- COVID drive thru testing and vaccine clinics – affiliation with Mary Washington Healthcare
- Lloyd F. Moss Free Clinic – affiliation with Mary Washington Healthcare
Timeline
Manager of Regulatory & Clinical Documentation
ObjectiveHealth
05.2021 - Current
Site Director
ObjectiveHealth
02.2021 - 05.2021
Telephonic Nurse Case Manager
Paradigm Complex Care Solutions
08.2020 - 02.2021
Supervisor, Special Programs Unit
Paradigm Complex Care Solutions
06.2019 - 05.2020
Quality Improvement Auditor
Paradigm Complex Care Solutions
01.2019 - 06.2019
Manager, Telephonic Case Management
Paradigm Complex Care Solutions
03.2018 - 01.2019
Pharmaceutical Independent Consultant
Cline Consulting, Inc.
01.2015 - 03.2018
Director of Quality Improvement & Risk Management
Spotsylvania Regional Medical Center
08.2012 - 01.2015
Senior Liaison & Care Coordinator
Healthways
08.2011 - 08.2012
Medical Services Consultant & Liaison
M Hays
04.2009 - 07.2011
Site Manager/Clinical Research Coordinator
McGuire VA Research
Clinical Research Coordinator
Rx Trials
Clinical Research Coordinator
Mary Washington Hospital
Clinical Research Coordinator
University of Virginia, Department of Neurology
Master of Science - Nursing
University of Virginia
Bachelor of Science - Nursing
West Virginia Wesleyan College
Nurse Coaching Intensive - Nurse Coaching
The Nurse Coach Collective
Legal Nurse Certification Program - Medical-Legal Consulting
Vicki Milazzo Institute