Open To Work
Natasha Ruffing
Pottstown,PA
Summary
Operations, compliance, and project coordination professional with more than 20 years of experience leading initiatives in highly regulate healthcare and clinical research environments. Experienced managing multiple concurrent projects, coordinating cross-functional team, tracking milestones, mitigation risks, improving processes, and maintaining high quality, documentation. Recognized for strong organization, communication, and the ability to deliver results in fast-paced environments. Trusted to facilitate meetings, interpret procedures, and maintain accountability in highly regulated environments.
Detail-oriented individual with exceptional communication and project management skills. Proven ability to handle multiple tasks effectively and efficiently in fast-paced environments. Recognized for taking proactive approach to identifying and addressing issues, with focus on optimizing processes and supporting team objectives.
Overview
17
17
years of professional experience
Work History
TMF Lead II
Syneos Health
10.2021 - 03.2026
- Managed Trial Master Files for five global clinical studies while partnering with project managers, sponsors, quality assurance, and cross-functional teams.
- Presented compliance metrics and facilitated monthly meetings focused on quality, completeness, accountability, and inspection readiness.
- Trained and coached study teams on documentation standards, regulatory expectations, and company procedures.
- Served as a trusted resource for process interpretation, issue resolution, and continuous improvement initiatives.
- Led complex remediation efforts including a study containing over 50,000 documents and coordinated successful TMF transfers to sponsors.
- Supported sponsor audits, internal audits, and mock inspections while maintaining inspection-ready documentation.
- Managed highly confidential business records with exceptional discretion and attention to detail.
- Excellent communication skills, both verbal and written.
- Worked effectively in fast-paced environments.
TMF Specialist III
ICON Clinical Research
08.2012 - 06.2020
- Served as department subject matter expert for electronic Trial Master File systems and documentation procedures.
- Progressed from Assistant Mentor to Lead Mentor, serving approximately six years as Lead Mentor.
- Mentored, trained, and onboarded approximately 50 employees through one-on-one coaching and performance support.
- Developed training materials, job aids, presentations, and departmental reference documents.
- Facilitated monthly educational forums and served as the primary resource for employee questions.
- Managed shared workflow and partnered with leadership to improve SOPs, work instructions, and departmental processes.
- Prepared reports, analyzed quality trends, and recommended process improvements that strengthened compliance.
Compliance Officer / Scheduling Coordinator
Visiting Nurses of Pottstown and Vicinity
04.2009 - 08.2012
- Managed dual responsibilities by supporting compliance initiatives and coordinating clinical staff scheduling.
- Upheld integrity of confidential employee and patient records following healthcare regulations.
- Collaborated with leadership to address staffing challenges and enhance operational efficiency.
- Facilitated compliance documentation accuracy and enhanced workflow efficiency.
- Engaged with employee engagement committee facilitating planning of activities aimed at boosting employee appreciation and morale.
- Oversaw compliance with federal and state regulations to guarantee organizational adherence.
- Managed 50 calls per day. Communicating between patients, healthcare providers, and support staff efficiently.
Education
Certificate - Google Project Management
Coursera
Online07-2026
Certificate - Medical Assisting
Lincoln Technical Institute
Allentown, PA2004
Skills
- Project Coordination
- Project Lifecycle Support
- Stakeholder Communication
- Policy & Procedure Administration
- Regulatory Compliance
- Change Management
- Documentation Management
- Meeting Coordination and Minutes
- Process Improvement
- Cross-Functional Collaboration
- Leadership
- Audit Readiness
- Microsoft Office
- Smartsheet
- Veeva Vault
- Communication
Timeline
TMF Lead II
Syneos Health
10.2021 - 03.2026
TMF Specialist III
ICON Clinical Research
08.2012 - 06.2020
Compliance Officer / Scheduling Coordinator
Visiting Nurses of Pottstown and Vicinity
04.2009 - 08.2012
Certificate - Google Project Management
Coursera
Certificate - Medical Assisting
Lincoln Technical Institute
CAREER HIGHLIGHTS
- Promoted into leadership roles based on technical expertise, mentoring ability, and trusted judgment.
- Mentored and trained approximately 50 employees during eight years at ICON, including six years as Lead Mentor.
- Managed Trial Master File operations across five global clinical studies while partnering with sponsors, project managers, and quality teams.
- Presented compliance metrics, facilitated action-planning meetings, and drove inspection readiness initiatives.
- Led major TMF remediation and sponsor transfer projects requiring collaboration across multiple departments.
- Served simultaneously as Compliance Officer and Scheduling Coordinator, balancing staffing, compliance, and employee support responsibilities.
- Selected to serve on an Employee Engagement Committee responsible for planning employee appreciation and morale-building events.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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PROFESSIONAL STRENGTHS
- Trusted to handle confidential and sensitive information with professionalism.
- Recognized for mentoring employees and building strong working relationships.
- Experienced in highly regulated environments where compliance, accountability, and documentation are critical.
- Known for taking initiative, solving problems, and maintaining composure under pressure.