LinkedInCarol Youngdahl, CCRA

Carol Youngdahl, CCRA

Sr. CRA at Covance

Location
Erie, Pennsylvania Area
Industry
Research
Previous
  1. American Medical Systems,
  2. J Tyson & Associates,
  3. Safe Harbor Behavioral Health
Education
  1. Gannon University
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Gannon University

Gannon University

Health Administration

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Background

Summary

Sr. CRA with experience monitoring cardiac, peripheral vascular disease, spinal,and pelvic support device/drug studies. Proficient in electronic data capture systems. Travel has included the East Coast to Mid West regions and select cities on the West Coast of the United States.

Specialties:
- Lead CRA experience, including CRA training and development, site scheduling, trending, study metrics, monitoring plan development
- Skilled in Site Initiation, Interim Monitoring and Closure visits
- Excellent report writing skills
- Self-motivated to complete projects and tasks independently
- Adept at identifying site problems/issues and working to resolve them with site staff
- Able to develop productive working relationships with site personnel
- Well-developed organizational skills
- Knowledgeable in GCP and regulatory guidelines
- Detail oriented

Experience

Sr. CRA

Covance
– Present (1 year 5 months)

Sr. Field Clinical Research Specialist

American Medical Systems
(2 years 1 month)Minnetonka, MN

• Act as Lead CRA
• Monitor assigned sites
• Professional Development:
- Drove process for adopting a naming convention for study documents and developed a corresponding guidance document
- Developed a guidance document for using the OHRP Website and provided training to FCRS group
- Provided a teach-back training on an ACRP article, “Common GCP Violations and Site Mistakes and How to Avoid Them”

Sr. CRA

J Tyson & Associates
(1 year 9 months)Silver Lake, WI

Conduct interim monitoring and site close-out visits; complete visit reports within SOP timeframe; complete 100% SDV through review of site source documents and eCRFs; ensure reporting of all adverse events and protocol deviations per protocol; complete device and/or drug accountability per review of logs and product used/on hand; ensure query resolution; ensure quality work by following GCP and regulatory guidelines, as well as CRO SOPs; provide training to new CRAs through co-monitoring visits.

CRA

J Tyson & Associates
(3 years 2 months)Silver Lake, WI

Conduct interim monitoring visits; complete visit reports within SOP timeframe; monitor eCRFs against source documents to ensure accuracy of data; ensure all adverse events and protocol deviations are reported to sponsor and IRB per protocol; ensure that GCP and regulatory guidelines are followed at each assigned site; ensure device/drug accountability is accurate through review of logs and device/drug used and on hand; facilitate query resolution; provide protocol and EDC training for site staff.

Corporate Compliance Officer

Safe Harbor Behavioral Health
(3 years 4 months)Erie, PA

Developed and implemented agency-wide Compliance Program, including HIPAA Privacy and Security; developed and presented new employee orientation program to satisfy regulatory requirements; Drove process and ensured regulatory compliance for development of a Drug and Alcohol Program, including interacting with PA board of D&A program officials; established medical chart and billing audit program

Compliance Coordinator and Auditor

Joint Ventures
(3 years 8 months)Erie, PA

Facilitated the implementation of compliance programs for six Joint Venture organizations; conducted compliance audits and verified completion of corrective actions resulting from compliance with all federal, state and other regulatory agencies

Skills

  • GCP
  • EDC
  • Clinical
  • Hospitals
  • Medical Devices
  • Regulatory Affairs
  • CTMS
  • Clinical Research
  • Clinical Development
  • Urology
  • Clinical Monitoring
  • Biotechnology
  • FDA
  • Clinical Trials
  • Protocol
  • Medical Writing
  • Oncology
  • Regulatory Requirements
  • Clinical Data Management
  • ISO 13485
  • Sop
  • IRB
  • CRO
  • Clinical Study Design
  • Cardiology
  • See 10+  See less

Education

MRM, Fundamentals of Clinical Research Monitoring

Organizations

MRM, ACRP

Honors & Awards

CCRA, ACRP, 2011
Financial Awareness Award, JTA, March, 2011
Road Warrior Award, JTA, March, 2011
Above & Beyond Award, JTA, February, 2010

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