Lauren Collins
Mt. Pleasant,SC
Summary
Versatile certified clinical research professional (CCRP) knowledgeable about all aspects of clinical trial start up, activation, and close out for a diverse clinical trial portfolio. Committed to ensuring compliance with all federal regulations pertaining to human subjects research. Compliance. Highly organized and thorough with excellent planning and problem-solving abilities.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Regulatory Specialist
Winship Cancer Institute, Emory University
Remote
08.2023 - Current
- Submits IND annual reports and amendments to the FDA.
- Coordinates and supports regulatory affairs activities for non-interventional and interventional investigator initiated trials for IRB submission
- Manages new submissions amendments, safety reports, and continuing review activities. Completes protocol renewal applications amendment applications and maintains record of all adverse event reports deviations and review of safety reports.
- Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board IRB policies and procedures and regulations.
Regulatory Manager
Emory University-Winship Cancer Institute
12.2012 - Current
- Recruiting, hiring and trained all regulatory staff, providing direct supervision, ongoing staff development and continuing education to employees
- Leveraged data and analytics to make informed decisions and drive business improvements
- Evaluated employee performance and conveyed constructive feedback to improve skills.
Lead Regulatory Specialist
Medical University Of South Carolina
Charleston, South Carolina
01.2012 - Current
- Develop and direct clinical trial start-up/site activation duties at NCI Designated Cancer Center
- Proficient in complex submission processes of internal and external IRBs to ensure timely study approvals, amendments, annual renewal, adverse event reporting and close out
- Maintain IRB applications and regulatory documents for 90+ active oncology trials
- Proficient in Oncore, eIRB, RAPID, SPARCRequest, Microsoft Word, Powerpoint, Sharepoint
- Enhance and improve new workflows when deficiencies are identified
- Expeditiously disseminate approved study documents to Clinical Operations Team
- Prepare study documents and participate in internal/external audits to ensure compliance with all applicable Federal, State and Local regulations.
Regulatory Assistant
Medical University Of South Carolina
Charleston, South Carolina
03.2012 - 12.2012
- Performed timely and accurate study updates within internal databases, RAPID, and Protocol Review & Monitoring System (PRMS)
- Performed administrative support for Protocol Review and Data Safety Monitoring Committees
- Coordinated large volume of Clinical Research Associate monitoring visits
- Assisted institutional stakeholders with timely submissions of financial and regulatory documents.
Medical Records Supervisor
Charleston GI Specialists
Charleston, South Carolina
08.2009 - 03.2012
- Managed and maintained large volume of medical records for eight physicians in thriving medical practice
- Hired and trained medical record staff.
Education
Bachelor of Science: Sociology -
College of Charleston
Charleston, South Carolina05.2006
Skills
- Good Clinical Practice
- Clinical Trials and Research
- Regulatory Requirements
- Team Development
- Program Management
- Project Management
- Site and Study Management
- Interdepartmental Collaboration
- Staff leadership and supervision
Certification
- Society of Clinical Research Associates – Certified Clinical Research Professional (CCRP)
- South Carolina Clinical & Translational Research Institute – Core Clinical Research Training Certification
- CITI (Collaborative Institutional Training Initiative) Human Subjects Research Curriculum GCP (Good Clinical Practice) Certification
- NIH Certification for Web-based training course “Protecting Human Research Participants”
- Proficient with Microsoft Office and Outlook
- Knowledge of Regulatory Compliance and Research Administration
- Project Management regulations.
Timeline
Regulatory Specialist
Winship Cancer Institute, Emory University
08.2023 - Current
Regulatory Manager
Emory University-Winship Cancer Institute
12.2012 - Current
Regulatory Assistant
Medical University Of South Carolina
03.2012 - 12.2012
Lead Regulatory Specialist
Medical University Of South Carolina
01.2012 - Current
Medical Records Supervisor
Charleston GI Specialists
08.2009 - 03.2012
Bachelor of Science: Sociology -
College of Charleston