Lucy Rems
Corona
Summary
A Quality Assurance Manager with over 28 years of experience in the clinical research industry, focusing on upholding high standards of data collection and maintaining subject safety. Adherence to study protocols, SOPs, ICH GCP guidelines, IRB guidelines, and code of Federal Regulations, data verification, process improvement, training, and enhancing the company.
Overview
28
28
years of professional experience
1
1
Certification
Work History
Quality Assurance Manager
Advanced Clinical Research Institute
06.2005 - Current
- Ensure site compliance with the study protocol, SOPs, GCP, ICH guidelines and Federal regulations
- Supervise a team of 7 Quality Assurance Associates
- Provide training and education to clinical staff on site SOPs, GCP, and federal regulations as appropriate
- Develop, manage, and implement quality control strategies and initiatives
- Developed and executed successful internal quality audits for continuous process improvement and risk mitigation.
- Review of subject research charts as appropriate to ensure compliance with the consenting process and protocol procedures
- Review of protocol deviations for trend analysis
- Identify and record non-conformances using site SOPs
- Review all study monitor follow up letters to ensure all issues get resolved in a timely manner
- Assist clinical research staff in preparing for a sponsor/CRO or regulatory inspection
- Host sponsor/CRO or regulatory inspection as applicable
- In collaboration with the clinical operations staff, develop and/or revise standard operating procedures
Certified Clinical Research Coordinator
Advanced Clinical Research Institute
02.1998 - 05.2005
- Managed Phase I-IV trials from initial sponsor contact for site selection, through study preparation, study coordination, and study completion
- Directed a satellite research site for company from 2001 – 2004.
- Improved clinical trial efficiency by streamlining processes and implementing new data management systems.
- Reduced study timelines through effective communication and collaboration with cross-functional teams.
- Assist the Executive Director in the review of clinical research project proposals from sponsors and determine whether the clinical study is logistically feasible for the site
- Review of medical records for study eligibility
- Attend administrative meetings as needed
- Assist in the development and review of SOPs and SWPs, organize SOP meeting annually
- Provide coverage for clinical research coordinators, research assistants and/or front desk
- Act as primary CRC or back-up CRC in clinical research studies assigned as needed
Clinical Research Coordinator
Sall Eye Surgery Center
10.1995 - 02.1998
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Streamlined data collection processes for increased efficiency and accuracy in study results.
- Conducted Informed Consent Procedures according to site SOP’s FDA regulations and HIPPA requirements
- Dispensed, administered and monitored oral and topical medications in the research department as per sponsor protocol
- Maintained trial drug inventory and performed trial drug accountability
- Completed and maintained reports, site correspondence, telephone logs and other relevant documents
- Alerted investigator to any adverse events and lab abnormalities
- Alerted and reviewed Serious Adverse Events in a timely manner to Principal Investigator, Monitor, Sponsor and IRB
- Acted as primary liaison between investigator, ancillary departments, patients, sponsor company and regulating bodies
Education
Associate of Arts - Social And Behavioral Studies
Norco College
Norco, CA12.2022
Training
CITI Course - Protection of Human Research Subjects, 07/01/10 Advanced GCP Compliance, Barnett International, 09/01/06 Quality Monitoring Seminar, Medical Research Management, 12/01/05 HIPAA, Homestead Schools, Inc., 05/01/05 American Diabetes Association Educational Conference, 10/01/04
Certification
- Society of Quality Assurance
- Regulatory Affairs Professionals Society
- Certified Clinical Research Coordinator - ACRP
- Good Clinical Practice - CITI Training
- Phlebotomy (Tech 1) -CA Department of Health
- Certified Quality Auditor, ASQ, CQA
- Transportation of Dangerous Goods
Timeline
Quality Assurance Manager
Advanced Clinical Research Institute
06.2005 - Current
Certified Clinical Research Coordinator
Advanced Clinical Research Institute
02.1998 - 05.2005
Clinical Research Coordinator
Sall Eye Surgery Center
10.1995 - 02.1998
Associate of Arts - Social And Behavioral Studies
Norco College
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