Experience

Viking Therapeutics, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Contractor

  • Sep 2019 - Present



Vital Therapies, Inc.

• Clinical Documentation Specialist

  • Mar 2016 - Present



Ambit Biosciences

• Biotechnology Research
• 1 - 100 Employee

• Sr. Clinical Trail Assistant

  • Jan 2014 - Feb 2016



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Records Management Assistant

  • Mar 2010 - Feb 2012

  • Responsibilities include the coordination and conduct of in-house monitoring activities, review and tracking of regulatory documents, and maintenance for several studies concurrently.• Perform quality control checks of central files in accordance with PAREXEL Standard Operating Procedures (SOP) and operational guidelines.• Collect and maintain master site files, conduct internal file audits, and prepare study files for sponsor audits.• Communicate with site staff to resolve pending file audit issues.• Track and distribute IND Safety Reports to site investigators and Central IRBs.• Participate in project meetings and generate weekly and monthly reports for sponsor and team members.• Provide direct support to Project Management, Clinical Research Associates, sponsors, and site investigators to ensure adherence to Good Clinical Practices and FDA regulations Show less

• Clinical Research Assistant

  • Jun 2007 - Feb 2010

  • Communicated with sites directly to support them whenever necessary• Coordinated and conducted in-house monitoring activities, review and tracking of regulatory documents, and database setup and maintenance for Phase I-IV clinical trials.• Performed all IRB submissions for the sites using the central IRB.• Performed revisions/edits on Informed Consent documents when necessary and sent to the Clinical Lead for approval before sending on to the IRB• Collected all documents necessary to submit updated SRP’s for approval• Collected and maintained master site files, track investigator and IRB payments, record meeting minutes for study team meetings.• Track and distribute IND Safety Reports to site investigators and Central IRBs.• Performed quality control checks of central files in accordance with PAREXEL and sponsor SOP and operational guidelines.• Maintained study spreadsheets and generate weekly and monthly reports for sponsor and team members. Show less



Covance

• United States
• Research Services
• 700 & Above Employee

• Regulatory Document Specialist

  • Jan 2003 - Mar 2007

  • Responsibilities included the preparation of study specific documents for IRB submissions and tracked the status of pending protocols for IRB review. • Submitted initial protocol, Investigator Brochure, Informed Consents and any revisions throughout the course of the study. • Submitted all study related recruitment materials to the sponsor and IRB for review and approval. • Oversaw the tracking and reporting of all Serious Adverse Events to the IRB and sponsor. • Tracked, prepared, and submitted interim reports and final summaries to the IRB describing study activity. • Oversaw the preparation of all closed study files for archiving in long term storage. • Filed and maintained all critical documents related to study conduct. Show less



Accelerated Enrollment Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• DEXA Technician / Research Assistant

  • Jan 1995 - Jan 2003

  • Responsibilities included performing study related procedures such as DEXA scan testing and Pulmonary Function Testing (PFTs) as required by clinical study protocols. • Prepared and maintained critical study documents for DEXA and PFTs for each study participant. • Conducted the completion of all study document forms, including case report forms and study specific documentation. • Assisted late phase study coordinators with the conduct and completion of scheduled study visits when needed. • Assisted in conducting patient care visit and assured all procedures were conducted in compliance with the clinical protocol. Show less



San Diego Endocrine & Medical Clinic

• DXA Tech

  • 1997 - 2003

  Greeted study participants and performed the scan according to protocol. Analyzed or compared to previous scan. Greeted study participants and performed the scan according to protocol. Analyzed or compared to previous scan.



Dr. Weiss/Radiant Research

• Regulatory Coordinator

  • 1995 - 2001

• Regulatory Coordinator

  • 1995 - 2001

  Collect, file, update and maintain all Regulatory Files, Work with IRBs on submissions, ongoing reporting, final reports for study close out. Schedule CRAs for interim monitoring visits, maintain all Site Trail Files for review readiness. Performed Bone Density Scans and Pulmonary Testing for Clinical Trails that were ongoing at the site.