Carmen Grcich is a high-level professional, working in Dynavax Technologies main office of which is in 1178. on the position of Clinical Quality Consultant since 2015. Carmen has earned professional experience in more than 29 positions at different companies. Carmen Grcich went to the University of Missouri - Columbia and received education. San Francisco, California is the area, where this person was known to be situated. Their email address and phone number can be easily accessed through SoftwareOfficial on demand.
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Carmen Grcich
Last updated Jun 27, 2024
Contact Information
Workplace
Colleagues
Work History
Clinical Quality Consultant
2100 Powell St SUITE 900, Emeryville, CA 94608
2015 — 2015
Clinical Research Consultant
740 Bay Rd, Redwood City, CA 94063
Assisted with overall management of a cardiovascular device IDE study. Managed Clinical Events Committee by reviewing cumulative events listings, providing committee with events for adjudica...
from Feb 2014
Clinical Research Consultant
Illinois
Wrote and/or revised the full complement of clinical operations SOPs/DOPs for global use, in conjunction with clinical team members. Conducted internal study audits in preparation for FDA i...
2007 — 2014
Clinical Research Consultant
Conducted European clinical site GCP compliance audits and CRO audit for global trial of cardiovascular medical device. Conducted audits of US CRO and clinical site for IDE trial.
from 2013
Clinical Research Consultant
9708 Medical Center Dr, Rockville, MD 20850
Monitored Phase I, II and III trials
participated in protocol and CRF development
reviewed clinical monitoring reports
co-monitored clinical sites with CRO monitors
performed overall si...
from 2009
Clinical Research Consultant
249 east Grand Ave, South San Francisco, CA 94080
Wrote/revised clinical operations SOPs in concert with the clinical operations team.
2008 — 2008
Clinical Research Consultant
Wrote/revised SOPs for clinical operations Served as an unblinded pharmacy monitor.
2002 — 2007
Clinical Research Consultant
100 Boston Scientific Way, Marlborough, MA 01752
Conducted trial master file audits
trained junior members of the clinical team on GCP and SOPs/DOPs
performed pre-FDA inspection preparation and supported team during audits.
2002 — 2007
Clinical Research Consultant
24590 Clawiter Rd, Hayward, CA 94545
Wrote/revised SOPs for clinical operations.
2006 — 2006
Clinical Research Consultant
Performed clinical monitoring, site management, and auditing of site regulatory documents and data for oncology studies.
2005 — 2006
Clinical Research Consultant
Assisted in protocol development, vendor management, monitoring report review and SOP development.
2004 — 2005
Clinical Research Consultant
Illinois
Tracked down missing data and compiled results for a multi-center ophthalmic study. Developed a humanitarian use device protocol and informed consent form.
2004 — 2005
Clinical Research Consultant
1 Amgen Center Dr, Thousand Oaks, CA 91320
Subject matter expert reviewing video GCP training and providing input. Created SOP training presentations for online viewing by the clinical operations team.
2004 — 2005
Clinical Research Consultant
1 Dna Way, South San Francisco, CA 94080
Clinical Trial Manager for large, multi-center Phase IV breast cancer study.
2002 — 2005
Clinical Research Consultant
Developed protocol and CRFs, conducted site training, and performed overall clinical project management for an investigator sponsored trial in non-Hodgkins lymphoma.
2002 — 2004
Clinical Research Consultant
Conducted audits of sponsor trial master files. Conducted co-monitoring visits to clinical sites.
2004 — 2004
Clinical Research Consultant
14200 Shady Grove Rd, Rockville, MD 20850
Responsible for site management and clinical monitoring for a mucositis/bone marrow transplant study.
2000 — 2002
Clinical Research Consultant
Provided subject matter expertise for development of clinical trial subject recruitment database.
2001 — 2002
Clinical Research Consultant
Conducted audits of the clinical trial master files
researched, made proposals to management, and implemented new central filing system
developed/revised clinical operations SOPs
support...
2000 — 2001
Clinical Research Consultant
Developed templates for clinical trial use including monitoring visit reports and device accountability records for cardiovascular device studies.
2001 — 2001
Clinical Research Consultant
Conducted clinical site audits for blood glucose monitoring medical device.
1999 — 2000
Clinical Research Consultant
Managed time-critical data transfers from European sites to US based central labs and vendors to meet study completion timelines for cardiovascular device trial
interfaced with key Europea...
1997 — 2000
Clinical Research Consultant
Conducted data reviews of critical study endpoints
conducted trial master file audits
conducted site GCP compliance audits and pre-FDA inspection audits
trained staff on GCPs and SOPs/DO...
1995 — 2000
Clinical Research Consultant
3280 Bayshore Blvd, Brisbane, CA 94005
Performed monitoring and data cleanup of investigator sponsored study for submission of orphan drug indication; wrote clinical summaries of adverse events.
1999 — 1999
Clinical Research Consultant
Performed site management and clinical monitoring for gene therapy used in the treatment of glioblastoma multiforme.
1995 — 1997
Clinical Research Consultant
Conducted audits of trial master files for ophthalmic biologic.
1994 — 1995
Senior Clinical Research Associate
275 Grove St SUITE 101C, Newton, MA 02466
Primary CRA large multi-center AIDS trial. Served on Training Steering Committee and Mentor Task Force. Mentored junior team members by accompanying on monitoring visits. Wrote patient summa...
1992 — 1993
Senior Cra
Involved in all facets of clinical trial management including protocol and CRF design, drug packaging and randomization, site management and monitoring, and final report writing.
1985 — 1992
Education
Occupations
Executive
Owner
Counselor
Chief Executive
Advisor
Skills
Gcp
Ctms
Clinical Trials
Clinical Research
Fda
Clinical Monitoring
Oncology
Clinical Development
Cro
Ich Gcp
Pharmaceutical Industry
Medical Devices
Edc
Regulatory Affairs
Medical Writing
Protocol
Clinical Operations
Cardiology
Sop
U.s. Food and Drug Administration
Biotechnology
Good Clinical Practice
Clinical Trial Management System
Dermatology
Regulatory Submissions
Standard Operating Procedure
Diabetes
Neurology
Cro Management
Infectious Diseases
Drug Development
Clinical Data Management
21 Cfr Part 11
Biopharmaceuticals
Clinical Study Design
Research
Pharmacovigilance
Therapeutic Areas
Lifesciences
Validation
Ind
Ophthalmology
Immunology
Drug Testing
FAQs about Carmen Grcich
What is the main profession of Carmen Grcich?
Carmen Grcich is a Owner.
What jobs is Carmen Grcich proficient at at?
Carmen is proficient at such jobs as Executive and Owner.
Where is Carmen Grcich located?
Carmen Grcich is located in San Francisco, California.
Where did Carmen Grcich work?
Carmen Grcich worked at Dynavax Technologies, Arstasis.
Where has Carmen Grcich studied?
Carmen studied at the University of Missouri - Columbia.
What is professional industry that Carmen Grcich worked in?
Carmen works in Pharmaceuticals industry.
What are the skills of Carmen Grcich?
Carmen Grcich has skills in the following areas: Gcp, Ctms, Clinical Trials, Clinical Research, Fda, Clinical Monitoring, Oncology, Clinical Development, Cro, Ich Gcp, Pharmaceutical Industry, Medical Devices, and Edc.