Sibi R. Mathew
Pearland,TX
Summary
Highly self-motivated and goal-oriented professional committed to pursuing a long-term career in an academic/biotech/pharmaceutical institution utilizing my expertise in clinical research processes. Offers twenty years of experience in clinical research demonstrating strong analytical and problem-solving skills in monitoring clinical research protocols
Overview
23
23
years of professional experience
Work History
CLINICAL RESEARCH MONITOR II
UTHealth
Houston, TX
08.2011 - 07.2025
- Conducts Site Initiation Visits, Interim Monitoring Visits, and Closeout Visits
- Verifies source documentation, reviews protocol adherence, data corrections/query resolution.
- Performs quality data review of the electronic case report forms (eCRF) onsite and remotely Develops and modifies study-specific monitoring plans, standard operating procedures (SOPs), eCRFs, monitoring tools, and monitoring reports.
- Attends discussions in regards to protocol development at Steering Committee and Executive Committee/Principal Investigator conference calls.
- Assists coordinators on protocol questions & facilitates regulatory document maintenance Contributed as first author in a Cardiovascular Cell Therapy Research Network publication
- CCTRN PUBLICATION: Sibi R. Mathew, Kristen D. Lucas, Shelly L. Sayre, Judy Bettencourt, Tina Collins, Dana Leach, Rachel E. Olson, Doris A. Taylor, and Lemuel A. Moyé for the Cardiovascular Cell Therapy Research Network (CCTRN). Clinical Monitoring in a Federally Funded Environment: Evolution and Opportunities in the Cardiovascular Cell Therapy Research Network. The Monitor. 2014 Feb: 31-36. PMID: PMC4308686
- UTHealth IRB: Committee for the Protection of Human Subjects (CPHS) Sep 2022-July 2025
DATA ANALYST
University of Texas M.D. Anderson Cancer Center
Houston, TX
09.2008 - 11.2009
SENIOR CRA
INC Research
Houston, TX
09.2006 - 06.2008
CLINICAL RESEARCH ASSOCIATE (CRA II)
PAREXEL International
Houston, TX
04.2005 - 08.2006
CLINICAL RESEARCH ASSOCIATE (CRA I/II)
PPD Development
Austin, TX
07.2002 - 03.2005
- Summary of former employment: Conducted Pre-Study, Initiation, Interim Monitoring, and Closeout Visits on Phase II, III, and IV Studies Trained coordinators on CRF guidelines, drug accountability, regulatory document maintenance, and query resolution. Participated in data transfers and database locks and composing audit reports of site visit findings.
Education
Bachelor of Science - Biochemical & Biophysical Sciences, Psychology
University of Houston College of Natural Sciences and Mathematics
Master of Science - Clinical Research Organization and Management (CROM)
Drexel University College of Medicine Graduate School of Biomedical Sciences & Professional Studies
08.2021
Skills
Data Analysis
Protocol adherence
Regulatory Compliance
Safety Reporting
Languages
English
Professional Working
THERAPEUTIC EXPERIENCE
- Arthritis: Rheumatoid, Osteoarthritis
- Anesthesiology & Pain: PONV (Postoperative/Opioid)
- Cardiology Cardiovascular Cell Therapy
- Dental - ICDAS Dental Assessment Form Review
- Dermatology: Psoriasis
- Neurology: Multiple Sclerosis, Epilepsy
- Oncology: Osteosarcoma, Retinoblastoma
- Urology: Urinary Incontinence
PROFESSIONAL DEVELOPMENT
- CITI Program-Human Research Group 1 Biomedical Researcher and Key Personnel Refresher Course-Expires Feb-2027
- CITI Program-Good Clinical Practice-Expires Sep-2027
Timeline
CLINICAL RESEARCH MONITOR II
UTHealth
08.2011 - 07.2025
DATA ANALYST
University of Texas M.D. Anderson Cancer Center
09.2008 - 11.2009
SENIOR CRA
INC Research
09.2006 - 06.2008
CLINICAL RESEARCH ASSOCIATE (CRA II)
PAREXEL International
04.2005 - 08.2006
CLINICAL RESEARCH ASSOCIATE (CRA I/II)
PPD Development
07.2002 - 03.2005
Bachelor of Science - Biochemical & Biophysical Sciences, Psychology
University of Houston College of Natural Sciences and Mathematics
Master of Science - Clinical Research Organization and Management (CROM)
Drexel University College of Medicine Graduate School of Biomedical Sciences & Professional Studies