Martha Arredondo
Houston,TX
Summary
Results-driven Senior Clinical Research Associate with expertise in clinical trial management, adverse event reporting, and monitoring visits. Proven ability to enhance participant safety and ensure compliance with GCP standards.
Overview
12
12
years of professional experience
Work History
Senior Clinical Research Associate
Baylor College Of Medicine
07.2021 - Current
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
Senior Clinical Research Associate
Baylor College Of Medicine
09.2016 - 07.2021
- Provided expert guidance to junior team members, fostering a culture of continuous learning and professional growth.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
- Designed effective training materials for site personnel, enhancing understanding of study procedures and expectations.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Followed informed consent processes and maintained records.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Reviewed referral information and kept track of intakes from various referral sources.
Research Interviewer
MD Anderson Cancer Center
03.2014 - 09.2016
- Conducted interviews with participants to assess eligibility.
- Coded data from participant interviews.
- Effectively managed time, balancing multiple projects simultaneously while maintaining strict deadlines and quality standards.
- Enhanced data accuracy by meticulously conducting in-depth interviews with research participants.
- Ensured high-quality data collection by closely adhering to established protocols and guidelines.
- Participated in ongoing training sessions, staying up-to-date on best practices for effective interviewing techniques within the field of research.
- Recorded customer survey answers verbatim to achieve 100% accurate reporting.
- Conducted telephone interviews of the general population to collect data for [Type] studies.
- Collected and recorded data at various field sites for later assessment and data analysis.
Education
Bachelor of Arts - Interdisciplinary Studies
Vanderbilt University
Nashville05-2012
Skills
- Data management proficiency
- Coordinating site operations
- Adverse event reporting
- Clinical trial management
- ICH-gCP guidelines
- Monitoring visits
- Electronic data capture systems
- Reviewing data standards
- Study protocols
- Good clinical practices
- Research sops understanding
- Specimen handling
- Trial management
- Report preparation
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Timeline
Senior Clinical Research Associate
Baylor College Of Medicine
07.2021 - Current
Senior Clinical Research Associate
Baylor College Of Medicine
09.2016 - 07.2021
Research Interviewer
MD Anderson Cancer Center
03.2014 - 09.2016
Bachelor of Arts - Interdisciplinary Studies
Vanderbilt University
Publications
Hill, LaQuisa C et al. “Antitumor efficacy and safety of unedited autologous CD5.CAR T cells in relapsed/refractory mature T-cell lymphomas.” Blood vol. 143,13 (2024): 1231-1241. doi:10.1182/blood.2023022204