Teresa Anna Rodriguez
Chandler,AZ
Summary
Detail-oriented and experienced Sr. Clinical Research Associate seeking to leverage strong organizational skills and comprehensive knowledge of clinical trials to contribute effectively to the research team. Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.
Overview
24
24
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate (Site Manager)
ICON
2022.01 - 2024.01
- Monitored clinical trial sites to ensure adherence to protocols, regulatory requirements, and GCP
- Conducted site initiation, interim monitoring, and closeout visits
- Reviewed and verified source documentation, case report forms (CRFs), and electrical data capture systems (EDC)
- Communicated effectively with investigators, study coordinators, and site staff to address queries and resolve issues promptly
- Prepared and submitted regulatory documents to regulatory authorities and ethics committees
Senior Clinical Research Associate (Site Manager)
Pharmatech
2012.01 - 2022.01
- Managed 8-10 physician offices
- I was responsible for site visits from site selection to close out visits
- Managed clinical trial medicine product and devices
- Managed data collected at sites
- Presented and trained physician and staff on the current study protocol at investigator meetings
- Provided therapeutic education utilizing the study protocol
- Provided education on the central lab system and IVRS systems
- Review informed consent for accuracy
- IP accountability
- CTMS software problem solving
- Maintained business relationships with the clients to ensure a solid foundation for future business
Clinical Research Coordinator
Children’s Hospital
2000.01 - 2012.01
- Facilitated the preparation, review, and submission of regulatory start up documents
- Coordinated PSV/SQV and assist with SIV as needed per site manager request
- Communicated with Research Managers, Marketing and other Site Staff on study start up activities
- Ensured adherence to applicable regulatory requirements, guidelines and Good Clinical Practice (GCP) standards
- Maintained accurate and up-to date study start-up documentation, including tracking systems, databases and study file
- Ensure all subject charts were audit ready
- Obtained Informed consent from study participants
- Communicated with study participants and informed them about study details and expectations
- Collected, documented and managed study data using ALCOA
- Monitor study progress and updated as needed
- Responsible for submitting documents to the sponsor and IRB as needed
- Coordinated and managed clinical trial activities according to protocols and regulatory requirements
- Recruited and screened participants, obtained informed consent, and maintained study records
- Scheduled and facilitated study visits
- Assisted with data collection, entry, and quality control procedures
- Participated in study team meetings and contributed to study progress reports
- Maintained regulatory documents for submission and resubmission after documents have expired
Education
High School Diploma -
Ranum High School
Denver05.1988
Skills
- Proficient in clinical trial protocols and procedures
- Strong understanding of regulatory compliance (FDA)(ICH)
- Excellent communication and interpersonal skills
- Attention to detail
- Ability to maintain accurate records
- Proficiency in Microsoft Office suite
- Proficiency in EDC
- Proficiency in CTMS
Data Management Proficiency
Coordinating site operations
Informed Consent Process
Adverse event reporting
Quality Assurance Techniques
Team Leadership Qualities
Clinical trial management
Vendor Management Experience
Completing regulatory documents
Therapeutic Area Expertise
Site Management
Regulatory Compliance Knowledge
Organizational capabilities
Report Writing
Certification
Good Clinical Practice (GCP) Certification
References
- Linda Morales, Lead manager, 619-862-8862
- Billy Torrez, Study Supervisor, 424-394-4499
Timeline
Senior Clinical Research Associate (Site Manager)
ICON
2022.01 - 2024.01
Senior Clinical Research Associate (Site Manager)
Pharmatech
2012.01 - 2022.01
Clinical Research Coordinator
Children’s Hospital
2000.01 - 2012.01
High School Diploma -
Ranum High School
Good Clinical Practice (GCP) Certification
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