Lindsey Gonzalez
Burbank,CA
Summary
Detail oriented Senior Clinical Research Associate with a strong background in the Clinical Research industry, spanning over 9 years aspiring to secure a position at Merck. Demonstrated versatility through various roles, including Clinical Research Coordinator and Clinical Research Associate. Proficient in managing studies across all phases, ranging from Phase 0 to Phase IV, with expertise in therapeutic areas such as Vaccine, Neuroscience, Infectious and Respiratory Diseases, Dermatology, Cardiovascular, and Gastroenterology. Skilled in conducting both on-site and remote monitoring visits, including Pre-Site Selection Visits (PSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV). Well-versed in utilizing different clinical and client-specific systems for trial management, including EDC, CTMS, and IVRS.
Overview
9
9
years of professional experience
Work History
Senior Clinical Research Associate
PPD
08.2022 - Current
- Performs and coordinates all aspects of the clinical monitoring and site management process.
- Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
- Manages procedures and guidelines from different sponsors and/or monitoring environments.
- Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.
- Ensures audit readiness. Develops collaborative relationships with investigational sites.
Clinical Research Associate II
ICON/DOCS
10.2021 - 08.2022
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Liaised with clinical project leader to effectively resolve study-related issues.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Conducted site evaluation, initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
Clinical Research Associate I/II
IQVIA
10.2020 - 10.2021
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Ensured drug storage procedures were in compliance with protocols and SOP requirements.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Monitored scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
Clinical Research Coordinator
University Of Texas Southwestern
11.2018 - 10.2020
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Worked with principal investigator and monitors to facilitate daily trial activities and comply with research protocols.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Monitored unit budget to meet financial objectives for spend rate and funding.
- Performed duties in accordance with applicable standards, policies and regulatory guidelines to promote safe working environment.
- Monitored study supply inventory to keep stock levels and databases updated.
Clinical Research Coordinator
University Of Texas Health Science Center
11.2017 - 11.2018
- Obtained/maintained informed consent, study participant education, study enrollment, and data quality management.
- Collected specimens, performed vital signs, reviewed medical history, maintained/created source documentation, and scheduled patients for follow up visits.
- Conducted and documented daily direct observed therapy visits for study participants.
- Frequently reviewed direct observed therapy log for accurate documentation and compliance.
- Maintained electronic binders.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Clinical Research Coordinator
Reliance Clinical Testing Services
08.2015 - 08.2017
- Initiated, managed, and monitored various clinical research projects and provided project specific administrative support.
- Scheduled and participated in monitoring and auditing activities.
- Conducted independent study coordination and screening of potential patients for protocol eligibility.
- Performed Informed Consent process with all consented participants.
- Coordinated laboratory samples and compiled data.
Education
Bachelor of Science - Biology
Texas Woman's University
Denton, TX05.2018
Skills
- 9 years of Site Management experience
- Experience working with multi-functional Project teams
- Knowledge of ICH, and local regulatory authority regulations
- Experience in Monitoring all trials component (PSV, SIV, IMV, and COV)
- Ability to travel (Greater than 70%)
- Excellent attention to details
- Experience working in Phases 0-IV Clinical Trials
- Study Population experience: Pediatrics, Adolescents, and Adults
- Good Clinical Practice
- Time management abilities
- Therapeutic areas of expertise: Vaccine, Neuroscience, Infectious and Respiratory Diseases, Dermatology, Cardiovascular, and Gastroenterology
Languages
Spanish
Native or Bilingual
Timeline
Senior Clinical Research Associate
PPD
08.2022 - Current
Clinical Research Associate II
ICON/DOCS
10.2021 - 08.2022
Clinical Research Associate I/II
IQVIA
10.2020 - 10.2021
Clinical Research Coordinator
University Of Texas Southwestern
11.2018 - 10.2020
Clinical Research Coordinator
University Of Texas Health Science Center
11.2017 - 11.2018
Clinical Research Coordinator
Reliance Clinical Testing Services
08.2015 - 08.2017
Bachelor of Science - Biology
Texas Woman's University