Experience

Advanced Clinical

• United States
• Biotechnology Research
• 700 & Above Employee

• Clinical Research Associate

  • Apr 2021 - Mar 2023

  Responsible for all aspects of study site monitoring including site qualification visits, pre-study visits, site initiation visits, routine monitoring visits, and close-out visits of clinical sites. Ensures the protection of study subjects by verifying that informed consent procedures have been followed and protocol requirements are adhered to according to applicable regulatory requirements. Monitors, tracks, and follows up on all Adverse Events (AEs) and Serious Adverse Events (SAEs)… Show more Responsible for all aspects of study site monitoring including site qualification visits, pre-study visits, site initiation visits, routine monitoring visits, and close-out visits of clinical sites. Ensures the protection of study subjects by verifying that informed consent procedures have been followed and protocol requirements are adhered to according to applicable regulatory requirements. Monitors, tracks, and follows up on all Adverse Events (AEs) and Serious Adverse Events (SAEs). Ensures all SAEs are reported to sponsor and regulatory authorities within required timelines. Ensures the accuracy and integrity of the data submitted on electronic or paper Case Report Forms (CRFs) or other data collection tools by comprehensive source document review. Monitors data for missing or discrepant data. Ensures all required monitoring tasks are conducted according to SOPs, established guidelines, work instructions (WIs), monitoring plans, and project plans. Conducts eCRF/CRF review, query generation, and resolution against established data review guidelines. Assists with feasibility collection and general collection of investigator regulatory documents. Creates spreadsheets or other tracking tools used to update and track study milestones and progress. Attends investigators or site initiation meetings, project team meetings, and teleconferences, as needed. Understands and applies knowledge regarding local, state, and country regulations and industry guidelines, e.g., HIPAA, CA Bill of Rights, International Conference on Harmonization (ICH), and Good Clinical Practices (GCP's). Working knowledge of electronic systems e.g., e-CRF, electronic Trial File Master (e-TMF), and Clinical Trial Management System (CTMS).

• Clinical Research Associate II

  • May 2019 - Apr 2021

  Responsible for all aspects of study site monitoring including site qualification visits, pre-study visits, site initiation visits, routine monitoring visits, and close-out visits of clinical sites. Ensured the protection of study subjects by verifying that informed consent procedures have been followed and protocol requirements are adhered to according to applicable regulatory requirements. Monitored, tracked, and followed up on all Adverse Events (AEs) and Serious Adverse Events (SAEs).… Show more Responsible for all aspects of study site monitoring including site qualification visits, pre-study visits, site initiation visits, routine monitoring visits, and close-out visits of clinical sites. Ensured the protection of study subjects by verifying that informed consent procedures have been followed and protocol requirements are adhered to according to applicable regulatory requirements. Monitored, tracked, and followed up on all Adverse Events (AEs) and Serious Adverse Events (SAEs). Ensured all SAEs are reported to sponsor and regulatory authorities within required timelines. Ensured the accuracy and integrity of the data submitted on electronic or paper Case Report Forms (CRFs) or other data collection tools by comprehensive source document review. Monitored data for missing or discrepant data. Ensured all required monitoring tasks are conducted according to SOPs, established guidelines, work instructions (WIs), monitoring plans, and project plans. Conducted eCRF/CRF review, query generation, and resolution against established data review guidelines. Assisted with feasibility collection and general collection of investigator regulatory documents. Created spreadsheets or other tracking tools used to update and track study milestones and progress. Attended investigators or site initiation meetings, project team meetings, and teleconferences, as needed. Applied knowledge regarding local, state, and country regulations and industry guidelines, e.g., HIPAA, CA Bill of Rights, International Conference on Harmonization (ICH), and Good Clinical Practices (GCP's). Working knowledge of electronic systems e.g., e-CRF, electronic Trial File Master (e-TMF), and Clinical Trial Management System (CTMS). Attended all required training, study-specific training, and assisting in training of other co-workers.



Covance (Labcorp)

• Columbus, Ohio, United States

• Clinical Research Associate I

  • Feb 2017 - May 2019

  Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations. Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion. Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance. Maintained site monitoring schedules to facilitate effective communication with members of… Show more Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations. Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion. Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance. Maintained site monitoring schedules to facilitate effective communication with members of clinical team. Conducted clinical trial in accordance with protocol and recorded and monitored progress. Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality. Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues. Show less Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations. Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion. Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance. Maintained site monitoring schedules to facilitate effective communication with members of… Show more Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations. Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion. Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance. Maintained site monitoring schedules to facilitate effective communication with members of clinical team. Conducted clinical trial in accordance with protocol and recorded and monitored progress. Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality. Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues. Show less