Clinical Research Associate II at ICON plc (2025-05 – 2025-09)
- Clinical on-site monitoring of Phase III trials for Fabry Disease, Pompe Disease, and Atopic Dermatitis for Sanofi
- Site Management of site issues
- Maintained Xcellerate XRIM and CTMS systems with all monitoring activities, findings, updates, and resolutions
- Maintained study trackers for internal record keeping, site updates, compliance, and thorough study completion
- Ensure site staff training for ICH/GCP, IATA, EDC, RBM, and protocol-specific training with documentation
- Use of Electronic Medical Records Systems, EDC data entry and query resolution, Trial Master File, and CTMS
- On-Site Routine Monitoring Visits
- Site Communication: Scheduling Site Visits, interim study activities, sending and confirming filing of Confirmation and Follow-Up Monitoring Letters
- Managed investigational product accountability at the site level, including storage, dispensing, reconciliation, and return/disposal processes
- Provided training on protocol requirements, study procedures, and data collection tools to site staff members
- Monitored adverse events reported by study participants or identified during site visits; promptly communicated findings to the sponsor
- Maintained comprehensive documentation of all monitoring activities in accordance with company SOPs and regulatory guidelines
- Assisted in the preparation of regulatory submissions for ethics committees/institutional review boards (IRBs)
- Ensured compliance with local regulations regarding informed consent process; reviewed informed consent forms for clarity and completeness
- Coordinated resolution of queries raised during data cleaning/validation process between sites/study team/central laboratory/vendors as needed
Senior In-House Clinical Research Associate at Fortrea (formerly Covance & LabCorp) (2023-07 – 2024-11)
- Clinical monitoring of Phase I-IV trials for Sponsors including AstraZeneca, FATE Therapeutics, Autifony, Alumis, and Bristol Myers Squibb
- Provide CRO oversight for Site Study Start-Up and Study Maintenance
- Site Management of site issues
- Ensure site staff training for ICH/GCP, IATA, EDC, RBM, and protocol-specific training with documentation
- Use of Electronic Medical Records Systems, EDC data entry and query resolution, Trial Master File, and CTMS
- Remote Site Selection, Remote Site Initiation Visits, Remote Routine Monitoring Visits, Remote Close-Out Visit conduct
- Site communication, Visit (Trip) Reporting, and Follow-Up Letters
- Managed investigational product accountability at the site level, including storage, dispensing, reconciliation, and return/disposal processes
- Provided training on protocol requirements, study procedures, and data collection tools to site staff members
- Monitored adverse events reported by study participants or identified during site visits; promptly communicated findings to the sponsor
- Maintained comprehensive documentation of all monitoring activities in accordance with company SOPs and regulatory guidelines
- Assisted in the preparation of regulatory submissions for ethics committees/institutional review boards (IRBs)
- Ensured compliance with local regulations regarding informed consent process; reviewed informed consent forms for clarity and completeness
- Coordinated resolution of queries raised during data cleaning/validation process between sites/study team/central laboratory/vendors as needed
- Supported project management activities such as tracking timelines/milestones/deliverables
Clinical Research Associate at Fortrea (formerly Covance & LabCorp) (2021-06 – 2023-07)
- On-site monitoring of Phase I-IV trials for Sponsors including AstraZeneca, Travere, and Orphan Technologies
- Management of site issues
- Ensure site staff training for ICH/GCP, IATA, EDC, and protocol-specific training with documentation
- Use of EMR Systems, EDC data entry and query resolution, Trial Master File, and CTMS
- Site Selection, Site Initiation Visits, Interim Routine Monitoring Visits, Close-Out Visit conduct
- Site communication, Visit (Trip) Reporting, and Follow-Up Letters
- Managed investigational product accountability at the site level, including storage, dispensing, reconciliation, and return/disposal processes
- Provided training on protocol requirements, study procedures, and data collection tools to site staff members
- Monitored adverse events reported by study participants or identified during site visits; promptly communicated findings to the sponsor
- Maintained comprehensive documentation of all monitoring activities in accordance with company SOPs and regulatory guidelines
- Assisted in the preparation of regulatory submissions for ethics committees/institutional review boards (IRBs)
- Ensured compliance with local regulations regarding informed consent process; reviewed informed consent forms for clarity and completeness
- Coordinated resolution of queries raised during data cleaning/validation process between sites/study team/central laboratory/vendors as needed
- Supported project management activities such as tracking timelines/milestones/deliverables
Clinical Research Associate II at IQVIA/Aerotek (2020-10 – 2021-05)
- Initiated and completed Eli Lilly Phase III clinical trial for COVID-19 antibody infusions in Skilled Nursing Facilities throughout Illinois and Colorado
- Implemented training for research nurses and study coordinators
- SDV/SDR for Data entry per Case Report Forms (CRFs) and Electronic Data Capture (EDC) Remote monitoring of CRFs/eCRFs ensuring GCP and FDA-compliance in data collection, site inventory, patient medical charts and test results
- Maintain communication between study team, Principal Investigator, sites, and Sponsor
- Developed and maintained strong relationships with investigators, site staff, and study participants
- Performed source data verification to ensure accuracy and completeness of clinical trial data
- Collaborated with cross-functional teams including medical affairs, biostatistics, data management, and pharmacovigilance departments
- Assisted in the review and analysis of clinical trial data, identifying trends or potential issues that required further investigation
- Supported the coordination of safety reporting activities, including adverse event reporting and serious adverse event reconciliation
- Maintained accurate and up-to-date tracking systems for essential documents such as investigator CVs, training records, and regulatory approvals
- Ensure site staff training for ICH/GCP, IATA, EDC, and protocol-specific training with documentation
- Use of EMR Systems, EDC data entry and query resolution, Trial Master File, and CTMS
- Site Selection, Site Initiation Visits, Interim Routine Monitoring Visits, Close-Out Visit conduct
- Site communication, Visit (Trip) Reporting, and Follow-Up Letters
- Managed investigational product accountability at the site level, including storage, dispensing, reconciliation, and return/disposal processes
- Provided training on protocol requirements, study procedures, and data collection tools to site staff members
- Monitored adverse events reported by study participants or identified during site visits; promptly communicated findings to the sponsor
- Maintained comprehensive documentation of all monitoring activities in accordance with company SOPs and regulatory guidelines
- Assisted in the preparation of regulatory submissions for ethics committees/institutional review boards (IRBs)
- Ensured compliance with local regulations regarding informed consent process; reviewed informed consent forms for clarity and completeness
- Coordinated resolution of queries raised during data cleaning/validation process between sites/study team/central laboratory/vendors as needed
- Supported project management activities such as tracking timelines/milestones/deliverables
Clinical Research Coordinator at Optimal Research, LLC (2020-06 – 2020-09)
- Executed high-volume healthy subject vaccine clinical trials for Respiratory Syncytial Virus, Influenza, and Coronavirus
- Data entry via Case Report Forms (CRFs) and Electronic Data Capture (EDC)
- CRA collaboration in ensuring GCP and FDA-compliance in data collection
- Manage regulatory documents, study material inventory, patient medical charts and test results
- Managed investigational product accountability including receipt, storage, dispensing, reconciliation, and return/destruction processes
- Conducted monitoring visits to participating sites to verify adherence to protocols and regulatory requirements
Clinical Research Coordinator II at Accelerated Enrollment Solutions (formerly Synexus Clinical Research US) (2017-12 – 2020-06)
- Launched 13 clinical trials, facilitated staff training, and recruited qualifying patients
- Performed Data entry via Case Report Forms (CRFs) and Electronic Data Capture (EDC)
- Communication with Sponsor to exhibit GCP and FDA-compliance in data collection
- Managed patient visits, investigational product, regulatory documents, device inventory, and patient medical charts with test results
- Recruited and screened eligible participants for clinical trials, maintaining accurate records of enrollment and eligibility criteria
- Managed investigational product accountability including receipt, storage, dispensing, reconciliation, and return/destruction processes
- Contributed to the development of standard operating procedures (SOPs) for various aspects of clinical trial operations
- Led regular meetings with cross-functional teams including investigators, sponsors/vendors, laboratory personnel etc. ensuring effective communication throughout the duration of each trial
- Tracked project milestones using project management tools/software ensuring timely completion of deliverables
