Clinical Research Associate II

• Jul 2023 - Present

Clinical Research Consultant

• May 2023 - May 2023

• Assisted in transferring PDF documentation into EMR system • Collaborated with Clinical, Quality, & R&D teams • Performed clinical data and query review • Reading SOP & Physician notes • Performed and supported validation of data management system. • Assisted with the creation and maintenance of documentation for following CRF guidelines and other guidelines. • Tracking and updating subjects data using excel spreadsheets. • Assisted in transferring PDF documentation into EMR system • Collaborated with Clinical, Quality, & R&D teams • Performed clinical data and query review • Reading SOP & Physician notes • Performed and supported validation of data management system. • Assisted with the creation and maintenance of documentation for following CRF guidelines and other guidelines. • Tracking and updating subjects data using excel spreadsheets.

Clinical Research Associate

• Jul 2021 - Aug 2022

• Ensured clinical studies are carried out in compliance with Sight Sciences corporate policies and procedures, and applicable regulatory guidelines, standards, laws and regulations. • Under the supervision of a Study Manager or designated study lead, contributed to study design, development, conduct and closure. • Assisted in the creation, review and/or revision of key study documents, including but not limited to protocol, investigator brochures, informed consent document templates, monitoring plans, monitoring visit report templates, and other trial tools. • Responsible for study Start-up activities including managing essential trial documents and Trial Master File (TMF) • Monitoring recruitment remotely through EDC systems and/or communication with sites • Preparing and reviewing various study-related tracking systems to determine and report status of clinical trial documents (i.e. distribution, status, retrieval of such documents as protocol, IB, etc.) • Participated in coordinating and securing IRB approval for Sponsor • Managed multiple clinical study sites across multiple studies to facilitate trial deliverables and assured timelines are met. This includes accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials • Served as primary contact for assigned investigative sites • Under the supervision of a study manager of designated team lead, coordinated all activities for setting up and monitoring a study, completing accurate study visit reports and maintaining study documentation. Show less

Clinical Research Associate

• Sep 2020 - Jun 2021

• Monitors clinical studies of investigational and approved products remotely and through on-site visits • Conducts qualification, initiation, interim monitoring, and close out site visits • Acts as primary liaison between the study site staff and Concept • Monitors studies by reviewing and reporting on the following: site recruitment efforts, enrollment and subject status, findings at monitoring visits, protocol deviations/exceptions, serious adverse events and laboratory abnormalities • Reviews source data and case report forms for accuracy, completeness, and integrity of the data, and identifies and resolves ongoing data issues• Meets with the Principal Investigator at the end of the visit to provide any updates and discuss findings and concerns • Processes or oversees transmission of study data according to protocol-specified timelines • Reviews data queries and listings and working with the study site staff to resolve data discrepancies • Oversees the study site staff to assess protocol compliance and appropriate data collection including proper handling, storage and shipment of biological samples or imaging scans Show less

Patient Care Coordinator

• Apr 2019 - Nov 2020

• Assisted trial Investigator in screening and review of potential study participant’s eligibility. • Maintained case reports forms, charts and documentation. • Ensured that all clinical activities were carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. • Lead in the recruitment of study subjects. • Collected and entered data as necessary. • Performed miscellaneous job-related duties as assigned. • Aided in assessing eligibility of patients for participation in protocols. • Participated in the administration of informed consent process. • Responsible for the collection, entering, maintenance of data. • Reviewed data and progress notes with CRCs and principal investigator. • Prepared study files for data. • Prepared lab kits for upcoming research visits. • Processed blood and urine samples for shipping. • Performed back-up care coordination if needed by trial schedule. Show less

Intern Clinical Research Associate

• Jun 2020 - Aug 2020

• Shadowed a senior CRA to perform all types of visit types SQV, SIV, IMV, COV. • Trained on ICH-GCP • Perform Protocol and Study related training. • Attends Investigator Meetings and study-specific training for assigned trials. • Draft monitoring plan • Develops and maintains collaborative working relationships with clinical investigative sites. • Co-monitored with senior CRA to conduct meetings with the Investigator and Study Coordinator at each site visit and with other key staff, as needed. • Communicate with the investigator and site staff as necessary to address questions, issues, or provide information. • Complete IP accountability reviews and ensure that IP is stored and dispensed properly. • Perform Source Data Verification per Clinical Monitoring Plan. • Understands assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites. • Assist the Clinical Trial Managers with development of study plans, informed consent documents, case report forms (CRFs), site source documentation, etc. • Perform co-monitoring visits with senior CRAs to ensure quality of monitoring; provide training and guidance as needed. • Compiles and submits data on appropriate forms according to protocol requirements. • Establishes and maintains interpersonal relationships with patients, visitors and other hospital personnel, while assuring confidentiality of patient information • Works on special data management projects as assigned. • Plays active role in recruitment of patients to study. • Performs protocol specific duties as required per the research study. • Attends and participates in meetings as required. Show less

Program Coordinator

• Oct 2018 - Jun 2019

• Supervised staff as specified in each client’s individual support plan to strongly execute training programs • Offered resourceful problem solving, both internally and externally, while developing and maintaining strong • client relationships • Handled follow-up telephone calls, clerical support, data entry and maintained client database • Scheduled appointments/meetings and made necessary arrangements for meetings as required • Performed research for special planning. • Monitor and schedule house and vehicle projects as assigned and prepared presentation material • Complete staff evaluations. • Monitor and maintain residential budget and overtime. • Monitored and scheduled required staff training's, seminars, and conferences. • Monitor fiscal, medical, personal and ISP documentation to ensure accuracy. • Participate in Circle(s) of Support for personal future maintenance. • Oversee the maintaining and monitoring of individuals' finances. • Build a support network between the individuals and community members. • Prepared progress reports for consumer's immediate support group. • Ensured consistent service delivery that connects work, home, and recreational needs. • Submitted monthly written reports to the appropriate individuals outlining operational status, progress, and concerns. • May perform the duties of Direct Support Professional as necessary, in accordance with current staffing needs. Show less