- Houston, TEXAS
- November 15, 2023
Highly motivated Clinical Research Associate well-versed in standard operating procedures and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring 7+ years of related experience to a challenging new role. Versed in confirming subject safety and data integrity. Successful at reviewing regulatory documentation for accuracy and completeness and supporting study centers with issues. Serves as point-of-contact for clinical research professionals and coordinates lab samples to compile detailed data.
Education
Bachelors degree
Experience
● Provides support to the Project Team and Clinical Operations Team.
● Maintains strong working knowledge of Influenza, and Covid-19 protocols and Monitoring Plans for
assigned projects.
● Demonstrates strong written and verbal communication skills.
● Serves as primary contact for assigned Covid-19, and Influenza research sites.
08/01/2023 to Present
● Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.
● Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits
and close-out visits according to the Monitoring Plan.
● Ensures research sites conduct studies for according to Influenza, and Covid-19 protocol or
investigational plan and applicable regulations and guidelines.
● Verifies the rights and well-being of trial subjects are protected.
● Reconciles site regulatory binder assuring collection and completeness of regulatory documents.
● Collects and ensures completeness of all essential regulatory documentation from study startup through
close-out.
● Verifies that written informed consent was obtained before each subject's participation in the trial.
● Verifies that the investigator is enrolling only eligible subjects.
● Performs source data verification against Case Report Form/Electronic Data Capture entries in
compliance with the Monitoring Plan.
● Ensures accurate and complete data and that corrections are appropriately documented by authorized site
staff.
● Served as an ambassador for research studies so that subjects find our enrollment and informed consent process welcoming, manageable, and accessible.
● Conducted site initiation visits.
● Communicated with investigators and their staff.
● Ensured compliance with terms and conditions.
● Trained site personnel according to Good Clinical Practices and the Code of Federal Regulations.
● Wrote site initiation visit reports.
● Supervised the conduct of clinical studies in the field.
● Acted as a liaison between site personnel and the sponsor.
● Performed monitoring visits.
● Ensured compliance with protocols, regulatory requirements, and good clinical practices.
Protected study results by carefully obtaining and documenting subjects' informed consent.
● Conducted in-house Covid-19 vaccine- related studies, and independently performed on-site monitoring
in accordance with Standard Operating Procedures, ICH GCP guidelines and Regulations.
● Participated in assessing study risks.
● Communicated on behalf of the study manager with investigators and site staff.
● Prepared study performance reports and provided input into study budgets.
● Managed study supply inventory (Covid-19 Vaccine, study pamphlet, and lab supplies) and shipping.
● Conducted and assessed site readiness and assisted in creating site monitoring plans for Covid-19
Vaccine study.
● Worked across multiple project teams, indications, and different study designs.
● Assisted in the creation of study materials (CRFS, operation manuals, protocols, etc.).
● Assisted in the creation of departmental operating procedures and tracking systems.
● Facilitated data collection and study execution in collaboration with other research staff.
Assisted trial Investigator in screening and review of potential study participants eligibility.
● Maintained case report forms, charts, and documentation.
● Performed miscellaneous job-related duties as assigned.
● Managed studies with the sponsor, Site Director, and Principal Investigator to ensure compliance with
protocol requirements.
● Managed studies with Principal Investigator, Site Director, and Recruitment Manager to develop
effective programs for study enrollment.
● Served as a mentor and trainer for support staff and new employees.
● Collaborated with primary investigator, sponsor, and research staff to plan, conduct, and evaluate project
protocols.
● Monitored and reported on progress of projects.
● Assisted with the recruitment, selection, scheduling, and monitoring of research project participants.
● Managed the handling of adverse events, compliance, and other participant-related issues.
● Coordinated the preparation and delivery of departmental communications, presentations, and
marketing/educational materials.
