Vanessa Ruiz
Hockley,TX
Summary
Results-driven Clinical Research Professional with over 10 years of experience in overseeing and managing clinical trials across various therapeutic areas. Proven track record in developing and implementing robust study protocols, ensuring compliance with regulatory standards, and enhancing participant recruitment and retention strategies. Adept at leading cross-functional teams, fostering collaboration among clinical staff, sponsors, and stakeholders to drive project success. Committed to advancing initiatives that prioritize patient safety and improve healthcare outcomes.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Program Supervisor
DM Clinical Research
01.2024 - 10.2024
- As a Program Supervisor, I tracked multiple projects and reviewed all ongoing studies progress with internal and external stakeholders, including CROs, industry partners, and consultants.
- Oversaw clinical staff training and development programs, ensuring employees were equipped with the skills needed to excel in their roles.
- Facilitated regular team meetings, keeping staff informed about updates, changes, or upcoming events related to the program they supervised.
- Demonstrated strong leadership skills under challenging circumstances, effectively managing team dynamics during periods of transition or high-stress environments.
- Evaluated clinical program performance regularly, using data-driven insights to inform future decision-making processes at local and nationwide site locations.
- Implemented quality assurance initiatives to enhance patient care, satisfaction and safety protocols.
Patient Enrollment Supervisor
DM Clinical Research
10.2021 - 01.2024
- As a Patient Enrollment Therapeutic Supervisor, I managed a team of 20+ patient enrollment specialists on meeting clinical trial enrollment goals for all current enrolling programs and projections for upcoming programs in the pipeline.
- Provided guidance, training, and oversight for multiple clinical research studies ensuring compliance with the informed consent process, protocols, study documentation, and Standard Operating Procedures (SOPs) Communications.
- Collaborated daily with Clinical Research Coordinators, Study Managers, and Licensed Physicians to develop and implement strategies for subject recruitment to achieve randomization goals.
- Traveled to and from all clinical sites, physician offices, and met regularly with pharmaceutical representatives and sponsors such as Pfizer and Moderna on nationwide enrollment timelines and milestones.
- Conducted performance evaluations for staff members, identifying areas of improvement and guiding professional development plans.
- As a supervisor, I led a team of patient enrollment specialists that contributed to exceeding randomization goals by 50% for Moderna's Respiratory Syncytial Virus (RSV) Preventative Vaccine which has now been granted FDA Authorization and Approval.
Patient Enrollment Specialist
DM Clinical Research
07.2017 - 10.2021
- As a Patient Enrollment Specialist I answered inbound calls from potential clinical trial participants and provide detailed information about study protocols, eligibility criteria, and enrollment processes.
- Made over 80 outbound calls daily to follow up with interested participants, schedule appointments, and conduct preliminary screenings.
- Worked closely with clinical research coordinators and investigators to ensure seamless communication regarding participant referrals and appointments.
- Screened potential participants at the clinical trial sites for eligibility and obtain informed consent.
- Monitored compliance with Good Clinical Practice (GCP), Institutional Review Board (IRB) requirements, and regulatory standards.
- Conducted daily patient reports and reviews for Clinical Investigators in multiple EHR systems such as Cerner, MEDITECH, eClinicalworks, Epic, and Athena.
Recruiter
Novum Pharmaceutical Research Services
05.2012 - 06.2017
- As a Patient Recruiter I was responsible for providing comprehensive support to ensure the efficient operation of the clinical research clinic. and enrollment by maintaining proper patient flow, coordinating communications, and supporting clinical staff in their daily activities.
- Conducted outreach through various channels, including community events, social media, and healthcare providers, to raise awareness about clinical trials.
- Built relationships with healthcare professionals in the Houston Metropolitan area to facilitate referrals of eligible patients.
- Assisted in the informed consent process, ensuring that participants understand their rights and responsibilities.
- Utilized databases and tracking systems to monitor recruitment progress and report findings to management.
- Maintained accurate records of clinical trial activities, participant interactions, and regulatory documents.
Skills
- Analytical and Problem-Solving Skills
- Staff Training and Development
- Regulatory Compliance Research
- Operational Leadership
- Program Optimization
- Clinical Documentation
- Electronic Data Capture
- Clinical Trial Management
- HIPAA Compliance
- Patient Care
Certification
- Human Subject Protection
- Association of Clinical Research Professionals Good Clinical Practice
- NIDA Clinical Trial Networks- OSHA Blood-borne Pathogens
- CITI Program, Shipping and Transport of Regulated Biological Materials
- CITI Program, GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
- CITI Program, For the Shipping of Infectious Substance Affecting Humans and Biological Substances
Timeline
Program Supervisor
DM Clinical Research
01.2024 - 10.2024
Patient Enrollment Supervisor
DM Clinical Research
10.2021 - 01.2024
Patient Enrollment Specialist
DM Clinical Research
07.2017 - 10.2021
Recruiter
Novum Pharmaceutical Research Services
05.2012 - 06.2017
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