JADE VILLANUEVA
Houston,TX
Summary
Organized and decisive Clinical Research Coordinator well-versed in trial procedures, regulatory requirements and limitations. Maintains compliance with standards and protects patients through proper processes. Brings impeccable reputation for running quality Clinical trials. Reliable candidate ready to take on challenges using problem-solving and task prioritization skills to help team succeed. Dedicated professional with demonstrated strengths in customer service, time management and trend tracking. Good at troubleshooting problems and building successful solutions. Excellent verbal and written communicator with strong background cultivating positive relationships and exceeding goals.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Proalto Clinical Research Center
08.2024 - Current
- Coordinated and managed clinical research studies, ensuring adherence to protocols, regulatory requirements, and timelines
- Recruited and screened eligible participants for clinical trials, maintaining accurate records of enrollment and eligibility criteria
- Scheduled study visits, procedures, and follow-up appointments with participants in accordance with study protocols
- Collected and recorded data accurately and promptly using electronic data capture systems or case report forms (CRFs)
- Maintained comprehensive study documentation including informed consent forms, source documents, and regulatory binders
- Ensured compliance with Good Clinical Practice (GCP) guidelines throughout the conduct of clinical trials
- Managed investigational product accountability including receipt, storage, dispensing, reconciliation, and return/destruction processes
- Performed quality control checks on collected data to ensure accuracy and completeness
- Conducted monitoring visits to participating sites to verify adherence to protocols and regulatory requirements
- Coordinated site initiation activities including training sessions for site staff on study procedures and protocol requirements
- Provided ongoing support to investigators by addressing queries related to study procedures or participant management issues
- Coordinated with clinical research associates (CRAs) to ensure timely resolution of data queries and discrepancies
- Maintained up-to-date knowledge of relevant regulations, guidelines, and industry best practices related to clinical research coordination
- Willing to relocate: Anywhere
- Authorized to work in the US for any employer
Lead Clinical Research Coordinator
Mercury Clinical Research
12.2023 - Current
- Documented laboratory data and adverse reactions with immediate notifications about serious adverse events
- Handled start-up work, including business recruitment tools, tracking progress and screening participants
- Managed technical requirements of study protocol, including lab work, monitoring and screenings
- Built successful relationships with investigators and communicated openly about trial status
- Scheduled patient care appointments, procedures and diagnostic testing for over [Number] participants
- Onboarded new participants, including presenting trial concepts and details, managing informed consent and enrolling individuals in clinical protocols
- Prepared protocol worksheets, procedural manuals and other study-related documentation
- Monitored active studies to verify compliance with facility's protocols and regulatory standards, helping to protect personnel from legal issues
- Protected study results by carefully obtaining and documenting subjects' informed consent
- Kept meticulous records for internal and regulatory needs, including drug dispensation and case report forms
- Documented adverse events and data covering side effects, conferring with investigators about reports and working with oversight agencies on management of incidents
- Screened potential subjects, reviewed medical records and discussed histories with physicians or nurses to determine which individuals should be admitted to each study
- Demonstrated strong attention to detail in reviewing source documents for accuracy and completeness during monitoring visits
Clinical Research Coordinator
Research Physicians Network, LLC
10.2023 - Current
- Maintain awareness of status of all active studies
- Arrange for facilities and supplies
- Ensure participant and study compliance, i.e
- Collection of study specimens, and study visits
- Work with study team as needed to define specimen collection, processing and storage procedures
- Train others as needed to collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedures (SOP) or other work instruction set
- Ensure specimens are properly logged, handled and stored
- Maintain all records and files required by regulatory agencies and sponsors
- Serve as a resource for other clinical research professionals in all aspects of conducting a clinical trial
- Collaborate with investigator(s) and coworkers to ensure proper progress and completion of clinical studies
- Train new staff in preparation and conduct of clinical trials
Clinical Research Coordinator
Synergy Group LLC
09.2021 - 05.2022
- Documented laboratory data and adverse reactions with immediate notifications about serious adverse events
- Handled start-up work, including business recruitment tools, tracking progress and screening participants
- Managed technical requirements of study protocol, including lab work, monitoring and screenings
- Built successful relationships with investigators and communicated openly about trial status
- Scheduled patient care appointments, procedures and diagnostic testing for over [Number] participants
- Onboarded new participants, including presenting trial concepts and details, managing informed consent and enrolling individuals in clinical protocols
- Prepared protocol worksheets, procedural manuals and other study-related documentation
- Monitored active studies to verify compliance with facility's protocols and regulatory standards, helping to protect personnel from legal issues
- Protected study results by carefully obtaining and documenting subjects' informed consent
- Kept meticulous records for internal and regulatory needs, including drug dispensation and case report forms
- Documented adverse events and data covering side effects, conferring with investigators about reports and working with oversight agencies on management of incidents
- Screened potential subjects, reviewed medical records and discussed histories with physicians or nurses to determine which individuals should be admitted to each study
Caregiving Manager
Reach Healthcare Services
07.2017 - 11.2020
- Fostered compassionate care delivery, leveraging experience with case management, discharge planning and patient education
- Verified patient progress towards desired outcomes by continuously monitoring patient care
- Encouraged patients to take active role in decision-making regarding long-term care plans
- Analyzed and resolved barriers impeding effective care
- Worked in conjunction with care team and PCP as care team leader
- Met coverage demands by establishing work schedules and assigning specific jobs
- Improved care delivery by monitoring performance and optimizing strategies
Certified Nurse Aide
Gardens of Bellaire
12.2010 - 11.2012
- Handled non-medical patient care activities and provided laundry and meal assistance
- Documented care actions, vitals and orders in company software
- Supported clients to take prescribed medication at correct times and dosage
- Worked alongside registered nursing staff and followed care plans
- Promoted independence while assisting with personal hygiene needs
- Changed bed linen regularly to help prevent skin irritation
- Collaborated with physicians and registered nurses to perform procedures
- Specialized in delivering high quality care to [Type] patients
- Used initiative to respond quickly in emergency situations
- Offers support, companionship and stimulation with conversation and recreation
- Assisted with activities of daily living to improve patient quality of life
- Built friendly rapport with patients and delivered personalized care
- Performed light housekeeping tasks and ran errands
- Prepared patients for treatments, visits and social activities
- Helped patients to complete routine exercises to build mobility
- Kept rooms clean and ready to meet individual needs
Education
High School Diploma - undefined
South Houston High School
South Houston, TX01.2007
Skills
- Documentation review
- Epic
- Records management
- Enrollment oversight
- Microsoft Office
- Adverse event tracking
- Analytical thinking
- Good driving record
- HIPAA
- Ability to multitask
- Customer service
- Data collection
- [Type] Software
- Time management
- Protocol development
- Participant screening
- Communication skills
- EMR systems
- Organizational skills
- Social perceptiveness
- Enrollment coordination
- Study monitoring
- Written communication
Certification
CPR Certification
Languages
Spanish
Native or Bilingual
Timeline
Clinical Research Coordinator
Proalto Clinical Research Center
08.2024 - Current
Lead Clinical Research Coordinator
Mercury Clinical Research
12.2023 - Current
Clinical Research Coordinator
Research Physicians Network, LLC
10.2023 - Current
Clinical Research Coordinator
Synergy Group LLC
09.2021 - 05.2022
Caregiving Manager
Reach Healthcare Services
07.2017 - 11.2020
Certified Nurse Aide
Gardens of Bellaire
12.2010 - 11.2012
High School Diploma - undefined
South Houston High School