Helimenes De Jesus Molero Romero
Miramar
Summary
Results-driven clinical research professional with a strong track record in managing complex studies and ensuring strict compliance with protocols and regulations. Skilled in leading cross-functional teams, optimizing project workflows, and maintaining high-quality data integrity. Adept at adapting to evolving project needs while delivering results on time and within scope. Diligent Clinical Research Coordinator with comprehensive background in coordinating clinical research studies. Successfully managed multiple clinical trials from initiation to closeout, ensuring adherence to regulatory guidelines. Demonstrated ability to effectively communicate with cross-functional teams and maintain meticulous documentation.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator II
CenExel Clinical Research
Hollywood, FL
11.2025 - Current
- Coordinated clinical trial activities to ensure adherence to protocols and regulatory requirements.
- Managed patient recruitment efforts, enhancing participant enrollment through targeted outreach strategies.
- Oversaw data collection processes, ensuring accuracy and compliance with study protocols and timelines.
- Developed and maintained study documentation, including informed consent forms and regulatory submissions.
- Collaborated with cross-functional teams to streamline communication and project workflows for clinical studies.
- Trained and mentored junior staff on best practices in clinical research methodologies and compliance standards.
- Implemented process improvements that increased efficiency in trial operations and reduced turnaround times.
- Led site visits and monitoring activities, evaluating performance metrics against study objectives for continuous improvement.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Followed informed consent processes and maintained records.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
Clinical Research Coordinator I
Cenexel Hollywood FL
Hollywood
01.2025 - 11.2025
- Directed daily clinical trial operations for 10+ studies, including participant recruitment, scheduling, and protocol implementation, ensuring strict adherence to study protocols, timelines, and regulatory guidelines.
- Prepared, and maintained regulatory documentation, including IRB submissions, informed consent forms, and safety reports, achieving full compliance with Good Clinical Practice (GCP), FDA, and international regulatory standards.
- Created and maintained clinical trial source documents, ensuring accurate, complete, and verifiable data for audits, monitoring visits, and regulatory submissions.
- Oversaw data management, supervising collection, entry, and validation to ensure accuracy, completeness, and consistency; generated detailed reports for sponsors and regulatory authorities.
- Obtained and documented informed consent, ensuring participants fully understood study procedures, risks, and benefits; maintained engagement and improved participant retention.
- Trained and mentored research staff, enhancing workflow efficiency, compliance, and overall team performance.
- Conducted audits and monitoring visits to ensure protocol adherence, identify operational gaps, and implement process improvements to elevate study quality and efficiency.
- Collaborated with Principal Investigators, sponsors, CROs, and internal stakeholders, facilitating effective communication, resolving issues, and supporting smooth study progression.
- Assisted in study planning, optimizing operational efficiency while maintaining compliance and quality standards.
- Supported risk management initiatives, including adverse event reporting, protocol deviations, and corrective action implementation.
- Performed clinical visits, including but not limited to ECGs, obtaining vital signs, blood sample collection, processing, and shipment, ensuring accurate and timely data capture.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Provided interim unit supervision for 25+ patients, supporting daily operations, patient safety, and continuity of care in coordination with clinical staff.
- Performed patient de-escalation and crisis support, utilizing therapeutic communication techniques to maintain a safe, respectful, and supportive clinical environment.
- Collaborated closely with dietitians and multidisciplinary care teams to support individualized patient care plans, dietary compliance, and overall treatment outcomes.
- Performed inpatient admission checks for 25+ patients, verifying documentation, medical history, and consent to ensure accurate, compliant, and timely patient onboarding.
Senior Research Assistant
CenExel Clinical Research
Hollywood, FL
05.2024 - 01.2025
- Led research projects to develop innovative methodologies enhancing data collection and analysis.
- Mentored junior researchers, fostering skill development and knowledge sharing within the team.
- Collaborated with cross-functional teams to design experiments, improving project outcomes and timelines.
- Analyzed complex datasets using statistical software, ensuring accuracy and reliability of findings.
- Developed comprehensive reports summarizing research results for internal and external stakeholders.
- Streamlined research protocols, increasing efficiency in data processing and documentation workflows.
- Managed lab resources effectively, maintaining adequate inventory levels and equipment maintenance schedules.
- Presented research findings at conferences and workshops, promoting the organization''s expertise in the field.
- Collaborated with multidisciplinary teams to achieve project milestones and deliverables.
- Optimized research protocols, leading to increased accuracy and reliability of results.
- Assisted in production of research reports and articles for peer-reviewed journals.
Clinical Research Assistant I
CenExel Clinical Research
Hollywood, FL
03.2023 - 05.2024
- Coordinated participant recruitment and retention strategies to ensure study enrollment targets were met.
- Conducted thorough data collection and management, ensuring compliance with regulatory standards.
- Assisted in the development of study protocols and informed consent documents for clinical trials.
- Collaborated with cross-functional teams to streamline project workflows and improve operational efficiency.
- Analyzed data trends to identify potential issues, improving overall study performance metrics.
- Developed comprehensive reports summarizing findings for stakeholders, enhancing decision-making processes.
- Participated in site monitoring visits, addressing any concerns or discrepancies related to patient enrollment or data collection procedures.
- Maintained up-to-date knowledge of industry regulations by attending professional development seminars and reviewing relevant publications regularly.
- Educated patients regarding all facets of clinical study participation.
Medical Scheduler Coordinator/Medical Assistant
The Hand and Upper Extremity Center of Georgia
Atlanta
01.2021 - 03.2023
- Coordinated and scheduled 30+ patient appointments daily with physicians, specialists, and for procedures, ensuring timely, accurate, and efficient scheduling while optimizing provider availability and patient flow.”
- Serve as the primary point of contact for patients, providing clear instructions regarding appointment details, required preparations, and necessary documentation.
- Maintain and manage providers’ calendars, preventing conflicts or overlaps and optimizing daily workflow for physicians and staff.
- Verify patient information and insurance coverage, ensuring appointments and procedures are properly prepared and authorized.
- Facilitate communication between patients and healthcare providers, addressing inquiries, resolving scheduling issues, and enhancing patient satisfaction.
- Track and manage follow-up appointments and referrals, supporting continuity of care and timely access to specialty services.
- Collaborate with clinical and administrative staff, ensuring smooth coordination of patient flow, resources, and clinic operations.
- Identify workflow inefficiencies and recommend process improvements to enhance scheduling accuracy and clinic productivity.
Medical Assistant
Clinica Sucre
Maracaibo, Venezuela
04.2020 - 10.2020
- Monitored and recorded average of 30 patients per day. Directed patients to exam rooms, fielded questions and prepared for physician examinations.
- Promoted office efficiency, coordinating charts, completing insurance forms, and helping patients with diverse needs. Documented vital signs and health history for patients in clinic and hospital environments.
- Prepared patients for X-rays, electrocardiograms, suture removal and dressing changes. Assisted with routine checks and diagnostic testing by collecting and processing specimens. Scheduled appointments, registered patients, and distributed sample pharmaceuticals as prescribed. Called and faxed pharmacies to submit prescriptions and refills.
- Kept medical supplies in sufficient stock by monitoring levels and submitting replenishment orders before depleted. Sanitized, restocked, and organized exam rooms and medical equipment.
Medical Assistant
Cardimed
Maracaibo, Venezuela
12.2019 - 04.2020
- Assisted with routine checks and diagnostic testing by collecting and processing specimens +15.
- Directed patients to exam rooms, fielded questions and prepared for physician examinations.
- Promoted office efficiency, coordinating charts, completing insurance forms, and helping patients with diverse needs.
- Documented vital signs and health history for patients in clinic and hospital environments.
Education
Health Science BS -
Miami Dade College
Dade City, FL2 2026
Medicine -
Buenos Aires University
Buenos Aires11 2019
Skills
- Good clinical practices
- Electronic data capture
- Documentation management
- Informed consent process
- Multitasking Abilities
- Problem-solving abilities
- Adverse event reporting
- Data analysis
- Patient recruitment
- Trial management
- Data collection techniques
- Schedule coordination
- Trial oversight
Certification
- BLS Certification | May 2024
- CITI Certification | March 2023-Present
- GCP Certification | March 2023-Present
Languages
English and Spanish Fluency
Timeline
Clinical Research Coordinator II
CenExel Clinical Research
11.2025 - Current
Clinical Research Coordinator I
Cenexel Hollywood FL
01.2025 - 11.2025
Senior Research Assistant
CenExel Clinical Research
05.2024 - 01.2025
Clinical Research Assistant I
CenExel Clinical Research
03.2023 - 05.2024
Medical Scheduler Coordinator/Medical Assistant
The Hand and Upper Extremity Center of Georgia
01.2021 - 03.2023
Medical Assistant
Clinica Sucre
04.2020 - 10.2020
Medical Assistant
Cardimed
12.2019 - 04.2020
Medicine -
Buenos Aires University
Health Science BS -
Miami Dade College