Tahimi de la campa
Miami,FL
Overview
14
14
years of professional experience
Work History
Lead Research Coordinator/Regulatory
Bio Research Partner
10.2024 - Current
- Manage day-to-day operations of clinical trials, ensuring adherence to study protocols and timelines.
- Coordinate patient recruitment, screening, consent, and enrollment to achieve study enrollment targets.
- Prepare and submit regulatory documents, including IRB submissions, safety reports, and protocol amendments.
- Ensure compliance with ICH-GCP, FDA, and other applicable regulatory guidelines.
- Maintain accurate and complete study documentation, including source documents and regulatory binders.
- Monitor and report adverse events, protocol deviations, and compliance issues to appropriate authorities.
- Serve as the primary point of contact during audits and inspections, ensuring proper resolution of findings.
- Collaborate with investigators, sponsors, and clinical research associates to facilitate data monitoring and database clean-up processes.
- Lead and mentor a team of research coordinators to ensure successful execution of clinical trials.
Lead Research Coordinator/Regulatory
PharmaDev Research
01.2024 - 10.2024
- Manage day-to-day operations of clinical trials, ensuring adherence to study protocols and timelines.
- Coordinate patient recruitment, screening, consent, and enrollment to achieve study enrollment targets.
- Prepare and submit regulatory documents, including IRB submissions, safety reports, and protocol amendments.
- Ensure compliance with ICH-GCP, FDA, and other applicable regulatory guidelines.
- Maintain accurate and complete study documentation, including source documents and regulatory binders.
- Monitor and report adverse events, protocol deviations, and compliance issues to appropriate authorities.
- Serve as the primary point of contact during audits and inspections, ensuring proper resolution of findings.
- Collaborate with investigators, sponsors, and clinical research associates to facilitate data monitoring and database clean-up processes.
- Lead and mentor a team of research coordinators to ensure successful execution of clinical trials.
Clinical Research Coordinator
Miami Clinical Research
11.2019 - 10.2023
- Conducted patient care visits, ensuring compliance with study protocols and procedures.
- Managed patient recruitment, screening, and enrollment for clinical trials, meeting enrollment goals.
- Maintained accurate and up-to-date study documentation, including case report forms and source documents.
- Coordinated and scheduled study-related activities such as laboratory tests, drug accountability, and follow-up visits.
- Monitored and reported adverse events, ensuring patient safety and adherence to study requirements.
- Collaborated with investigators, sponsors, and clinical research associates to ensure protocol adherence and data quality.
- Assisted with regulatory submissions, including IRB submissions, amendments, and safety reports.
- Entered and managed data in electronic data capture (EDC) systems, ensuring accuracy and completeness.
- Provided ongoing support to patients, ensuring clear communication and understanding of study procedures.
Clinical Research Coordinator/Regulatory
Lcc Medical Research
01.2015 - 11.2019
- Oversaw clinical research study activities, including patient recruitment, screening, enrollment, and follow-ups, achieving and exceeding enrollment targets.
- Conducted phone screenings with potential participants to determine eligibility and scheduled screening visits for ongoing and upcoming studies.
- Prepared and maintained regulatory documentation, including IRB submissions, amendments, safety reports, and study binders, ensuring compliance with FDA, ICH-GCP, and other regulatory guidelines.
- Managed study protocols, including tracking patient visits, coordinating lab tests, and ensuring proper drug accountability.
- Monitored and documented adverse events, protocol deviations, and compliance-related issues while ensuring accurate reporting to regulatory authorities.
- Worked closely with investigators and sponsors to ensure protocol adherence and smooth study execution.
- Entered and verified data in electronic data capture (EDC) systems, ensuring accuracy and completeness of study records.
- Collaborated with clinical research associates (CRAs) during monitoring visits and audits, addressing queries and resolving data discrepancies.
- Provided exceptional patient care by explaining study procedures, obtaining informed consent, and addressing participant concerns.
Relief Manager
Public Storage
01.2014 - 01.2015
- Managed daily operations of the storage facility, including customer service, sales, and property maintenance.
- Provided exceptional service to customers by assisting with rental agreements, account management, and payment processing.
- Conducted regular inspections of the property to ensure cleanliness, security, and compliance with company policies.
- Maximized sales by promoting storage solutions and related services to prospective customers.
- Maintained accurate records of customer accounts, facility inventory, and operational documentation.
- Handled customer inquiries and resolved complaints professionally, ensuring a positive customer experience.
- Ensured facility security by monitoring surveillance systems and performing regular audits of storage units.
Bookkeeper/Front End
Winn Dixie
01.2011 - 01.2014
- Managed daily cash flow by reconciling cash registers, processing deposits, and ensuring accurate accounting records.
- Handled bookkeeping tasks, including tracking transactions, preparing financial reports, and maintaining store budgets.
- Provided excellent customer service by addressing customer inquiries, resolving issues, and ensuring satisfaction at the checkout.
- Supervised and trained front-end staff, ensuring compliance with company policies and maintaining operational efficiency.
- Operated point-of-sale systems, processed transactions accurately, and ensured proper handling of cash, credit, and coupons.
- Assisted with inventory management, including tracking stock levels and processing product returns.
- Maintained a clean, organized, and welcoming front-end area to enhance the customer experience.
Education
Registered Nurse -
Florida National University
01.2022
Registered Behavior Technician -
01.2020
High School - undefined
Felix Varela High School
01.2011
Skills
- Bilingual
- Good Communication skills
- Critical thinking and problem solving
- Time management
- Attention detail
- Team work and leadership
- Data management
- Project management
Training
- HIPPA
- CGP
- OSHA
- IATA
- CPR/ First Aid
Timeline
Lead Research Coordinator/Regulatory
Bio Research Partner
10.2024 - Current
Lead Research Coordinator/Regulatory
PharmaDev Research
01.2024 - 10.2024
Clinical Research Coordinator
Miami Clinical Research
11.2019 - 10.2023
Clinical Research Coordinator/Regulatory
Lcc Medical Research
01.2015 - 11.2019
Relief Manager
Public Storage
01.2014 - 01.2015
Bookkeeper/Front End
Winn Dixie
01.2011 - 01.2014
High School - undefined
Felix Varela High School
Registered Nurse -
Florida National University
Registered Behavior Technician -
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