Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Latreina Koonce

New Bern

Summary

Professional with 8+ years experience in clinical research coordination, equipped to make significant impact in this field. Demonstrated ability to manage clinical trials, ensure compliance with protocols, and maintain accurate documentation. Strong emphasis on team collaboration, reliability, and adaptability to evolving project requirements. Proficient in patient recruitment, data collection, and regulatory submissions, with results-driven approach that ensures successful study outcomes.

Overview

19
19
years of professional experience
1
1
Certification

Work History

Clinical Research Coordinator

Centricity Research/Lucas Research
07.2023 - Current
  • 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.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
  • Developed and maintained accurate and up-to-date case report forms and source documents.
  • Prepared and maintained regulatory documents for clinical trial submissions.
  • Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
  • Maintained accurate and up-to-date case report forms and source documents for traceability.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
  • Prepared detailed informed consent documents to clearly communicate risks, benefits, expectations, rights and responsibilities related to participation in clinical trials.
  • Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
  • Streamlined data collection processes for increased efficiency and accuracy in study results.
  • Directed site initiation visits, establishing key partnerships with local healthcare providers to facilitate successful trial implementation.
  • Streamlined patient visit schedules, reducing wait times and increasing patient satisfaction.
  • Conducted comprehensive reviews of clinical trial protocols to identify and rectify potential issues before study initiation.
  • Led cross-functional team meetings to discuss trial progress and address any challenges, fostering collaborative work environment.
  • Coordinated with multiple departments to ensure compliance with regulatory standards, leading to successful trial audits.
  • Improved trial visibility and public interest through effective community outreach and education initiatives.
  • Monitored adverse events and ensured timely reporting to regulatory bodies, maintaining high safety standards.
  • Oversaw ethical conduct of clinical trials, ensuring all activities were in accordance with ethical guidelines.
  • Improved data integrity and accuracy with meticulous oversight of data collection processes.
  • Facilitated communication between research team and study sponsors, ensuring clear and consistent updates on trial progress.
  • Enhanced patient enrollment in clinical trials by developing and implementing effective recruitment strategies.
  • Complied with research protocols by providing ongoing quality control audits.
  • Collected, evaluated, and modeled collected data.
  • Reviewed referral information and kept track of intakes from various referral sources.
  • Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.

Travel Clinical Research Coordinator

Care Access Research
09.2022 - 04.2023
  • Decentralized Trials onsite/remote
  • 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.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
  • Developed and maintained accurate and up-to-date case report forms and source documents.
  • Prepared and maintained regulatory documents for clinical trial submissions.
  • Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
  • Maintained accurate and up-to-date case report forms and source documents for traceability.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Prepared detailed informed consent documents to clearly communicate risks, benefits, expectations, rights and responsibilities related to participation in clinical trials.
  • Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
  • Streamlined data collection processes for increased efficiency and accuracy in study results.
  • Streamlined patient visit schedules, reducing wait times and increasing patient satisfaction.
  • Monitored adverse events and ensured timely reporting to regulatory bodies, maintaining high safety standards.
  • Conducted site visits to monitor trial conduct and provide on-site support, ensuring high-quality data collection.
  • Oversaw ethical conduct of clinical trials, ensuring all activities were in accordance with ethical guidelines.

Clinical Research Study Coordinator

Eastern Nephrology Associates
04.2017 - 09.2022
  • Evaluated potential risks associated with each study proactively addressing any concerns or issues before they arose.
  • Improved data quality with meticulous attention to detail and thorough documentation.
  • Facilitated smooth communication between researchers, participants, and external partners through proactive engagement and prompt responses to inquiries.
  • Maintained up-to-date knowledge of industry trends and regulatory requirements ensuring that studies were compliant at all times.
  • Enhanced participant retention by developing and implementing effective communication strategies.
  • Ensured compliance with ethical guidelines, maintaining the highest standards of confidentiality and privacy for all participants.
  • Trained new team members on study procedures, enhancing their understanding of project goals and expectations.
  • Actively participated in continuing education opportunities refining skills as a Research Study Coordinator.
  • Organized regular team meetings for efficient coordination among colleagues leading to improved collaboration.
  • Provided vital support during data analysis phases by reviewing findings for accuracy before final reporting.
  • Managed subject recruitment efforts, resulting in a diverse and representative participant pool.
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • 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.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Followed informed consent processes and maintained records.
  • Gathered, processed, and shipped lab specimens.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Maintained accurate and up-to-date case report forms and source documents for traceability.
  • Prepared and maintained regulatory documents for clinical trial submissions.
  • Complied with research protocols by providing ongoing quality control audits.
  • Collected, evaluated, and modeled collected data.
  • Reviewed referral information and kept track of intakes from various referral sources.

Certified Clinical Hemodialysis Technician

Fresenius Medical Center
06.2015 - 03.2020
  • Minimized complications related to vascular access sites by performing proper cannulation techniques using both needles and catheters according to established protocols.
  • Reduced the risk of infections by adhering to strict infection control protocols during all procedures.
  • Demonstrated excellent teamwork skills while assisting other technicians during busy shifts for optimal patient care delivery.
  • Explained dialysis procedures to patients and answered questions and concerns prior to starting dialysis.
  • Assisted patients with their pre-dialysis weight measurements, ensuring accurate assessment of fluid removal needs during the procedure.
  • Enhanced patient care by providing efficient and accurate hemodialysis treatments.
  • Measured and recorded patients' pre-dialysis and post-dialysis vital statistics.
  • Cleaned and connected fistulas, grafts and catheters to prevent infection.
  • Promoted continuity of care by documenting detailed treatment records in electronic health systems for easy access by all healthcare providers involved in the patient''s care plan.
  • Set-up equipment for dialysis and primed dialyzer in preparation for use.
  • Started and ended reverse osmosis water systems and completed water quality monitoring tests.
  • Completed required training courses on time, staying up-to-date with industry best practices and advancements in dialysis technology for improved patient outcomes.
  • Demonstrated adaptability and flexibility when faced with unexpected challenges during a shift, using critical thinking skills to find effective solutions that maintained high-quality patient care standards.
  • Improved clinic workflow by maintaining clean and organized workstations, minimizing downtime between patients.
  • Increased patient satisfaction through compassionate communication and attentive listening to their concerns or questions regarding treatment plans.
  • Supported interdisciplinary team collaboration by sharing relevant patient information with physicians, nurses, and dietitians for comprehensive care planning.
  • Performed routine quality control and safety checks on all equipment.
  • Optimized treatment efficiency through regular equipment maintenance checks, ensuring all machines were in proper working order prior to initiating dialysis sessions.
  • Assisted in the training and onboarding of new technicians, sharing valuable knowledge from personal experience to help them quickly become proficient contributors within the clinic team.
  • Ensured quality treatment outcomes by closely monitoring patient vital signs and adjusting machine settings as needed.
  • Contributed to a safe care environment through timely identification and reporting of equipment malfunctions or defects.
  • Promoted overall clinic success by contributing ideas during staff meetings for process improvements or ways to enhance patient experience while receiving care at our facility.
  • Maintained compliance with state regulations governing clinical practice, adhering to organizational policies and procedures at all times during service provision.
  • Facilitated smooth transitions between shifts through thorough handover reports highlighting key aspects of each patient's condition and treatment progress.
  • Improved patient safety by keeping up-to-date with emergency protocols and participating in routine drills simulating various scenarios that could arise during the course of hemodialysis treatments.
  • Supported a welcoming atmosphere within the clinic by engaging in positive interactions with patients' family members or caregivers when appropriate, fostering strong relationships that ultimately benefit overall treatment experience for patients themselves.
  • Set up and operated dialysis machines for patients receiving treatment for kidney failure.
  • Followed directions when mixing dialysate and priming dialyzer with saline or heparinized solutions.
  • Explained dialysis procedures and hemodialysis machine operation to patients prior to treatment to ease anxieties.
  • Safely transported, transferred and positioned patients on chairs for treatment.
  • Inventoried, ordered and restocked equipment and supplies needed for hemodialysis treatment.
  • Cleaned and sterilized instruments, equipment and surfaces.
  • Educated patients about procedures, answered questions, and provided comforting words to control anxiety and enhance procedure results.
  • Cared for patients by providing personal assistance and ambulation.
  • Monitored patient vital signs, lab results and other indicators of health.
  • Participated in hospital and clinic staff meetings to discuss patient care.
  • Maintained accurate patient charts and medical records.
  • Utilized medical software to document and track patient progress.
  • Operated and maintained medical equipment used to diagnose and treat patients.

General Manager

Dunkin Donuts
03.2012 - 06.2015
  • Managed budget implementations, employee reviews, training, and schedules
  • Reduced costs, managed delivery schedules and performed risk analysis to improve overall profitability
  • Developed and maintained relationships with customers and suppliers through account development
  • Maximized efficiency by coaching and mentoring personnel on management principles, industry practices, company procedures and technology systems
  • Implemented operational strategies and effectively built customer and employee loyalty
  • Set, enforced and optimized internal policies to maintain responsiveness to demands
  • Assessed reports to evaluate performance, develop targeted improvements and implement changes
  • Enhanced operational efficiency and productivity by managing budgets, accounts and costs
  • Delivered business strategy and developed systems and procedures to improve operational quality and team efficiency
  • Reduced corporate risk by managing shrink processes and controlling inventory levels
  • Applied performance data to evaluate and improve operations, target current business conditions and forecast needs
  • Developed effective business plans to align strategic decisions with long-term objectives
  • Assessed supplier quality to maintain tight cost controls and maximize business operational performance

Certified Nursing Assistant

Pruitt Health
11.2005 - 12.2010
  • Answered call lights and supported patient comfort and safety by adjusting bed rails and equipment
  • Provided high-quality personal care services such as bathing, grooming, dressing, and feeding to ensure patient dignity.
  • Checked patient vitals such as temperature, blood pressure and blood sugar levels
  • Assisted with feeding and monitored intake to help patients achieve nutritional objectives
  • Delivered individualized patient care by recording vital signs, documenting observations, administering treatments and evaluating patient needs
  • Cared for residents in assisted living facility and long term care facility and delivered high-quality support to meet needs
  • Evaluated patients to identify and address wounds, behavioral concerns and medically relevant symptoms
  • Cared for clients with diagnoses such as respiratory failure, diabetes, Parkinson's disease and muscular dystrophy etc
  • Supported ambulation and physical therapy needs by conducting planned exercise routines
  • Oversaw and maintained patients' rooms, group living areas and nurse stations
  • Assisted in personal hygiene management, feeding and ambulation
  • Maintained patient stability by checking vital signs and weight and recording intake and outtake information
  • Reduced risks of patient infection and cross-contamination by cleaning and sterilizing equipment
  • Maintained best-in-class standards for individualized care in 60-bed unit by continuously checking in with patients and families and quickly providing care

Education

No Degree - Health Information Technology

Craven Community College
New Bern, NC

Associate of Science - Clinical Research

Pamlico Community College
Grantsboro, NC
05.2023

High School Diploma -

West Craven High School
Vanceboro, NC
05.2002

Skills

  • Clinical Trials and Research
  • Research and Data Management
  • Informed Consent
  • Research SOP Understanding
  • Clinical Data Collection
  • Specimen Collection
  • Medidata Rave
  • Specimen Handling
  • Study Coordination
  • Medication Dispensing
  • Documentation Requirements
  • Site Visits/Monitoring
  • Dispensing Oversight
  • Laboratory Results Management
  • Study Protocols
  • Drug Storage Procedures
  • Prospective Studies
  • Quality Control Procedures
  • Patient Safety
  • Health Research
  • Good Clinical Practices (GCP)
  • Good Documentation Practices (GDP)
  • Case Report Management
  • Infection Control Procedures
  • Decentralized Trials
  • EDC Practice and Management
  • Trial Oversight
  • Regulatory Requirements
  • Study Materials
  • Patient Rehabilitation
  • Team Meetings/Team Building
  • Treatment Plans
  • Treatment Adjustments
  • Client Support
  • Regulatory Knowledge
  • Site Preparation
  • Quality Improvement Plans
  • Medical Histories and Vital Statistics
  • Customer Satisfaction
  • Quality Patient Care
  • Research Protocol Development
  • Respiratory Disorders
  • Medical Device Trials
  • Data Collections
  • Medication Side Effect Knowledge
  • Lab Specimens and Collections
  • Site Investigation Reports
  • Product Inventories
  • Precautionary Measures
  • Complex Problem-Solving
  • Informed Consent Procedures
  • Monitoring Visits
  • Medical Records Evaluation
  • Creative Thinking
  • Atrial Fibrillation
  • Data Organization
  • Problem Resolution
  • Workflow Management
  • Phlebotomy

Certification

Certified Clinical Hemodialysis Technician, Fresenius Medical Center, 2016-present

Timeline

Clinical Research Coordinator

Centricity Research/Lucas Research
07.2023 - Current

Travel Clinical Research Coordinator

Care Access Research
09.2022 - 04.2023

Clinical Research Study Coordinator

Eastern Nephrology Associates
04.2017 - 09.2022

Certified Clinical Hemodialysis Technician

Fresenius Medical Center
06.2015 - 03.2020

General Manager

Dunkin Donuts
03.2012 - 06.2015

Certified Nursing Assistant

Pruitt Health
11.2005 - 12.2010

Associate of Science - Clinical Research

Pamlico Community College

High School Diploma -

West Craven High School
Certified Clinical Hemodialysis Technician, Fresenius Medical Center, 2016-present

No Degree - Health Information Technology

Craven Community College
Latreina Koonce