Summary
Work History
Education
Skills
Clinical Trial Experience
Emergency Medicine
Timeline
Generic

Brandi Merchant

Ocala,FL

Summary

Detail-oriented Research Nurse and Clinical Coordinator with expertise in HIPAA, GCP, ICH, and FDA compliance. Delivers effective project management and quality assurance for safe, efficient clinical studies. Proficient in chart review, source document control, and communication with sponsors and care teams. Experienced in developing care plans and educating patients and families, ensuring a patient-centric approach to healthcare.

Work History

Nurse

Maxim Healthcare
Ocala, Florida
2010 - 2011
  • Delivered patient care for Maxim Healthcare clients in home and facility settings.
  • Administered medications and monitored patient responses under physician care plans.
  • Recorded vital signs and documented assessments in patient charts.
  • Assisted with wound care, dressing changes, and infection control practices.
  • Communicated patient status updates with families, nurses, and care teams.
  • Prepared treatment supplies and supported daily nursing procedures.
  • Followed care plans and adjusted support based on patient needs.
  • Maintained safe environments and followed Maxim Healthcare clinical standards.

Research Nurse - Quality Assurance Dept.

Renstar Medical Research
Ocala, Florida
2001 - 2005
  • Monitored patient safety and reported adverse events to study teams
  • Supported regulatory compliance through chart review and protocol documentation
  • Ensured compliance with applicable regulations such as HIPAA, GCP and ICH guidelines, FDA rules.
  • Prepared IRB submissions for new projects or renewals of existing projects.
  • Prepared source documents and maintained accurate research nurse records
  • Maintained detailed records of participant information, including medical histories and lab results.

Director, Clinical Research

Research Associates
Ocala, Florida
1998 - 2000
  • Directed Clinical Research programs for Research Associates across study sites and teams.
  • Oversaw protocol development, review, and clinical trial execution for Research Associates’s studies.
  • Coordinated communication and collaboration among investigators, sponsors, and vendors to enhance efficiency in Research Associates' research activities.
  • Managed regulatory submissions, IRB documents, and compliance records for clinical studies.
  • Reviewed study data, source documents, and case report forms for accuracy.
  • Led staff training on GCP standards, study procedures, and research policies.
  • Monitored and managed budgets, timelines, and resource plans to ensure successful execution of Research Associates clinical projects.
  • Guided issue resolution, risk tracking, and process improvements across research operations.
  • Analyzed results from completed studies to determine areas needing improvement.
  • Conducted quality assurance reviews to ensure the accuracy of data collected from each site participating in a study program.
  • Monitored progress of all clinical studies to ensure compliance with applicable regulations and guidelines.
  • Developed and delivered presentations on study results at national conferences to disseminate findings and promote research initiatives.
  • Organized periodic meetings with investigators to assess progress on ongoing studies.
  • Ensured that safety standards were met in accordance with ICH-GCP guidelines during all phases of the study process.
  • Coordinated recruitment efforts for clinical trials by developing strategies and working closely with investigators.
  • Participated in meetings with potential sponsors to discuss their needs regarding clinical research services offered by the organization.
  • Collaborated with multidisciplinary teams consisting of physicians, nurses, statisticians and other professionals involved in conducting research studies.
  • Recruited, hired and trained new medical and facility staff.
  • Led, managed, and assessed performance of medical, clerical, and maintenance staff to ensure operational effectiveness. medical, clerical or maintenance personnel.

Certified Clinical Research Coordinator-Nurse

MediQuest Research Group
Ocala, Florida
1993 - 2000
  • Coordinated MediQuest Research Group study visits and participant schedules.
  • Managed recruitment efforts for clinical trials, enhancing participant enrollment through targeted advertising and efficient screening processes, including advertising, screening and enrollment of participants in clinical trials.
  • Screened volunteers for protocol eligibility and study criteria.
  • Obtained informed consent and explained study procedures clearly.
  • Assisted in the preparation of informed consent forms and other trial-related documentation.
  • Collected source documents and maintained accurate clinical records.
  • Entered data into EDC systems and verified chart completeness.
  • Monitored adverse events and communicated findings to study staff, facilitating timely response and participant safety.
  • Prepared regulatory binders and organized IRB submission materials.
  • Maintained regulatory documents and ensured compliance with applicable regulations.
  • Participated in Clinical Study Team meetings as requested by Sponsor or Principal Investigator.
  • Developed study timelines and tracked progress against the timelines.
  • Attended Investigator Meetings both locally and nationally to support ongoing studies.
  • Collaborated closely with other departments within the organization such as Regulatory Affairs, Data Management, Biostatistics and Quality Assurance.
  • Conducted protocol-specific training for research personnel.
  • Provided guidance to research team members on best practices related to clinical research operations processes and procedures.
  • Communicated effectively with sponsors regarding status updates on active studies.
  • Reviewed protocols to ensure that all necessary information is collected during the course of a study.
  • Interacted with clinical staff to ensure accurate collection and reporting of data related to clinical studies.
  • Identified areas for improvement within current operational processes through root cause analysis.
  • Prepared detailed reports summarizing study results for internal review boards and external agencies, ensuring compliance with regulatory requirements.
  • Provided technical assistance in developing SOPs related to clinical research operations process.
  • Performed quality control reviews of databases prior to database lock or submission to the sponsor or regulatory agency.
  • Performed quality control reviews of databases prior to database lock or submission to sponsor or regulatory agency.

Research Assistant

MediQuest Research Group
Ocala, Florida
1990 - 1993
  • Collected research data from patient records and source documents.
  • Reviewed data entries for accuracy and completeness.
  • Collaborated with other researchers in developing study designs, methods, and tools for data collection.
  • Supported clinical study coordination at MediQuest Research Group.
  • Monitored sample handling procedures to ensure proper protocols were followed. and document submissions.
  • Prepared materials for investigator meetings and study reviews.
  • Prepared comprehensive reports summarizing research findings.
  • Prepared reports, presentations, and articles using Microsoft Word and PowerPoint.
  • Participated in team meetings to discuss progress on ongoing projects or brainstorm ideas for future endeavors.
  • Maintained a database of all research activities conducted during the course of each project.

EKG Technologist

MRMC Heart Center
Ocala, Florida
1990 - 1992
  • Monitored cardiac rhythms during procedures and promptly reported abnormal readings to support timely medical intervention.
  • Placed electrodes and verified lead placement accuracy to ensure reliable ECG tracings.
  • Performed resting EKGs for cardiac patients at heart center.
  • Documented EKG results in patient charts and EMR systems to maintain accurate and comprehensive patient records.
  • Ensured all equipment was properly maintained and calibrated according to established guidelines.

Cardiac Catheterization Lab Unit Secretary/Transcriptionist

MRMC
Ocala, Florida
1989 - 1990
  • Managed patient charts and unit records for MRMC hospital staff.
  • Managed incoming phone calls, directed them to appropriate personnel, and relayed messages to nurses and physicians.
  • Answered telephone calls promptly and directed them to appropriate personnel or departments.
  • Prepared admission paperwork and updated patient information in records.
  • Scheduled patient transports and coordinated unit appointments.
  • Scheduled diagnostic tests and procedures for patients according to established protocols.
  • Transcribed doctors' orders, including medication and lab test requests.
  • Collected and organized physicians' paperwork for review, including lab test requests, ensuring timely access to essential information.
  • Communicated test results and requests between care teams.
  • Organized and filed medical documents and department correspondence for efficient retrieval.
  • Prepared documents for signature by physicians or other authorized personnel.
  • Provided clerical support including filing, faxing, photocopying and data entry of patient information into electronic health record systems.
  • Coordinated with other departments to ensure timely delivery of services to patients.
  • Assisted visitors with directions and unit information at MRMC.
  • Organized laboratory specimens for pickup by courier service.

Speech and Hearing Unit Secretary

MRMC
Ocala, Florida
1988 - 1989
  • Coordinated unit communications for MRMC hospital staff, patients, and visitors.
  • Maintained patient charts and records using MRMC clerical procedures.
  • Scheduled appointments and updated unit calendars for MRMC departments.
  • Answered incoming calls and routed messages to proper MRMC staff.
  • Filed confidential documents and protected patient information under MRMC standards.
  • Provided clerical support including filing, faxing, photocopying and data entry of patient information into electronic health record systems.
  • Responded to requests from internal staff regarding patient information in accordance with HIPAA regulations.
  • Maintained patient records, medical histories, test results and other pertinent information in the hospital's computer system.

Education

LPN-BSN Exams - Nursing

Excelsior College
Albany, NY

AS-Pre Nursing LPN-ADN - Health Sciences And General Education

College of Central Florida
Ocala, FL
01-1997

LPN - Practical Nursing-Health Sciences

College of Central Florida
Ocala, FL
12-1993

EMT - Health Sciences

College of Central Florida
Ocala, FL
12-1992

Skills

  • Clinical research coordination
  • Attention to detail
  • EDC management
  • Quality assurance
  • Study documentation
  • Clinical documentation
  • Patient assessment
  • Nursing assessments
  • Patient safety monitoring
  • Patient education
  • Intravenous therapy
  • Care transition planning
  • Patient discharge management
  • Cardiac monitoring
  • Acute care
  • Critical care management
  • Ambulatory care
  • Electronic health records
  • HIPAA compliance
  • Project management
  • Time management
  • Team management
  • Team collaboration
  • Attention to detail
  • Critical thinking
  • Effective communication
  • Florida nursing license
  • Clinical judgment
  • Acute care
  • Florida nursing license

Clinical Trial Experience

  • Worked on numerous Phase I-IV Device and Pharmaceutical trials in the areas of Emergency Medicine, Interventional Cardiology, Cardiology, Infectious Disease and Neurology. Led enrollment as the top enroller for the TIMI Study Group trials with Dr. Robert Feldman and MediQuest Research Group in Ocala, FL as well as others such as the HIRULOG, SCORES and BOAT trials.
  • Prepared for and successfully led MediQuest Research Group thru a random FDA audit for the SCORES trial.

Emergency Medicine

  • Assisted in the creation of Pre-hospital Treatment for Myocardial Infarction and Stroke protocol for MRMC Emergency Dept and Ambulance Service.

Timeline

Nurse

Maxim Healthcare
2010 - 2011

Research Nurse - Quality Assurance Dept.

Renstar Medical Research
2001 - 2005

Director, Clinical Research

Research Associates
1998 - 2000

Certified Clinical Research Coordinator-Nurse

MediQuest Research Group
1993 - 2000

Research Assistant

MediQuest Research Group
1990 - 1993

EKG Technologist

MRMC Heart Center
1990 - 1992

Cardiac Catheterization Lab Unit Secretary/Transcriptionist

MRMC
1989 - 1990

Speech and Hearing Unit Secretary

MRMC
1988 - 1989

LPN-BSN Exams - Nursing

Excelsior College

AS-Pre Nursing LPN-ADN - Health Sciences And General Education

College of Central Florida

LPN - Practical Nursing-Health Sciences

College of Central Florida

EMT - Health Sciences

College of Central Florida

Similar Profiles

  • Mrs.Halima.M MwaisunguMrs.Halima.M Mwaisungu

    Clinical reserach ethics Nurse at Catholic University of Health nad Allied Sciences- Bugando Medical Centre (BMC)Clinical reserach ethics Nurse at Catholic University of Health nad Allied Sciences- Bugando Medical Centre (BMC)

  • HARJANET BEDIHARJANET BEDI

    Registered Nurse II – Telemetry / Medical-Surgical at Kaiser PermanenteRegistered Nurse II – Telemetry / Medical-Surgical at Kaiser Permanente

  • Brian KenyaBrian Kenya

    Clinical Registered Nurse at Emory Healthcare SystemsClinical Registered Nurse at Emory Healthcare Systems

  • TEMITOPE ISADARETEMITOPE ISADARE

    Registered Nurse (New Grad Residency Program) at HMH JFK University Medical CenterRegistered Nurse (New Grad Residency Program) at HMH JFK University Medical Center

CREATE PROFILE
Brandi Merchant