Gigi Benoit
Clinical Research Coordinator
D'Iberville,MS
Summary
Diligent professional with comprehensive background in coordinating clinical research studies, equipped to make significant impact in this field. Successfully managed multiple clinical trials from initiation to closeout, ensuring adherence to regulatory and protocol - specific guidelines. Demonstrated ability to effectively communicate with cross-functional teams and maintain meticulous documentation. Proficient in patient recruitment, data collection, and regulatory submissions, with results-driven approach that ensures successful study outcomes.
Overview
6
6
years of professional experience
Work History
Clinical Research Coordinator
Velocity Clinical Research
09.2018 - 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.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- 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.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- 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.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- 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.
- 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.
- Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
- Streamlined data collection processes for increased efficiency and accuracy in study results.
- Led cross-functional team meetings to discuss trial progress and address any challenges, fostering collaborative work environment.
- Developed training materials for new staff members, enhancing team competence and efficiency in clinical trial operations.
- Facilitated communication between research team and study sponsors, ensuring clear and consistent updates on trial progress.
- Facilitated successful trial completion by closely monitoring study timelines and milestones, ensuring on-time delivery of results.
- Oversaw ethical conduct of clinical trials, ensuring all activities were in accordance with ethical guidelines.
- Monitored adverse events and ensured timely reporting to regulatory bodies, maintaining high safety standards.
- Complied with research protocols by providing ongoing quality control audits.
Education
Associate of Arts - Pre B. S. Nursing
Mississippi Gulf Coast Community College
Gautier, MSBachelor of Science - Psychology, Biology
William Carey University
Hattiesburg, MSSkills
- Management of Clinical Trials
- Regulatory Standards Knowledge
- Facilitating Informed Consent
- Risk Monitoring Proficiency
- GCP Standards Adherence
- Workforce Skill Enhancement
- Research Coordination
- Multifunctional Partnership
- Quality Assurance
- Concise Information Delivery
- Record Management
- Clinical Product Oversight
- Medication Distribution
- Biological Sample Management
- Medication Distribution Oversight
Timeline
Clinical Research Coordinator
Velocity Clinical Research
09.2018 - Current
Associate of Arts - Pre B. S. Nursing
Mississippi Gulf Coast Community College
Bachelor of Science - Psychology, Biology
William Carey University
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