NORTORIOUS COLEMAN-TAYLOR, MS,MSCR

• Led and participated in client audit preparation, hosting, and follow-up.
• Hosted 49 sponsor qualification audits in last 18 months in QA role, with seven that had no findings reducing post-audit costs to use resources to respond to audit findings.
• Supported identifying and implementing continuous improvement opportunities and initiatives by refining SOPs governing clinical and quality operations.
• Assisted with creation and execution of internal clinical quality audit plans. Conduct and participate in internal audits of Science 37 cGXP Departments (e.g., Clinical Operations, Nursing Solutions, Medical Affairs) and functional group areas and processes.
• Streamlined and maximized audit readiness process
  Proposed development and testing improvements to positively impact usability, function, and performance.
  Met tight deadlines to satisfy client demands and project timelines.
• Developed quality assurance plans by conducting gap and risk analyses.
• Monitored activities and supporting systems to meet compliance regulations.
• Resolved issues efficiently and built excellent client rapport, which enhanced customer satisfaction ratings.
• Maintained frequent interaction with senior management to measure goal achievement and determine areas of improvement.
• Managed large-scale projects and introduced new systems, tools, and processes to achieve challenging objectives.
• Developed proposals and presentations for internal and external audiences.
• Developed and implemented new filing systems to improve organizational efficiency and productivity.
• Evaluated hiring, firing, and promotions requests.

• Supported identification and implementation of continuous improvement opportunities and initiatives
• Expanded cross-functional organizational capacity by collaborating on priorities, functions, and shared goals across departments.
• Assisted with development and refinement of SOPs governing clinical and quality operations
• Executed internal clinical quality audit plans
• Supported deviation and CAPA investigations and resolution
• Participated in client audit preparation, hosting, and follow-up, including support of “staging room.”
• Conduct and participate in internal audits of Science 37 Clinical Operations, Data Management, Investigative Product, and Nursing
• Remain abreast of current regulations and industry best practices in clinical trials
• Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
• Used critical thinking to break down problems, evaluate solutions and make decisions.
• Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
• Promoted awareness of project-specific quality and performance standards to support documentation, communication, and understanding.
• Adhered to procedures, practices, and regulatory requirements to maintain health, safety, and environmental compliance.
• Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
• Reviewed clinical data, source documentation, case report forms, and investigative site regulatory files to verify accuracy and completion.
• Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
• Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
• Assessed investigation reports of subordinate quality assurance personnel and addressed any procedural deviations.

• Functioned as clinical research coordinator and In-House Clinical Research Associate (CRA) for multitude of decentralized clinical research trials
• Managed 7 satellite sites for diagnostic clinical trial
• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Managed and screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations.
• Validated incoming data to check information accuracy and integrity while independently locating and correcting concerns.
• Recorded data and maintained source documentation following good documentation practices.
• Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
• Liaised with clinical project manager to effectively resolve study-related issues.
• Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
• Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
• Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Followed informed consent processes and maintained records.
• Maintained compliance with protocols covering patient care and clinical trial operations.
• Participated in initiation visits and investigator meetings, implementing trials per study timelines and budgets.
• Prepared variety of different written communications, reports, and documents.
• Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.

• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Gathered, processed, and shipped lab specimens.
• Coordinated clinical trials focused on overactive bladder, Vaginal Prolapse, Urinary Microbiome, and Urogynecology disorders.
• Participated in initiation visits and investigator meetings, implementing trials per study timelines and budgets.
• Built, maintained, and executed development on electronic databases and e-Consents utilizing REDCap.
• Increased recruitment and attrition in satellite smaller sites by 150%.

• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Orchestrated smooth and efficient program development by collaborating cross-functionally across departments.
• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
• Monitored unit budget to meet financial objectives for spending rate and funding.
• Gathered, processed, and shipped lab specimens.
• Worked closely with Principle Investigator to maintain optimum levels of communication to effectively and efficiently complete projects.
• Drove operational improvements, which resulted in savings and improved profit margins.
• Screen, schedule, consent, and collect adverse events (AE) information for participants in various clinical research studies.
• Maintains subject-level documentation, including documentation of consent in electronic medical record.
• Prepare documents, equipment, or supplies for research visits.
• Conduct and document visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for all types of studies independently.
• Employ strategies to maintain recruitment and retention rates and to assist participants with individual needs.
• Evaluate processes to identify issues related to recruitment and retention rates.
• Maintain familiarity with ethical conduct of research and safeguards needed when conducting research.
• Trained junior staff in ethical conduct of research.
• Helped to design studies to include specific safeguards to ensure ethical conduct and protect vulnerable populations.
• Initiate and maintain accurate and comprehensive documentation as required by FDA, Institutional Review Board, study sponsors, and Good Clinical Practice Guidelines in connection with research trials.
• Prepares protocols, consent forms, audit forms, study amendments, continuing reviews, recruitment reports, adverse events, and any other information needed by IRB or study sponsor.
• Manages day-to-day running of three NCI-funded research protocols in Smoking Cessation Tobacco Treatment Program.
• Created and maintained REDCap databases housing data collections of research studies across multiple sites.
• Prepare reports on research participants’ status, track activities as required, and present information to research team at meetings.
• Monitor study documentation for compliance with protocols, standard operating procedures (SOPs), and federal, state, and local regulations. For safety and effectiveness of research, protocol.
• Recruit and retain adult research participants who require initiating and maintaining good rapport with participants.
• Traveled to patients to collect data and biochemical verification of smoking cessation.
• Observed study enrollment rates and assisted with implementing techniques to maximize enrollment rates.
• Organized and managed program development from conception through successful execution.
• Maintained tight production timetables and quality standards to give audiences exceptional offerings.
• Managed team of 4 researchers
• Managed study database of six studies with aggregate of 800 subjects
• Eliminated downtime and maximize revenue by providing top-project quality control

• Similar tasks to position below include organized and managed program development from conception through successful execution.
• Managed day-to-day running of research protocols in Clinical Neuroscience Division and Ralph H. Johnson Veterans Administration Medical Center.
• Managed data collection of two distinct subject groups and entry functions into VA VINCI systemic database.
• Performed diagnostic interviews consisting of structured clinical interviews such as Addiction Severity Index (ASI) MINI International Neuropsychiatric Interview, Montreal Cognitive Assessment, Timeline Follow Backs, and other related instruments.
• Document participant assessment data in research records.
• Performed Drugs Tests and breathalyzers on research participants.
• Coordinated 4 cohorts of research participant sessions simultaneously.

• Managed two studies
• Participated in preparation and management of research budgets and monetary disbursements.
• Educated patients regarding all facets of clinical study participation.
• Informed patients or caregivers about study aspects and outcomes to be expected.
• Coded, evaluated or interpreted collected study data.
• Monitored study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
• Maintained required records of study activity, including case report forms, drug dispensation records, or regulatory forms.
• Communicated with laboratories or investigators regarding laboratory findings.
• Recruited and screened potential research participants.
• Enrolled and consented pediatric adolescents
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Demonstrated advanced knowledge of federal regulatory compliance guidelines.
• Maintained compliance with protocols covering patient care and clinical trial operations.
• Gathered, processed, and shipped lab specimens.
• Followed informed consent processes and maintained records.
• Maintained detailed records of test results by entering data and patient information into computer.
• Implemented care and efficiency improvements to support and enhance office operations.

• Managed classroom and provided instructions according to plans as prepared by the classroom teacher.
• Took over the class as a regular classroom teacher, managing assignments, student needs, and recordkeeping.
• Composed own lesson materials to implement in a classroom.
• Provided a classroom environment that promoted active learning.
• Worked with students to help reinforce learning objectives.
• Upheld classroom routines to support student environments and maintain consistent schedules.
• Followed classroom plans left by the class teacher to continue student education and reinforce core concepts.
• Utilized technology to enhance student education and grasp of materials.
• Kept students on task with proactive behavior modification and positive reinforcement strategies.

• Taught my peers biochemistry, gene expression, and nucleic acids in small group sessions.
• Recommended students for programs to enhance academic support through improved learning strategies.
• Led discussions and activities centered around course content.
• Evaluated and revised lesson plans and course content to facilitate and moderate classroom discussions and student-centered learning.
• Applied various teaching aids to minimize learning gaps and effectively instruct and motivate students.
• Projected high achievement levels to increase continued student enrollment.

• Representative for Quality Education as a Civil Right (QECR).
• Trained staff members on the current curriculum.
• Modified curriculum based on observations and participants’ mathematical level.
• Assisted in organizing program proposals and budget plans.
• Planned and monitored the implementation of technology-based learning programs.
• Created curricula and research topics and conceptualized course format, subject matter, and presentation.
• Teamed with subject matter experts to evaluate and revise training tools to continually improve learning platforms.

Graduated Cum Laude

Masters Thesis Mentors: Dr. Cassandra Salgado, MD/MSCR & Dr. J. Michael Kilby, MD

• Epidemiology based HIV/AIDS Research:
• Geo-Mapping the HIV community Viral load in Charleston, SC

Graduated Cum Laude

Dissertation Research Mentor: Dr. Jacqueline McGinty, PhD

• Research on cocaine addiction relapse behavior
• Utilized brain-derived neurotrophic factor (BDNF) to study the effects of preventing long- term cocaine-induced neuroadaptations

Graduated Cum Laude