Kewounie N. Bennett
Columbus,GA
Summary
Experienced managing large-scale projects and driving success through effective planning and execution. Utilizes strong organizational and leadership skills to ensure project milestones are met—track record of leveraging communication and problem-solving abilities to achieve project goals.
Overview
10
10
years of professional experience
Work History
Sr. Project Specialist
Syneos Health
03.2022 - Current
- Complete site file reviews of several sponsors in numerous counties for global trials by ensuring all documents are completed per ALCOA/CEA standards and conducting quality checks. Conduct quality assurance reviews on project deliverables to ensure compliance with company standards.
- Provides support in creating the Trial Master File (TMF) and Investigator site files; assists with maintenance tasks such as tracking and filing for the project's duration and preparing for audits and archiving.
- Assists with the ongoing management of the TMF, ensuring documents are filed appropriately, performs TMF file reviews and reconciliation, creates and tracks TMF action items/findings, and escalates overdue action items, as required.
- Managed project timelines and resources to ensure timely completion of deliverables.
- Resolved issues during projects by coordinating with relevant parties until a satisfactory resolution was achieved.
- Collaborated with cross-functional teams to develop and implement project plans.
- Ensured smooth transitions between phases by effectively handing off tasks from one team member or group to another when appropriate.
- Identified potential risks and developed mitigation strategies to address them.
- Maintained organized documentation repositories for easy access by team members throughout life of project.
- Obtained and analyzed basic reporting metrics.
- Assisted in planning and implementation of projects.
- Managed project documentation and deliverables by version.
Clinical Research Coordinator
Columbus Memory Center
03.2021 - 01.2022
- Assisted in development of informed consent documents for study participants.
- Conducted quality assurance audits of study data to ensure accuracy and integrity.
- Trained site staff on protocol procedures and good clinical practice guidelines.
- Developed study protocols and case report forms for clinical trials.
- Monitored patient enrollment and retention to meet study objectives.
- Managed communication between research sites, sponsors, and regulatory agencies.
- Coordinated with investigators to ensure compliance with study requirements.
- Oversaw study-related worksheets, manuals and other documentation.
- Supervised procedural study components for outlining and enforcing standards of care.
- Managed studies with integrity, keeping protocol and regulatory compliance forefront.
- Screened potential subjects, reviewed medical records and discussed histories with physicians or nurses to determine which individuals should be admitted to each study.
- Coordinated efficient subject enrollment process with completely documented informed consent for each person.
- Protected study results by carefully obtaining and documenting subjects' informed consent.
Sr. Clinical Research Coordinator
Bay Pines Foundation/Bay Pines VA Medical Center
12.2019 - 02.2021
- Developed study protocols and case report forms for clinical trials.
- Prepared and submitted required documentation for institutional review board approval.
- Organized investigator meetings, training sessions, and other events related to clinical studies.
- Monitored patient enrollment and retention to meet study objectives.
- Query resolution across multiple databases (i.e., Inform 6.3, Inform PUB)
- Ensure ICF uses VA language (meaning I must change the entire ICF to add the VA legal language). These changes are tracked on a Word document, and the clean copy is also saved and submitted for IRB Committee Review
- Conduct blood draw or collaborate with the Chief of Pathology/Laboratory for tissue collection slides
- Carefully review the source document to ensure the integrity of the data submitted on Case Report Forms or other data collection tools. Monitor data for missing or inaccurate data and respond to queries.
- Maintained all Regulatory Documents required for paper TMF
Sr Clinical Research Corrdinator
Florida Pediatric Associates/Center for Cough
08.2018 - 12.2019
- Assisted in development of informed consent documents for study participants.
- Prepared and submitted required documentation for institutional review board approval.
- Trained site staff on protocol procedures and good clinical practice guidelines.
- Ensured timely reporting of adverse events or safety concerns to regulatory authorities.
- Identified problems with study protocols and worked with investigators to resolve issues.
- Documented adverse events and data covering side effects, conferring with investigators about reports and working with oversight agencies on management of incidents.
- Prepared protocol worksheets, procedural manuals and other study-related documentation.
- Kept meticulous records for internal and regulatory needs, including drug dispensation and case report forms.
- Monitored active studies to verify compliance with facility's protocols and regulatory standards, helping to protect personnel from legal issues.
- Contributed to successful preparation and management of research budgets and related monetary disbursements.
- Managed studies with integrity, keeping protocol and regulatory compliance forefront.
- Coordinated in-depth screenings of potential subjects with interviews and records reviews.
- Organized and maintained complete records for each study, including the case reports, drug dispensation records and regulatory paperwork.
- Arranged for research study sites and determined staff or equipment availability.
- Oversaw study-related worksheets, manuals and other documentation.
- Conducted quality assurance audits of study data to ensure accuracy and integrity.
Lead Clinical Research Coordinator
Coastal Orthopedics
05.2016 - 08.2018
- Training physicians and other individuals involved in the study to obtain all data needed during operation procedures while in the operating room with the principal investigator and outside sponsors or sales representatives
- Extensive training for all new research coordinators, M.D, physician assistants, and medical assistance
- Conduct site file reviews ensuring ALCOA/CEA compliance and quality checks
- Supported trial management from initiation to closure, enhancing project efficiency
- Maintained Trial Master File and site files, ensuring audit readiness
- Facilitated project system setup and maintenance, optimizing data management
- Coordinated site outreach for feasibility projects, increasing site engagement
- Analyzed project data to identify bottlenecks, implementing strategic solutions that streamlined workflows and enhanced overall project performance
- Introduced novel project management methodologies, resulting in improved resource allocation and accelerated project timelines
- Coordinated clinical trials, enhancing participant engagement and data accuracy
- Managed patient recruitment, achieving target enrollment rates ahead of schedule
- Ensured compliance with protocols, fostering a collaborative research environment
- Analyzed trial data, contributing to improved study methodologies
- Facilitated communication between departments, streamlining project workflows
- Led oncology clinical trials, ensuring protocol compliance and patient safety
- Trained staff on protocol updates, enhancing team efficiency
- Collaborated with investigators to surpass enrollment targets
- Monitored data quality, resolving discrepancies for accurate reporting
- Managed regulatory submissions, maintaining compliance with VA standards
- Coordinate clinical trials, ensuring compliance and efficient data collection
- Improved patient recruitment strategies, enhancing study participation rates
- Utilize analytical skills to interpret complex data and generate actionable insights
- Resolved logistical challenges, optimizing trial timelines and resource allocation
- Facilitated cross-functional team collaboration, driving successful project outcomes
- Reviews and comprehends each assigned protocol, including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protectors
- Travel/provide luncheons to outside medical offices for study participants
- Work closely with Site Monitors for the selection process
- Resolving queries within 72 hr turn around
- Assist CRA (Clinical Research Associates) assigned to the sight with any queries, medical records, medical documentation, etc
- Recruit/consent eligible subjects for participation in research studies
- Assist with explaining how to operate medical devices such as Spinal Cord Stimulator remote controls
- How to navigate the setting control for each lead
- How to navigate pain relief for shoulder repair, hip replacement or knee replacement
- Remote for pain relief w/rotator cuff injuries
- Ensure subjects understood and followed the protocol on the devices
- How to properly wear the medical devices
- Assist orthopedic surgeons (PIs) in surgery for accurate settings/measurements per the protocol, along with the sales representative for the Sponsor
Clinical Research Coordinator
National Institute of Health
06.2014 - 04.2016
- Coordinate patient scheduling, travel, and admissions as designated by clinical trial protocol
- Act as a liaison between participants, participants' relatives, and staff members, communicating participants' questions, complaints, problems, and concerns to appropriate staff members
- Review all documentation of patient medical records, clarify information, and obtain needed documentation
- Participate in clinical documentation improvement clinical rounds
- Prepare protocol tracking data for annual reports and IRB (Central) submissions
- Coordinate NIH resources designated for the Neuroimmunological Diseases Unit (NDU), including use and communication for requirements to different staff groups and departments and Biological Specimen collection and delivery
- Assist clinic in new initiatives and special projects in support of NDU Operations
- Prepares work products and documents related to arranging patient scheduling, travel, and admissions; tracks patient referral process; maintains patients/volunteers' data in the NDU database
- Facilitate work products and documents related to coordinating volunteer payments; prepare, maintain, and fax weekly schedule; prepare documents for clinical protocols in IRB/FDA; maintain protocols files
Education
BACHELOR - HUMAN SERVICES/MANAGEMENT
University of Phoenix
Phoenix, AZ01.2013
ASSOCIATE - HEALTHCARE ADMINISTRATION
University of Phoenix
Phoenix, AZ01.2010
Skills
- Clinical Research
- Project Management
- Regulatory Compliance
- Data Management
- EDC Systems
- Query Resolution
- Site Management
- Quality Control
- Medical Device Knowledge
- ETMF
- Documentation Management
- Documentation And Reporting
Laboratoryexperience
Pharmacokinetics
Therapeuticexperience
- Dermatology: Dermatitis, Atopic
- Device: Body Contouring Device, Degenerative Disk Disease (DDD) Device, Implantable Device, Joint Replacement Device, Orthopedic Other Device
- Immunology / Inflammatory: Allergy, Food, Peanut
- Neurology: Alzheimer's Disease, Multiple Sclerosis, Psychosis, Parkinson's Associated
- Oncology: Cancer, Cancer (Bladder), Cancer (Metastatic Solid Tumors), Cancer (Prostate)
- Respiratory: Cough
Therapeutic Areas
Dermatology- Dermatitis, Atopic
Device- Body Contouring Device
Degenerative Disk Disease (DDD) Device
Implantable Device
Joint Replacement Device
Orthopedic Other Device
Immunology / Inflammatory
Allergy, Food, Peanut Neurology
Alzheimer's Disease
Multiple Sclerosis Psychosis
Parkinson's Associated
Oncology- Cancer
Cancer, Bladder
Cancer, Metastatic Solid Tumors
Cancer, Prostate Respiratory
Pharmacokinetics
Timeline
Sr. Project Specialist
Syneos Health
03.2022 - Current
Clinical Research Coordinator
Columbus Memory Center
03.2021 - 01.2022
Sr. Clinical Research Coordinator
Bay Pines Foundation/Bay Pines VA Medical Center
12.2019 - 02.2021
Sr Clinical Research Corrdinator
Florida Pediatric Associates/Center for Cough
08.2018 - 12.2019
Lead Clinical Research Coordinator
Coastal Orthopedics
05.2016 - 08.2018
Clinical Research Coordinator
National Institute of Health
06.2014 - 04.2016
BACHELOR - HUMAN SERVICES/MANAGEMENT
University of Phoenix
ASSOCIATE - HEALTHCARE ADMINISTRATION
University of Phoenix
Similar Profiles
Natalia AballayNatalia Aballay
Senior Lead Project Specialist – Global Clinical Trials & RWLP at Syneos HealthSenior Lead Project Specialist – Global Clinical Trials & RWLP at Syneos Health
Ashley CosbyAshley Cosby
Pharmaceutical Sales Specialist at Syneos HealthPharmaceutical Sales Specialist at Syneos Health
Aakriti SinghAakriti Singh
Sr. Safety & PV Specialist at Syneos HealthSr. Safety & PV Specialist at Syneos Health
Marshonda WootenMarshonda Wooten
Engagement Center Specialist at Syneos HealthEngagement Center Specialist at Syneos Health
Kimberlee PetersonKimberlee Peterson
Leasing Consultant at RangeWaterLeasing Consultant at RangeWater