Kel Nwuke
Houston,Texas
Summary
Analytical, organized and detail-oriented Clinical Research professional with 6 years of experience in the clinical research industry. Collaborative team-player with an ownership mentality and a record of delivering the highest quality in-depth knowledge on clinical operations, clinical monitoring, and study coordination to resolve challenges and propel business growth.
Overview
6
6
years of professional experience
Work History
SENIOR CLINICAL RESEARCH ASSOCIATE
TRANSFORMATIVE PHARMACEUTICAL SOLUTIONS
02.2022 - Current
- Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes
- Verifies protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations
- Ensures integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs
- Writes and submits reports of investigational site findings and updates applicable tracking systems
- Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.
- Participates in audit preparation and follow-up activities as needed
- Serves as preceptor, providing training to less experienced clinical team members
- Assist with managing defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines
- Demonstrate experience in working on multiple priorities consecutively and sequentially and meeting quality standards for accuracy, attention to detail and timelines
- Assist in the creation, maintenance, and ongoing quality review of the trial master file (eTMF) to ensure files are properly maintained and up to date, archived and stored under direction of the Associate Director of Clinical Operations
- Assist with planning investigator meetings and preparing site training materials
- Tracks action items to ensure timely resolution
- Assist with training internal and external CRAs, CRO team members, and investigative site staff
- Participate in the preparation of study-specific documentation (e.g., study reference manuals)
- Provide logistical support for the study team, scheduling meetings, distributing agendas, and writing minutes
- Track key study activities using tracking tools
- Maintain eTMF on a regular basis
- Ensure that supportive study supplies, and documents are available (e.g., clinical supplies, IP kits, non-clinical supply materials)
- Other projects and duties when assigned
CLINICAL RESEARCH MANAGER
TFS HEALTH SCIENCE
06.2021 - 02.2022
- Responsible for overseeing all aspects of monitoring and site management activities ensuring compliance with ICH/GCP guidelines, SOP and protocol requirements
- Lead, manage and guide CRAs being responsible for training and quality oversight of site management activated while proactively identifying potential operational issues and ensuring study deliverables
- Development of study monitoring plans monitor and site training plans, verification initiatives, coordinating Study investigator meetings and reviewing site and country study reports
- Ensure study processes, procedure and expectations correspond to the practicality of conducting the trial from study feasibility through to close out
- Serve as initial point of contact for the monitoring team and support them with investigative site personnel liaison
- Perform co-monitoring visits as part of the monitoring team quality oversight
- Review and approve site visit reports (PSV, SIV, MV and COV) with agreed and act as first point of contact for issue escalation ensuring the proper resolution and action plan definition and follow up
- Review CRA Site Visits calendar ensuring monitoring visits (both remotely and on site) are being scheduled and conducted following monitoring plan frequency.
- Update the Project Manager with status of sites and countries and ensure a proper escalation of any issue detected at site/country level
- Assist Project Manager in CRA training program, training CRAs on study procedures and requirements and ensuring a proper handover when there is a replacement of CRA
- Review CTMS to ensure country, site and subject information is recorded properly and on a regular basis
- Interact with CRAs Line Managers (in case they are not) to ensure the proper CRA study allocation and discuss performance issues if any to ensure a proper follow up and resolution plan
- Success Examples:
- Due to excellent customer service sponsor expectations, study team was awarded Open Label extension study within 3 months of potentially losing the client due to previous quality issues before tenure as Clinical Research Manager
- Served as a floating Clinical Research Manger to serve difficult projects.
SENIOR CLINICAL RESEARCH ASSOCIATE
TFS HEALTH
12.2020 - 06.2021
- SCIENCE
- Conducted PSSV, SIV, IMV and COV for assigned sites
- Interfaced with sponsor representatives and study team to ensure timely initiation and completion of clinical trials
- Collected and reviewed regulatory documents received from clinical sites to ensure all required documents are obtained, completed and in compliance with ICH-GCP and local regulations
- Assisted with preparation, review, and submission of all relevant regulatory documents to the appropriate Regulatory Authorities and IRB/IECs
- Maintained and updated project-related data in an existing database
- Success Examples:
- Due to excellent metrics and quality that exceeded various sponsor expectations, a promotion to
- Clinical Research Manager was given
- In first week as CRM, successfully lead the completion of study plans and moved the anticipated timeline for a study one quarter ahead
- Promoted to
- Clinical Research Manager after a six-month tenure.
SENIOR CLINICAL RESEARCH ASSOCIATE
COVANCE
05.2019 - 12.2020
- Maintain the project tracking system of subjects and site information
- Obtain, review and process essential regulatory and administrative documents
- Report and write narratives and follow-up on serious adverse experiences
- Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance
- Ensure the integrity of data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
- Serve as lead monitor for protocols or projects and assisting in establishing monitoring plans as assigned
- Assist SSU team in participating in feasibility research.
CLINICAL RESEARCH ASSOCIATE I
COVANCE
07.2017 - 05.2019
- Conducted PSSV, SIV, IMV and COV for assigned sites
- Performed monitoring and tracking study progress, thereby contributing to the overall management of clinical trials in accordance with the standards ICH-GCP and applicable local regulations and Standard Operating Procedures (SOPs)
- Managed clinical study start-up, maintenance and closure activities including maintenance of study documents
- Assisted with preparation, review, and submission of all relevant regulatory documents to
- Participated in required training and education programs
- Maintained Trial Master File (TMF) and/or Investigator site files for the duration of the study, ensuring essential documents are filed appropriately, and assisted in the file review and reconciliation process in preparation for audits and archival.
Education
MASTER OF BUSINESS ADMINISTRATION, LEADERSHIP - DATA ANAYTICS
UNIVERSITY OF HOUSTON - DOWNTOWN
08.2023
BACHELOR OF SCIENCE - BIOSCIENCES AND BIOTECHNOLOGY, MICROBIOLOGY
BABCOCK UNIVERSITY
06.2017
Skills
- THERAPEUTIC EXPERIENCE
- NEUROLOGY: Parkinson’s Disease, Multiple Sclerosis, Bipolar Disorder, Duchenne Muscular
- Dystrophy
- INFECTIOUS DISEASES: Influenza Virus, Chikungunya Virus, COVID-19
- ONCOLOGY: Pancreatic Cancer, Multiple Myeloma, Breast Cancer, NSCLC
- CARDIOVASCULAR: Hypertension, Atrial Fibrillation
- Meeting Reporting
- Reviewing Data Standards
Timeline
SENIOR CLINICAL RESEARCH ASSOCIATE
TRANSFORMATIVE PHARMACEUTICAL SOLUTIONS
02.2022 - Current
CLINICAL RESEARCH MANAGER
TFS HEALTH SCIENCE
06.2021 - 02.2022
SENIOR CLINICAL RESEARCH ASSOCIATE
TFS HEALTH
12.2020 - 06.2021
SENIOR CLINICAL RESEARCH ASSOCIATE
COVANCE
05.2019 - 12.2020
CLINICAL RESEARCH ASSOCIATE I
COVANCE
07.2017 - 05.2019
MASTER OF BUSINESS ADMINISTRATION, LEADERSHIP - DATA ANAYTICS
UNIVERSITY OF HOUSTON - DOWNTOWN
BACHELOR OF SCIENCE - BIOSCIENCES AND BIOTECHNOLOGY, MICROBIOLOGY
BABCOCK UNIVERSITY
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