MORGAN KENNETH
Bear,DE
Summary
Accomplished Clinical Research Associate with a robust background in managing and overseeing clinical trials across various therapeutic areas. Possess a deep understanding of clinical trial processes, ICH GCPs, and FDA regulations. Skilled in clinical site activation, study start-up processes, and proficient in IRB guidelines. Demonstrates a thorough grasp of clinical monitoring techniques, data management, and site management including Pre-Study, Routine, and Closeout visits. Committed to ethical research practices and upholding HIPAA standards, with extensive experience in multi-therapeutic clinical trials. Adept in fostering collaborative relationships, possessing excellent communication skills, and consistently meeting tight deadlines under pressure. Brings a track record of training and guiding teams in complex clinical environments, leveraging strong knowledge in various EDC, CTMS, and ETMF systems, underpinning a career characterized by dedication, versatility, and exceptional proficiency in the clinical research field.
Overview
14
14
years of professional experience
Work History
Clinical Research Associate
Natera Pharma.
09.2021 - Current
- Conducted routine site visits, including Pre-Study, Initiation, Routine, and Closeout, ensuring adherence to informed consent procedures, protocol compliance, GCP/ICH Guidelines, and regulatory requirements, while promoting excellent site performance
- Managed assigned sites effectively by establishing regular communication channels, ensuring site compliance, fostering adequate enrollment, and clarifying study requirements
- Successfully obtained, reviewed for appropriateness, and processed regulatory and administrative documents from investigator sites
- Performed thorough source document reviews and source document verifications
- Collaborated closely with the Data Management Team (DMT) to resolve queries of CRF data with study personnel
- Conducted detailed reviews of Tables and Listings generated from study data
- Maintained efficient project-tracking systems for monitoring subject and site information
- Actively participated in company-required training programs, enhancing professional development
- Executed necessary remote and administrative tasks, including site payment reconciliation, and timely submission of trip reports, expense reports, and timesheets
- Developed and implemented targeted action plans for sites, such as Recruitment and Data matrix strategies
- Fostered and maintained strong relationships with sites and investigators to ensure efficient management of Clinical trials
- Performed co-monitoring visits and provided trainings to CRAs, enhancing team skills and knowledge.
Clinical Research Associate I
GE Clinical Research.
01.2017 - 08.2021
- Successfully oversaw all facets of study site monitoring, including conducting pre-study site visits, site initiation, routine monitoring, and close-out visits at various clinical sites
- Effectively managed and trained site personnel on therapeutic areas, protocol requirements, and proper source documentation, enhancing site performance and compliance
- Vigilantly ensured the protection of study subjects by meticulously verifying adherence to informed consent procedures and protocol requirements in line with ICH/GCP regulations
- Diligently monitored, tracked, and followed up on all Adverse Events (AEs) and Serious Adverse Events (SAEs), ensuring prompt and accurate reporting
- Guaranteed the accuracy and integrity of data in electronic or paper Case Report Forms (CRFs) through comprehensive source document reviews
- Proactively reviewed data queries and listings, collaborating closely with the study team to resolve data discrepancies
- Performed thorough Investigational Product (IP) accountability, ensuring IPs were dispensed, used, and returned following the protocol
- Ensured all monitoring tasks were conducted in strict adherence to SOPs, established guidelines, and monitoring plans
- Developed and utilized spreadsheets and other tracking tools for efficiently managing deadlines and monitoring regulatory document expiry dates
- Monitored and meticulously documented laboratory sample storage and shipment processes
- Executed essential remote and administrative tasks, including site payment reconciliation, and the timely submission of trip reports, expense reports, and timesheets
- Reviewed data queries, assisted sites with query resolution and followed up on outstanding queries.
Clinical Study Coordinator
Alchemi Research Center
01.2014 - 01.2017
- Compounded and dispensed prescribed IP
- Supervised and maintained records of all medications
- Ensured compliance with study-specific blinding plans
- Provided consultative support regarding the preparation and dosing of drugs
- Maintained documentation of IP accountability, receipt, dispensing, return to sponsor/destruction
- Interpreted clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials
- Understood and applied all applicable site procedures
- Ensured receipt and proper storage of IP and bioretention samples
- Managed inventory, ensuring that expired items are removed from the inventory prior to expiration, and purchasing, and delivery processes for the pharmacy
- Reviewed protocols and provided input on clinical and pharmacy supply needs
- Met with sponsors, monitors, auditors, and regulatory authorities to review drug accountability and other study-specific information
- Temperature reporting
- Performed any other duties/tasks assigned by the manager, computer proficiency, especially Word, Excel, Outlook, and Google Docs.
Clinical Quality Analyst-HEDIS Over-reader/Abstractor
UGH
01.2013 - 05.2015
- Exhibited prior knowledge by efficiently researching medical records for proper medical terminology
- Volunteered in milestone projects to meet the needs of the organization
- Maintained accurate medical review and abstractions as required
- Maintained a high level of confidentiality in compliance with HIPPA regulations
- Conducted comprehensive reviews of HEDIS data, including medical records, claims, and other relevant documentation
- Verified accuracy and completeness of HEDIS data elements, ensuring compliance with quality measures and regulations
- Identified discrepancies, coding errors, and documentation gaps; and provided recommendations for improvement
- Collaborated with healthcare providers and medical staff to address data quality issues and facilitate corrective actions
- Tracked and documented findings, trends, and opportunities for process enhancement
- Conducted regular training sessions for HEDIS Abstractors and provided guidance on data collection and validation best practices
- Performed Overreads and Medical Record Review Validations for CIS, IMA, EED, PPC, TRC, LSC, HBD, BPD, COA, WCC, and CCS measures.
Clinical Trial Assistant
Alchemi Research Center
04.2011 - 01.2014
- Interpreted protocol(s) correctly and completely, to ensure consistent compliance with applicable standards and related requirements
- Reviewed medical records against inclusion/exclusion criteria to identify potential subjects
- Assisted in the education of patients and healthcare professionals on the study protocol to ensure complete and correct understanding of information
- Maintained and prepared lab kits for subject visits
- Assisted coordinators with subject visit and Investigator Team
- Maintained clinical source records
- Organized Investigator Site Files
- Assisted Sponsor and Monitor Visits
- Performed job duties and assigned tasks in a safe, efficient, and effective manner, as well as in a manner that is compliant with all company policies, procedures, protocols, and practices
- Performed other duties assigned as it relates to the site needs.
Clinical Quality Analyst-HEDIS Researcher
Elevance Health
01.2011 - 05.2013
- Conducted data analysis within data/claims systems and performed thoughtful and methodical research to locate specific claim/provider information
- Contacted Providers as needed to follow up on requested medical records and maintain excellent research and contact documentation
- Participated in special projects in work groups and partnerships
- Collaborated with management to analyze HEDIS results and identify opportunities for improvement
- Researched medical records that were assigned for appropriate measure compliance
- Utilized HEDIS guidelines and other resources approved by National Committee of Quality Assurance (NCQA)
- Supported the HEDIS data collection process by coordinating medical record retrieval, abstraction, and data submission
- Conducted regular audits of medical records to ensure compliance with HEDIS measures and regulatory requirements
- Collaborated with management to analyze HEDIS results and identify opportunities for improvement
- Completed all required measure training and assessments.
Skills
- Clinical Trials Expertise: Extensive experience in conducting and overseeing clinical trials, ensuring adherence to protocols and regulatory standards
- ICH GCP Knowledge: Profound understanding of International Council for Harmonization - Good Clinical Practice guidelines, ensuring trials are conducted ethically and effectively
- Site Management and Monitoring: Skilled in managing multiple clinical sites, ensuring compliance, and maintaining high standards of clinical monitoring
- Communication Skills: Exceptional ability to communicate effectively with diverse teams, enhancing collaboration and ensuring a clear understanding of trial processes
Therapeutic Experience
- Medical Device: IVD (rapid test). Cardiac Pacemaker.
- Oncology: Lung Cancer | Breast Cancer.
- Cardiovascular: Myocardial Infarction | Stroke | Hypertension.
- Neurology: Parkinson Disease | Bi-Polar Disorder | Schizophrenia | Depression.
- Vaccine: Influenza | Covid-19.
- Respiratory: Pneumonia | Asthma | Chronic COPD
- Dermatology: Severe burns | Hand Eczema | Adult Acne.
Areas of Expertise
- FDA Regulations
- Site Activation
- Study Start-up
- IRB Processes
- Ethical Research
- HIPAA Compliance
- Deadline-Oriented
- Collaboration
- Microsoft Office Proficiency
Education
Bachelors Of Science - Psychology
UNIVERSITY OF IBADAN
PROFICIENCY
- Microsoft Office Proficiency
- CTMS: Veeva Site Vault | IMPACT | BioClinical
- EDC: Trial Master | Medidata | Rave | Zelta
- IWRS: Calyx | Signant Health | Suvoda
- EMR Systems: EPIC | Sorian | Cerner | | RATEMAX | CIOX | ADVANTMED.
- SPLUNK | AWS | LINUX
Timeline
Clinical Research Associate
Natera Pharma.
09.2021 - Current
Clinical Research Associate I
GE Clinical Research.
01.2017 - 08.2021
Clinical Study Coordinator
Alchemi Research Center
01.2014 - 01.2017
Clinical Quality Analyst-HEDIS Over-reader/Abstractor
UGH
01.2013 - 05.2015
Clinical Trial Assistant
Alchemi Research Center
04.2011 - 01.2014
Clinical Quality Analyst-HEDIS Researcher
Elevance Health
01.2011 - 05.2013
Bachelors Of Science - Psychology
UNIVERSITY OF IBADAN
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