Dennis Jenkins, MPH
Clinical Projects Specialist at Alfred Mann Foundation- Claim this Profile
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Bio
Credentials
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SOCRA
Society of Clinical Research Associates (SOCRA)Nov, 2021- Nov, 2024 -
Associate Human Factors Professional (AEP)
AAMIJul, 2021- Nov, 2024
Experience
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huMannity Medtec
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Clinical Projects Specialist
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Aug 2019 - Present
-Participate in all aspects of clinical study start up activities. -Develop study budgets and protocols for review and submission. -Maintain track of deliverables and study milestones for new and ongoing studies. -Train new clinical staff and outside study collaborators. -Develop good relationships with external CRO's and consultants. -Create forecasts for study enrollment and completion dates. -Analyze track-able data for risk calculations to mitigate study delays. -Oversee data management using electronic data capture systems. -Review and supply response to study queries. -Discuss Adverse Events with study Investigators and technical teams. -Create interactive dashboards with study data for reporting and team discussions. -Author study reports. -Maintain clinical documentation on quality management systems (QMS). -Address internal audit queries from QA and develop action plans to correct findings. -Implement Human Factors training into new device design processes. -Cross-collaborate on multiple projects with various stakeholder groups and upper management.
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Doheny Eye Institute
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United States
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Non-profit Organizations
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100 - 200 Employee
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Manager - Disease Evaluation
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2014 - 2019
-Supervisor to a large research team of >20 personnel. -Oversee study operations of multiple phase I-IV clinical trials. -Develop study protocols and data collections methods. -Organize cross-functional team collaborations to discuss project endpoints and deadlines. -Plan and forecast critical timelines for study completion. -Manage queries and responses to quality department for study audits. -Manage data management processes for data integrity. -Provide expertise in the development of custom electronic data capture (EDC) system. -Review software validation reports. -Provide expertise for Software Development Life Cycle (SDLC) processes. -Maintain all duties are within the guidelines of Title 21 CFR Part 11 Compliance, ICH regulatory guidelines, Good Clinical Practices (GCP), General Data Protection Regulation (GDPR), and organizational compliance.
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University of Southern California
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United States
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Higher Education
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700 & Above Employee
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Research Analyst
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2012 - 2014
-Member of the Advanced Imaging for Glaucoma Study (AIGS).-Data management for a multi-site phase II clinical trial. -Manage collection of large data exports from medical devices.-Perform data entry to EDC systems. -Use data analysis software (R) to generate data reports. -Maintain datasets for summary presentation with Principal Investigators using SPSS software. -Present reports on study status, interim data analysis, and Adverse Events with study team.
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Research Intern
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2011 - 2012
This study aimed to learn more about the general eye health in the Chinese-American adult population from patients enrolled in the Chinese-American Eye Study at USC utilizing Optical Coherence Tomography (OCT) images under the supervision of investigator Dr. Dandan Wang. Responsibilities: -Exporting raw image files onto database system.-Perform data cleaning provide summary report to study Investigator.-Analyze study data and provide reports for weekly Investigator meetings.-Travel to clinics for site visits and ensure equipment used was functioning properly.
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Education
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University of Southern California
Master of Public Health - MPH, Biostatistics & Epidemiology -
University of California, Riverside
Bachelor of Arts (B.A.)
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