Pride Health · 1 day ago
Clinical Research Assistant
Pride Health is seeking a Clinical Research Assistant for a manufacturer of Continuous Glucose Monitoring systems in San Diego, CA. The Clinical Research Assistant will plan and execute clinical studies, manage clinical trials, and collaborate with project management to maintain study timelines.
Responsibilities
Partner with Clinical Affairs management to develop and execute clinical studies
Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Company’s SOPs
Execute assigned clinical trials including start up, subject recruitment & scheduling, consenting, screening, subject training, collection of regulatory documents, conducting study visits, performing SMBG testing, ensuring data is entered in a timely manner and all queries are resolved, managing, and reporting adverse events, serious adverse events, and deviations, and providing IRB close-out reports
Responsible for identifying and escalating safety events and major protocol deviations
May assist with assessing trends for safety and protocol deviations and communicating this to study team and study manager. May also propose and implement corrective and preventative actions
Prepare supplies and account for devices required for clinical studies
Set-up IT equipment for studies
Complete testing of electronic data capturing systems
Write and/or review assigned protocols in consultation with Clinical Affairs management and cross-functional partners
Incorporate understanding of study objectives and key data points when planning for each assigned protocol
Develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.)
Communicate effectively and professionally with coworkers, leadership, and study subjects
Collaborate with project management to establish and maintain study timelines
Clearly demonstrate understanding of clinical study management/prioritization
Manage all clinical tasks and deliverables to meet clinical timeline
Assist with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures
Assist with developing clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under supervision
Coordinate preparation of key documents for trial site submission to IRBs
Assists management with departmental audits of clinical studies and procedures
Collaborate effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders
This position assumes and performs other duties as assigned
Complete tasks under minimal supervision
Qualification
Required
Bachelor's degree in a technical discipline, and a minimum of 2-5 years related experience
Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project
Knowledge of GCP (Good Clinical Practice)
Excellent communication (written and verbal) and presentation skills
Strong organizational skills and ability to deal with competing priorities
Strong critical thinking ability with the ability to work independently
Willing to work, hands-on, in an extremely fast paced environment with high attention to details and accuracy
Strong interpersonal communication skills and ability to work effectively on cross-functional & global teams
Preferred
Certification as a clinical research associate or coordinator (e.g., CCRA, CCRC)
Previous experience as a MA or LVN a plus
Monitoring clinical studies experience or experience as a study coordinator is a plus
Clinical Trial Management System (CTMS) experience
Experience in exercising good judgment in measuring risk vs. business needs
Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships
Excellent organizational skills, attention to detail and a Data-driven, decision-making mindset
Experience in continuous glucose monitoring (CGM) is a plus
Benefits
Comprehensive healthcare coverage (medical, dental, and vision plans)
Supplemental coverage (accident insurance, critical illness insurance and hospital indemnity)
A 401(k)-retirement savings
Life & disability insurance
An employee assistance program
Identity theft protection
Legal support
Auto and home insurance
Pet insurance
Employee discounts with some preferred vendors
Company
Pride Health
Pride Health is a staffing and recruiting company that provides account management and staffing solutions.
Funding
Current Stage
Growth StageRecent News
2025-11-06
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