Clinical Research Associate

Associate Clinical Research SpecialistLocation: Irvine, CA (Hybrid, 50% onsite, 50% remote) Duration: 16+ months contract with the possibility of extension/conversionThe main function of a clinical research specialist is to perform study start-up and conduct activities, including ICF review that meet regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities.Education and Experience:Bachelor's Degree or equivalent in related fieldBachelor's Degree or equivalent with 1 year of experience in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance with experience in the healthcare industry or equivalent work experience.0-2 years of experience requiredWhat else we look for (Preferred):Clinical research certification (ACRP or SoCRA, clinical coordinator/ CRA certification)Experience with electronic data captureGood computer skills in the use of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master File)Good written and verbal communication skills and interpersonal relationship skillsGood problem-solving and critical thinking skillsGood knowledge and understanding of the client's policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocolsGood understanding of regulatory submissions, reporting, and auditsAbility to manage confidential information with discretionStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast-paced environmentMust be able to work in a team environment, including immediate supervisor and other team members in the section or groupAbility to build productive internal/external working relationshipsKey Responsibilities:Participating in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit and site initiation visit).Conducting reviews of documentation needed for internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential Clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, the client's internal SOPs, and US and OUS regulations.Investigating discrepancies and participating in the development of processes to minimize possibility of recurrence during study conduct and closeout.Assisting in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas.Why TalentBurst?At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.