Clinical Research Specialist

Clinical Research SpecialistDuration - 16 Months, Contract, W-2Location - Irvine, CAPay - $38 - $43.55 an hrHow you will make an impact:Participating in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and competent authority audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, 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.What you'll need (Required):Bachelor'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 based on company criteria.What else we look for (Preferred):Clinical research certification (ACRP or SoCRA, clinical coordinator/ CRA certification)Experience with electronic data captureGood computer skills in usage 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 company 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 relationshipsEducation and Experience:Bachelor's Degree or equivalent in related field0-2 years of experience requiredAll qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.Job Reference: JN -082026-428313