Intellectt Inc
Clinical Research Associate
Intellectt Inc, Alameda, California, United States, 94501
This is Tanmai from Intellect Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to tanmai@intellectt.com or call me at +1(732) 696-7434.Role: Clinical Research Associate (CRA) - B
Location:
Alameda, CA - 94502Duration:
6 Months on W2Shift Timings:
8:00am to 5:00pmJob Description
Assist in managing assigned clinical studies from concept to clinical study report.Conduct single or multi-center medical device clinical studies.Perform site visits, generate monitoring reports, and track action items.Participate in study start-up activities.Manage clinical monitoring and site activities, ensuring compliance with protocols and regulations.Assist senior staff in planning study conduct, designing forms, managing CROs, investigator sites, etc.Maintain Trial Master File for inspection readiness.Review clinical data listings, escalate issues as needed.Collaborate in cross-functional clinical teams.Ensure quality study delivery within budgets and timelines.Participate in data reviews for regulatory submissions.Assist in preparing study documents (TMF, Protocols, Reports).May interact with RA/QA for audits and inquiries.Education And Experience
BS degree with 5+ years, MS with 3+ years, or PhD with 2+ years of related experience.5+ years of relevant experience in site monitoring, clinical project management, and trial practices.Experience in medical device and/or in-vitro diagnostics studies; pharmaceutical background considered.Skills Desired
Understanding of clinical trial process, data management, analysis, and reporting.Adaptability to manage multiple projects and changing priorities.Knowledge of GCP, Clinical and Regulatory Affairs.Proficiency in Microsoft Suite.Travel Requirements
Expected travel of 30-50%.
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Location:
Alameda, CA - 94502Duration:
6 Months on W2Shift Timings:
8:00am to 5:00pmJob Description
Assist in managing assigned clinical studies from concept to clinical study report.Conduct single or multi-center medical device clinical studies.Perform site visits, generate monitoring reports, and track action items.Participate in study start-up activities.Manage clinical monitoring and site activities, ensuring compliance with protocols and regulations.Assist senior staff in planning study conduct, designing forms, managing CROs, investigator sites, etc.Maintain Trial Master File for inspection readiness.Review clinical data listings, escalate issues as needed.Collaborate in cross-functional clinical teams.Ensure quality study delivery within budgets and timelines.Participate in data reviews for regulatory submissions.Assist in preparing study documents (TMF, Protocols, Reports).May interact with RA/QA for audits and inquiries.Education And Experience
BS degree with 5+ years, MS with 3+ years, or PhD with 2+ years of related experience.5+ years of relevant experience in site monitoring, clinical project management, and trial practices.Experience in medical device and/or in-vitro diagnostics studies; pharmaceutical background considered.Skills Desired
Understanding of clinical trial process, data management, analysis, and reporting.Adaptability to manage multiple projects and changing priorities.Knowledge of GCP, Clinical and Regulatory Affairs.Proficiency in Microsoft Suite.Travel Requirements
Expected travel of 30-50%.
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