Intellectt Inc

Clinical Research Associate. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.. Experience with study start up, monitoring, and close out activities. Support or lead clinical research study start up activities (includes creation of study binders, study logs, work instructions, case report form, and other study related materials). Ability to train site personnel on study activities including investigational product usage, maintenance and accountability, sample collection, testing and shipping, data entry and query resolution.

clinical research associate

𝐑𝐨𝐥𝐞: Clinical Research Associate 𝐋𝐨𝐜𝐚𝐭𝐢𝐨𝐧: San Diego, CA Duration: 05 Months 100% onsite Job Description Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary. 3-5 Years Experience Level. Top 3 Skills You’re Looking For On Resume <ul><li>Education: Bachelors Degree or Higher</li><li>On-site and monitoring experience 2-5 years.</li><li>Experience with study start up, monitoring, and close out activities</li><li>Ability to work independently, get training done and able to hit the ground quickly.</li><li>Apply knowledge of FDA regulations to site monitoring and clinical study design duties.</li><li>Monitor and maintain necessary supplies, with approval by senior department staff.</li><li>Maintain effective, professional, timely, and consistent communications with clinical sites both in person, and via all available correspondence media (telephone, email, web, etc.)</li><li>Support or lead clinical research study start up activities (includes creation of study binders, study logs, work instructions, case report form, and other study related materials)</li><li>Ability to train site personnel on study activities including investigational product usage, maintenance and accountability, sample collection, testing and shipping, data entry and query resolution.</li><li>Study monitoring (includes assessing the familiarity of the site personnel with the protocol, procedures, and investigational product, assessing protocol compliance and investigational product accountability as applicable, source document verification, identifying protocol deviations, writing queries, writing monitoring reports, notes to file, and other documentation as necessary)</li></ul>

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