Clinical Research Associate 3 at V R Della Infotech Inc California
V R Della Infotech Inc, California, MO, United States
Overview
Senior Clinical Research Associate (In-House in Sunnyvale & Field Role). Onsite: Onsite 3 Days Per Week.
Clinical Research Associate 3 role at V R Della Infotech Inc., California.
Essential Job Duties
Contribute to all clinical research activities to ensure the successful start-up and management of clinical studies through FDA approval.
Maintain and track clinical study data, monitor, and assist in Investigator and Sub-Investigator qualification and selection, training, screening of potential patient recruitment, and overall study status and progress throughout the life of a study.
Co-management of site start-up/activation process, including preparation of study-related documents and checklists; assist with clinical trial agreements and budget negotiation; finalize the clinical monitoring plan and training materials.
Assist with eCRFs/EDC system, CTMS, eTMF and imaging Core Labs.
Assist with review of IRB submissions, consents and applicable regulatory documentation with follow-through to ensure successful outcomes.
Assist with amendments to clinical study documents (ICF, CRFs, protocols, Monitoring Plan, study tools, etc.) as needed and assist clinical sites with institutional review board submissions if necessary.
Experience with on-site and/or remote site qualification visits, site initiation visits, interim co-monitoring visits, and site close-out visits with or without the CRO.
Conduct clinical study co-monitoring to ensure regulatory and protocol compliance and data accuracy in accordance with the monitoring plan.
Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on case report forms at sites to ensure regulatory and protocol compliance and data accuracy.
Assist and support participating clinical trial sites to ensure timely data entry, data integrity, query resolution, investigational drug accountability, and study conduct oversight.
Partner with data management (CRO) to assist with data cleaning processes.
Assist with the development and management of study eTMF and maintain study documentation and clinical trial management system (e.g., correspondence, CRFs, approval documents), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget).
Assist the Sr Clinical Project Manager on study scoping activities, including development of pre-study questionnaires, study design, and surgeon/site selection.
Assist Investigational sites with site audits preparation in anticipation of site inspections and during actual audits.
Assist with internal and external audits preparation and during actual audits.
Assist with SIV preparation and presentations.
Assist with Investigators meetings preparation and presentations, including logistics and planning.
Qualifications
Previous experience implementing pharmaceutical trials. Significant knowledge of clinical and/or outcomes research study design. Experience with surgical trials is preferred.
Possess advanced knowledge of clinical investigation of investigational drugs for human subjects.
Knowledge of Good Clinical Practice (ICH/GCP) and other applicable regulations; fundamental knowledge of clinical research and monitoring requirements.
Clinical research/clinical trial management certification or education preferred.
Excellent ability to interact with physicians and other professionals inside and outside the company.
Excellent communication skills.
Experience with protocol and ICF development, and related amendments.
Experience negotiating clinical research contracts and budgets.
Must be able to work effectively cross-functionally.
Must be able to travel up to 40%.
Must be able to manage multiple priorities and maintain high attention to detail and organization.
Ability to learn quickly, adjust to shifting requirements, and self-educate on topics applicable to clinical projects (self-starter attitude).
Proficiency in Microsoft Office Suite and PDF applications.
Experience working with electronic data capture (EDC) systems and clinical trial management systems.
Previous experience implementing, helping and managing drug trials.
Knowledge of statistics, statistical methods, and design of experiments is preferred.
Experience working in a hospital environment with nurses and surgeons preferred.
Required Education and Training
Typically requires a minimum of 8 years of related experience with a BA/BS degree; or a minimum of 6 years of experience with a Nursing degree, a Master’s degree, or an MD/PhD with a minimum of 5 years of clinical research experience.
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Senior Clinical Research Associate (In-House in Sunnyvale & Field Role). Onsite: Onsite 3 Days Per Week.
Clinical Research Associate 3 role at V R Della Infotech Inc., California.
Essential Job Duties
Contribute to all clinical research activities to ensure the successful start-up and management of clinical studies through FDA approval.
Maintain and track clinical study data, monitor, and assist in Investigator and Sub-Investigator qualification and selection, training, screening of potential patient recruitment, and overall study status and progress throughout the life of a study.
Co-management of site start-up/activation process, including preparation of study-related documents and checklists; assist with clinical trial agreements and budget negotiation; finalize the clinical monitoring plan and training materials.
Assist with eCRFs/EDC system, CTMS, eTMF and imaging Core Labs.
Assist with review of IRB submissions, consents and applicable regulatory documentation with follow-through to ensure successful outcomes.
Assist with amendments to clinical study documents (ICF, CRFs, protocols, Monitoring Plan, study tools, etc.) as needed and assist clinical sites with institutional review board submissions if necessary.
Experience with on-site and/or remote site qualification visits, site initiation visits, interim co-monitoring visits, and site close-out visits with or without the CRO.
Conduct clinical study co-monitoring to ensure regulatory and protocol compliance and data accuracy in accordance with the monitoring plan.
Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on case report forms at sites to ensure regulatory and protocol compliance and data accuracy.
Assist and support participating clinical trial sites to ensure timely data entry, data integrity, query resolution, investigational drug accountability, and study conduct oversight.
Partner with data management (CRO) to assist with data cleaning processes.
Assist with the development and management of study eTMF and maintain study documentation and clinical trial management system (e.g., correspondence, CRFs, approval documents), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget).
Assist the Sr Clinical Project Manager on study scoping activities, including development of pre-study questionnaires, study design, and surgeon/site selection.
Assist Investigational sites with site audits preparation in anticipation of site inspections and during actual audits.
Assist with internal and external audits preparation and during actual audits.
Assist with SIV preparation and presentations.
Assist with Investigators meetings preparation and presentations, including logistics and planning.
Qualifications
Previous experience implementing pharmaceutical trials. Significant knowledge of clinical and/or outcomes research study design. Experience with surgical trials is preferred.
Possess advanced knowledge of clinical investigation of investigational drugs for human subjects.
Knowledge of Good Clinical Practice (ICH/GCP) and other applicable regulations; fundamental knowledge of clinical research and monitoring requirements.
Clinical research/clinical trial management certification or education preferred.
Excellent ability to interact with physicians and other professionals inside and outside the company.
Excellent communication skills.
Experience with protocol and ICF development, and related amendments.
Experience negotiating clinical research contracts and budgets.
Must be able to work effectively cross-functionally.
Must be able to travel up to 40%.
Must be able to manage multiple priorities and maintain high attention to detail and organization.
Ability to learn quickly, adjust to shifting requirements, and self-educate on topics applicable to clinical projects (self-starter attitude).
Proficiency in Microsoft Office Suite and PDF applications.
Experience working with electronic data capture (EDC) systems and clinical trial management systems.
Previous experience implementing, helping and managing drug trials.
Knowledge of statistics, statistical methods, and design of experiments is preferred.
Experience working in a hospital environment with nurses and surgeons preferred.
Required Education and Training
Typically requires a minimum of 8 years of related experience with a BA/BS degree; or a minimum of 6 years of experience with a Nursing degree, a Master’s degree, or an MD/PhD with a minimum of 5 years of clinical research experience.
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