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Clinical Research Associate 4/REMOTE (3300)

Company: Stefanini, Inc
Location: San Diego
Posted on: March 20, 2023

Job Description:

Clinical Research Associate 4/REMOTE (3300)- Medical Device/Pharma/Biotech- Raland Compliance Partners Career Portal Home Page Got it! This site uses cookies to provide you with the best experience. By using this site you agree to our use of cookies. Please read our privacy policy for more information. Access Privacy Policy

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    Medical Device/Pharma/Biotech Clinical Research Associate 4/REMOTE (3300) San Diego, -CA Posted: -2/7/2023 Job Description Job ID#: 186 Job Category: Medical Device/Pharma/Biotech Position Type: Contractor Duration: 12 months Shift: 1
    Job Title: Staff (Level 4) Clinical Research Associate Collaborates with various departments on the design documentation testing and implementation of clinical data studies. Develops systems for organizing data to analyze identify and report trends. Analyzes the interrelationships of data and defines logical aspects of data sets. Prepares reports of clinical trial studies for internal validation and cross validation studies. May evaluate and resolve issues regarding contents of reports. Summary: Able to work under minimal supervision to implement and monitor clinical studies at participating study sites according to FDA"s Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and ICH Guidelines. Assists Clinical Affairs management to plan and execute the design and conduct of Client-sponsored (including Sponsor-Investigator studies). Assists with overall study planning and ensuring that all site visits, monitoring, data collection, reports, and ancillary requirements are appropriately assigned and executed to meet company deadlines, quality expectations, and priorities. Learn to act as department representative/clinical project leader on project teams. Works collaboratively with company"s Biometrics, R&D and Regulatory Affairs groups to compile study results, reports and/or tracking various study documentation. Essential Duties and Responsibilities: * Partner with Clinical Affairs management to develop and execute clinical studies. * Communicate progress updates to Clinical Affairs management and the various functional groups (R&D, Biostats, Clinical Operations). * Write/reviews protocols, and study reports in consultation of CRA personnel and/or study manager. * Develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under direct supervision of study lead and/or study manager. * Maintain thorough understanding of clinical regulations and standards (including changing regulations). * Create and implement regular process improvements. * Act as a study and/or site lead for multiple sites/projects simultaneously. * Clearly demonstrate understanding of clinical study management/prioritization. * Conduct site initiation, monitoring, and close-out visits for Sponsor-Investigator and Client-Sponsored studies. * Complete study monitoring visits. * Assist with documenting initial and re-qualification of new clinical sites for Client-Sponsored studies. * Assist with developing monitoring plan and conventions for Sponsor-Investigator and Client-Sponsored studies. * Act as primary contact for Client-Sponsored clinical sites. * Act as lead coordinator or monitor for Sponsor-Investigator studies. * Work on projects and routinely creates, suggests, and/or implements regular process improvements. * Work independently to manage all clinical tasks and deliverables to meet clinical timeline * Provide training to study staff and subjects at clinical sites. * Collaborate effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders. * Responsible for identifying and escalating safety events for Sponsor-Investigator and Client-Sponsored studies. * Responsible for identifying and escalating major protocol deviations for Sponsor-Investigator and Dexcom-Sponsored studies. * May assist with assessing trends for safety and protocol deviations and communicating this to study team and study manager * Maintain organization, preparation and ordering of supplies and equipment required for clinical studies. * Process timely shipping of clinical study supplies and equipment. * Assist with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures. * Set-up IT equipment for Sponsor-Investigator and Client-Sponsored sites. * Complete testing of electronic data capturing systems. * Quality control SME for study-related documents and be accountable for their correct distribution. * Initiate distribution of all regulatory documents and maintain for assigned clinical trials. * Provide support to CRA personnel for preparing documentation, reports, and presentations. * Coordinate study-related meetings, as needed. * Perform scribe function during clinical meetings and produce meeting minutes for management review. * Assists management with departmental audits of clinical studies and procedures. * Coordinate Sponsor-Investigator studies and complete all study-related responsibilities. * Maintain tracking mechanism for regulatory documents for any regulatory submission (FDA or other regulatory body). * Prepare of key documents for trial site submission to IRBs. * Assist in the creation and maintenance of tracking mechanisms for all study-related documents, activities, and projects through all phases of the study. * Draft clinicaltrials.gov submissions. * This position assumes and performs other duties as assigned. * Complete tasks under minimal or no direct supervision. Experience and Education Requirements: * Bachelor"s (BA or BS) degree in a STEM discipline, and at least 8 years of related experience. or Master"s degree in a STEM discipline, and 5 years of related experience. * Current GCP (Good Clinical Practice) Training. * Clinical Trial Management System (CTMS) experience. * Manage multiple, diversified tasks concurrently and to prioritize projects and tasks effectively. * Monitoring clinical studies experience. Preferred Qualifications: * Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS). * Study coordinator experience. Travel Required: * 25-50%. * Local to San Diego, California or willing to relocate OR may work remotely elsewhere, with approval. Functional Description: * Requires specific expertise in an engineering and/or scientific area(s) * Ability to contribute to and propel engineering and/or scientific innovation in support of Company"s technology strategies * Demonstrates successes in technical proficiency, engineering/scientific creativity, and collaboration with others * Recognized internally and externally as a technology leader * Progression through the engineering levels requires increasing expertise in breath and depth of technological areas * In some instances, may require management skill, broad technical and functional expertise, and business knowledge Functional/Business Knowledge: * Possesses advanced knowledge of technical principles and theories. Recommends solutions in support of functional objectives tied to overall company objectives and strategies. Scope: * Demonstrates significant technical expertise, collaboration with others and independent thought. Anticipates potential complex problems requiring an in-depth evaluation. * Demonstrates strategic thinking and commercial/industry understanding in functional projects. * Determines methods and procedures on new assignments and may coordinate activities of other colleagues Supervisory Responsibilities This job has no supervisory responsibilities.
    Language Skills: Ability to read, analyze, and interpret general business correspondence and governmental regulations. Ability to write basic reports, emails, and transcribe notes either orally or handwritten Ability to effectively present information and respond to questions from managers, clients, customers, and the general public. Ability to effectively interact with international customers and their local customs as needed. Writes/reviews protocols, study reports, and other materials. Apply negotiation skills, manage Dexcom-Sponsored partners and critical business assets when needed. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; and stoop, kneel, crouch, or crawl. The employee must be able to lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, and ability to adjust focus.
    Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. The work environment may include collaboration with and/or supervision by remote employees, so excellent communication, independence, self-drive, and discipline skills are required. Job Title: Staff (Level 4) Clinical Research Associate Collaborates with various departments on the design documentation testing and implementation of clinical data studies. Develops systems for organizing data to analyze identify and report trends. Analyzes the interrelationships of data and defines logical aspects of data sets. Prepares reports of clinical trial studies for internal validation and cross validation studies. May evaluate and resolve issues regarding contents of reports. Summary: Able to work under minimal supervision to implement and monitor clinical studies at participating study sites according to FDA"s Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and ICH Guidelines. Assists Clinical Affairs management to plan and execute the design and conduct of Client-sponsored (including Sponsor-Investigator studies). Assists with overall study planning and ensuring that all site visits, monitoring, data collection, reports, and ancillary requirements are appropriately assigned and executed to meet company deadlines, quality expectations, and priorities. Learn to act as department representative/clinical project leader on project teams. Works collaboratively with company"s Biometrics, R&D and Regulatory Affairs groups to compile study results, reports and/or tracking various study documentation. Essential Duties and Responsibilities: * Partner with Clinical Affairs management to develop and execute clinical studies. * Communicate progress updates to Clinical Affairs management and the various functional groups (R&D, Biostats, Clinical Operations). * Write/reviews protocols, and study reports in consultation of CRA personnel and/or study manager. * Develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under direct supervision of study lead and/or study manager. * Maintain thorough understanding of clinical regulations and standards (including changing regulations). * Create and implement regular process improvements. * Act as a study and/or site lead for multiple sites/projects simultaneously. * Clearly demonstrate understanding of clinical study management/prioritization. * Conduct site initiation, monitoring, and close-out visits for Sponsor-Investigator and Client-Sponsored studies. * Complete study monitoring visits. * Assist with documenting initial and re-qualification of new clinical sites for Client-Sponsored studies. * Assist with developing monitoring plan and conventions for Sponsor-Investigator and Client-Sponsored studies. * Act as primary contact for Client-Sponsored clinical sites. * Act as lead coordinator or monitor for Sponsor-Investigator studies. * Work on projects and routinely creates, suggests, and/or implements regular process improvements. * Work independently to manage all clinical tasks and deliverables to meet clinical timeline * Provide training to study staff and subjects at clinical sites. * Collaborate effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders. * Responsible for identifying and escalating safety events for Sponsor-Investigator and Client-Sponsored studies. * Responsible for identifying and escalating major protocol deviations for Sponsor-Investigator and Dexcom-Sponsored studies. * May assist with assessing trends for safety and protocol deviations and communicating this to study team and study manager * Maintain organization, preparation and ordering of supplies and equipment required for clinical studies. * Process timely shipping of clinical study supplies and equipment. * Assist with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures. * Set-up IT equipment for Sponsor-Investigator and Client-Sponsored sites. * Complete testing of electronic data capturing systems. * Quality control SME for study-related documents and be accountable for their correct distribution. * Initiate distribution of all regulatory documents and maintain for assigned clinical trials. * Provide support to CRA personnel for preparing documentation, reports, and presentations. * Coordinate study-related meetings, as needed. * Perform scribe function during clinical meetings and produce meeting minutes for management review. * Assists management with departmental audits of clinical studies and procedures. * Coordinate Sponsor-Investigator studies and complete all study-related responsibilities. * Maintain tracking mechanism for regulatory documents for any regulatory submission (FDA or other regulatory body). * Prepare of key documents for trial site submission to IRBs. * Assist in the creation and maintenance of tracking mechanisms for all study-related documents, activities, and projects through all phases of the study. * Draft clinicaltrials.gov submissions. * This position assumes and performs other duties as assigned. * Complete tasks under minimal or no direct supervision. Experience and Education Requirements: * Bachelor"s (BA or BS) degree in a STEM discipline, and at least 8 years of related experience. or Master"s degree in a STEM discipline, and 5 years of related experience. * Current GCP (Good Clinical Practice) Training. * Clinical Trial Management System (CTMS) experience. * Manage multiple, diversified tasks concurrently and to prioritize projects and tasks effectively. * Monitoring clinical studies experience. Preferred Qualifications: * Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS). * Study coordinator experience. Travel Required: * 25-50%. * Local to San Diego, California or willing to relocate OR may work remotely elsewhere, with approval. Functional Description: * Requires specific expertise in an engineering and/or scientific area(s) * Ability to contribute to and propel engineering and/or scientific innovation in support of Company"s technology strategies * Demonstrates successes in technical proficiency, engineering/scientific creativity, and collaboration with others * Recognized internally and externally as a technology leader * Progression through the engineering levels requires increasing expertise in breath and depth of technological areas * In some instances, may require management skill, broad technical and functional expertise, and business knowledge Functional/Business Knowledge: * Possesses advanced knowledge of technical principles and theories. Recommends solutions in support of functional objectives tied to overall company objectives and strategies. Scope: * Demonstrates significant technical expertise, collaboration with others and independent thought. Anticipates potential complex problems requiring an in-depth evaluation. * Demonstrates strategic thinking and commercial/industry understanding in functional projects. * Determines methods and procedures on new assignments and may coordinate activities of other colleagues Supervisory Responsibilities This job has no supervisory responsibilities. Language Skills: Ability to read, analyze, and interpret general business correspondence and governmental regulations. Ability to write basic reports, emails, and transcribe notes either orally or handwritten Ability to effectively present information and respond to questions from managers, clients, customers, and the general public. Ability to effectively interact with international customers and their local customs as needed. Writes/reviews protocols, study reports, and other materials. Apply negotiation skills, manage Dexcom-Sponsored partners and critical business assets when needed. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; and stoop, kneel, crouch, or crawl. The employee must be able to lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, and ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. The work environment may include collaboration with and/or supervision by remote employees, so excellent communication, independence, self-drive, and discipline skills are required. Job Requirements
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Keywords: Stefanini, Inc, San Diego , Clinical Research Associate 4/REMOTE (3300), Healthcare , San Diego, California

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