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Job Description
Job Summary:
The Senior Clinical Research Associate (Sr. CRA) is responsible for providing comprehensive monitoring and site management support across multiple clinical trial sites. This position ensures high ? quality execution of clinical studies, adherence to protocols, compliance with GCP and all applicable regulations, and supports the operational needs of the broader clinical team. The Sr. CRA builds strong site relationships, supports enrollment and data quality, collects essential study documentation, and plays an active role in ensuring audit readiness. Essential Functions /
Job Responsibilities:
Monitoring & Site Management Conduct qualification, initiation, interim, and close ? out monitoring visits; develop and review monitoring visit reports. Act as a primary contact and resource for study site staff; perform study ? related training for investigators and site coordinators. Ensure investigational sites follow study protocols, GCP, and regulatory requirements; identify site ? level risks and escalate appropriately. Support subject enrollment, data accuracy, subject retention, and provide ongoing site status updates. Ensure sites maintain IRB/EC approvals and required submissions, including progress reports. Study Start ? Up & Document Management Support study start ? up activities including IRB/EC submissions and management of essential documents. Contribute to creation and maintenance of essential study documents such as protocols, informed consents, study plans, and site ? facing resources. Develop study tools such as manuals of operations, source worksheets, and training materials. Maintain the electronic Trial Master File (eTMF) and Investigator Site Files (ISF), including inspection readiness checks. Data Quality & EDC Support Ensure timely entry of eCRF data by investigational sites; monitor data trends and support query resolution. Support EDC development tasks such as user acceptance testing and ongoing maintenance. Operational & Cross Functional Support Assist with investigational product management, including shipping, returns, and accountability. Support vendor qualification, oversight, and evaluation. Participate in or lead project meetings; prepare and distribute meeting minutes and site ? facing communications. Support preparation of clinical study reports and internal/external audit readiness. Process Improvement Proactively assess areas for site or internal process improvement, training needs, and workflow efficiencies. Qualifications Bachelor's degree in a science or healthcare ? related field, or equivalent work experience. Minimum 5+ years of clinical monitoring and site management experience, ideally spanning study start ? up through close ? out without CRO oversight. Experience with Class III medical devices and/or cardiovascular trials preferred. Strong organizational, communication, interpersonal, and problem ? solving skills; ability to manage multiple priorities. Extensive knowledge of ICH, ISO, and FDA regulations. Proficiency with Microsoft Word, Excel, PowerPoint, Smartsheet, and common industry-related computer applications (EMR/EHR, EDC, CTMS, eTMF). Experience with Veeva Vault and Medidata RAVE, a plus Ability to travel up to 50-70% depending on study requirements. Company Join an innovative, rapidly expanding, clinical-stage medical device company and be part of something revolutionary!
Job Summary:
The Senior Clinical Research Associate (Sr. CRA) is responsible for providing comprehensive monitoring and site management support across multiple clinical trial sites. This position ensures high ? quality execution of clinical studies, adherence to protocols, compliance with GCP and all applicable regulations, and supports the operational needs of the broader clinical team. The Sr. CRA builds strong site relationships, supports enrollment and data quality, collects essential study documentation, and plays an active role in ensuring audit readiness. Essential Functions /
Job Responsibilities:
Monitoring & Site Management Conduct qualification, initiation, interim, and close ? out monitoring visits; develop and review monitoring visit reports. Act as a primary contact and resource for study site staff; perform study ? related training for investigators and site coordinators. Ensure investigational sites follow study protocols, GCP, and regulatory requirements; identify site ? level risks and escalate appropriately. Support subject enrollment, data accuracy, subject retention, and provide ongoing site status updates. Ensure sites maintain IRB/EC approvals and required submissions, including progress reports. Study Start ? Up & Document Management Support study start ? up activities including IRB/EC submissions and management of essential documents. Contribute to creation and maintenance of essential study documents such as protocols, informed consents, study plans, and site ? facing resources. Develop study tools such as manuals of operations, source worksheets, and training materials. Maintain the electronic Trial Master File (eTMF) and Investigator Site Files (ISF), including inspection readiness checks. Data Quality & EDC Support Ensure timely entry of eCRF data by investigational sites; monitor data trends and support query resolution. Support EDC development tasks such as user acceptance testing and ongoing maintenance. Operational & Cross Functional Support Assist with investigational product management, including shipping, returns, and accountability. Support vendor qualification, oversight, and evaluation. Participate in or lead project meetings; prepare and distribute meeting minutes and site ? facing communications. Support preparation of clinical study reports and internal/external audit readiness. Process Improvement Proactively assess areas for site or internal process improvement, training needs, and workflow efficiencies. Qualifications Bachelor's degree in a science or healthcare ? related field, or equivalent work experience. Minimum 5+ years of clinical monitoring and site management experience, ideally spanning study start ? up through close ? out without CRO oversight. Experience with Class III medical devices and/or cardiovascular trials preferred. Strong organizational, communication, interpersonal, and problem ? solving skills; ability to manage multiple priorities. Extensive knowledge of ICH, ISO, and FDA regulations. Proficiency with Microsoft Word, Excel, PowerPoint, Smartsheet, and common industry-related computer applications (EMR/EHR, EDC, CTMS, eTMF). Experience with Veeva Vault and Medidata RAVE, a plus Ability to travel up to 50-70% depending on study requirements. Company Join an innovative, rapidly expanding, clinical-stage medical device company and be part of something revolutionary!
