Regional Clinical Research Associate II, Medical Devices & Cardiology
Overview
Owns regional on-site, remote, and centralized monitoring to ensure compliance with FDA regulations, ICH GCP guidelines, BIOTRONIK procedures, and IRB EC policies. Supports cardiac rhythm management studies by ensuring data integrity and subject safety across electrophysiology and vascular interventional cardiology. Works with Investigators, Coordinators, and cross functional teams to drive study execution and issue resolution. This role offers remote work with substantial travel and a patient focused impact at scale.
What You'll Do10
- 1Build and execute monitoring plans to evaluate protocol compliance, data accuracy, and subject safety across assigned studies.
- 2Identify data discrepancies and compliance gaps, communicate findings to site staff, provide retraining, and develop resolution strategies.
- 3Escalate significant issues to the study team and management with clear monitoring reports and action items.
- 4Collaborate with Investigators and Coordinators during visits to ensure compliance and timely issue resolution.
- 5Partner with BIOTRONIK Clinical Studies team to prepare for site visits and assess site performance.
- 6Present monitoring outcomes with actionable guidance and resolve data queries to achieve closure.
- 7Serve as a continuous resource to sites between visits for data queries and study requirements.
- 8Train and mentor BIOTRONIK staff on monitoring processes and best practices and conduct site training and co monitoring visits
- 9Complete monitoring documentation including reports and follow up letters per BIOTRONIK standards
- 10Support audits investigator meetings and training activities in collaboration with the CRA group manager
Requirements10
- 1Bachelor's degree or higher in nursing life sciences or related medical scientific field
- 2Valid US driver’s license
- 3Minimum of 3 years on site monitoring experience for a CRO Pharma or Medical Device company
- 4Experience supporting medical device IDE trials preferred
- 5Strong clinical trial monitoring experience in electrophysiology or vascular interventional cardiology preferred
- 6Experience monitoring FIH IDE post approval and post market studies
- 7Solid knowledge of GCP ICH FDA regulations including 21 CFR 11 50 54 56 812 820 and ISO standards for medical device clinical trials
- 8Current certification as a CCRA or CCRP
- 9Strong clinical terminology knowledge and ability to work independently with minimal supervision in a regional territory
- 10Excellent interpersonal communication and problem solving skills
Salary Insight
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