Career Opportunities: Regional Clinical Research Associate II (62419)
Requisition ID 62419 - Posted 06/26/2026 - Posting Country (1) - Work Location (1) - Clinical Studies - Undefined - Full-time - Professionals - BIOTRONIK
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Regional Clinical Research Associate II
BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.
BIOTRONIK is looking to add a Regional Clinical Research Associate II to our Clinical Studies team. Conduct on-site, remote, and centralized monitoring to ensure compliance with FDA regulations, ICH/GCP guidelines, BIOTRONIK procedures, and IRB/EC policies. Supports clinical studies in cardiac rhythm management and related areas by ensuring data integrity, subject safety, and protocol adherence.
Your Responsibilities:
Conduct monitoring activities in accordance with BIOTRONIK procedures and applicable regulations to evaluate protocol compliance, data accuracy, and subject safety through review of regulatory documents, medical records, reported data, and investigational device accountability (as applicable).
Manage all monitoring responsibilities for assigned clinical studies, including:
Scheduling and completing monitoring visits within established timelines in alignment with risk-based monitoring plans and internal procedures.
Identifying data discrepancies and compliance issues; communicating findings to site staff, providing retraining where necessary, and developing effective resolution strategies.
Escalating significant issues to the study team and department management through appropriate channels, including monitoring visit reports.
Collaborate closely with Investigators and Research Coordinators during monitoring visits to ensure compliance, address findings, and support timely issue resolution.
Partner with BIOTRONIK Clinical Studies team members to prepare for site visits, proactively assess site performance, and escalate critical findings.
Present monitoring outcomes to site staff with clear guidance on corrective actions; review and resolve data queries to ensure mutual understanding and closure.
Serve as an ongoing resource to study sites between visits, providing guidance on data queries, action items, and study requirements.
Train and mentor BIOTRONIK staff on monitoring processes and best practices; conduct site training and co-monitoring visits as requested.
Complete all required documentation, including monitoring reports, follow-up letters, and action items, in accordance with BIOTRONIK standards.
Support departmental and study-related initiatives, including audits, investigator meetings, and training activities, in collaboration with the Manager, CRA Group.
Interface effectively with cross-functional teams, including Clinical, Regulatory, Sales, and site personnel, to support study execution.
Your Profile
Solid knowledge of medical terminology.
Travel
Location
Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.
Location: Midwest, southwest or Southeast, United States | Working hours: Full-time | Type of contract: Undefined
Apply now under: www.biotronik.com/careers
Job ID: 62419 | BIOTRONIK Inc. | United States (US)
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law. Please note that applications sent by post will only be returned if a sufficiently stamped self-addressed envelope is included.
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Regional Clinical Research Associate II
BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.
BIOTRONIK is looking to add a Regional Clinical Research Associate II to our Clinical Studies team. Conduct on-site, remote, and centralized monitoring to ensure compliance with FDA regulations, ICH/GCP guidelines, BIOTRONIK procedures, and IRB/EC policies. Supports clinical studies in cardiac rhythm management and related areas by ensuring data integrity, subject safety, and protocol adherence.
Your Responsibilities:
Conduct monitoring activities in accordance with BIOTRONIK procedures and applicable regulations to evaluate protocol compliance, data accuracy, and subject safety through review of regulatory documents, medical records, reported data, and investigational device accountability (as applicable).
Manage all monitoring responsibilities for assigned clinical studies, including:
Scheduling and completing monitoring visits within established timelines in alignment with risk-based monitoring plans and internal procedures.
Identifying data discrepancies and compliance issues; communicating findings to site staff, providing retraining where necessary, and developing effective resolution strategies.
Escalating significant issues to the study team and department management through appropriate channels, including monitoring visit reports.
Collaborate closely with Investigators and Research Coordinators during monitoring visits to ensure compliance, address findings, and support timely issue resolution.
Partner with BIOTRONIK Clinical Studies team members to prepare for site visits, proactively assess site performance, and escalate critical findings.
Present monitoring outcomes to site staff with clear guidance on corrective actions; review and resolve data queries to ensure mutual understanding and closure.
Serve as an ongoing resource to study sites between visits, providing guidance on data queries, action items, and study requirements.
Train and mentor BIOTRONIK staff on monitoring processes and best practices; conduct site training and co-monitoring visits as requested.
Complete all required documentation, including monitoring reports, follow-up letters, and action items, in accordance with BIOTRONIK standards.
Support departmental and study-related initiatives, including audits, investigator meetings, and training activities, in collaboration with the Manager, CRA Group.
Interface effectively with cross-functional teams, including Clinical, Regulatory, Sales, and site personnel, to support study execution.
Your Profile
Solid knowledge of medical terminology.
Travel
Location
Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.
Location: Midwest, southwest or Southeast, United States | Working hours: Full-time | Type of contract: Undefined
Apply now under: www.biotronik.com/careers
Job ID: 62419 | BIOTRONIK Inc. | United States (US)
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law. Please note that applications sent by post will only be returned if a sufficiently stamped self-addressed envelope is included.