Regional Clinical Research Associate II

Biotronik•Oswego, IL

42d•Remote

About The Position

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.

Requirements

Bachelor’s degree or higher level degree in nursing, life sciences or related medical/scientific field.
Must have a valid US driver’s license.
Minimum of 3 years on-site monitoring research experience for a CRO, Pharma, or Medical Device company.
Strong understanding of GCP/ICH guidelines and FDA regulations, including 21 CFR Parts 11, 50, 54, 56, 812, and 820, as well as ISO standards for medical device clinical trials.
Solid knowledge of medical terminology.
Ability to work independently with minimal supervision in a regional territory.
Strong organizational, analytical, and problem-solving skills, with the ability to assess complex situations and develop effective solutions.
Excellent interpersonal and communication skills, with the ability to engage effectively with physicians, site staff, cross-functional teams, and leadership.
Ability to communicate protocol and regulatory requirements clearly and constructively.
Responsible for adequate and reasonable home office set up including dedicated desk space to accommodate work responsibilities and BIOTRONIK supplied equipment.

Nice To Haves

Experience supporting medical device IDE trials is preferred.
Strong clinical trial monitoring experience in relevant BIOTRONIK product and/or relevant therapeutic areas (electrophysiology and vascular interventional cardiology) preferred.
Demonstrated experience in clinical trial monitoring, preferably within electrophysiology, cardiology, or related therapeutic areas.
Experience monitoring first-in-human (FIH), investigational device exemption (IDE), post-approval, and/or post-market studies.
Current certification as a Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP).

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.