Regional Clinical Research Associate II

Responsibilities

• Conduct on-site, remote, and centralized monitoring to ensure compliance with FDA regulations, ICH/GCP guidelines, BIOTRONIK procedures, and IRB/EC policies.
• Schedule and complete monitoring visits within established timelines in alignment with risk-based monitoring plans and internal procedures.
• Identify data discrepancies and compliance issues; communicate findings to site staff, provide retraining where necessary, and develop effective resolution strategies.
• Escalate significant issues to the study team and department management through appropriate channels, including monitoring visit reports.
• Collaborate 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.

Requirements

• Bachelor’s degree or higher level degree in nursing, life sciences or related medical/scientific field.
• Valid US driver’s license.
• Minimum of 3 years on-site monitoring research experience for a CRO, Pharma, or Medical Device company. 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.
• 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.
• Current certification as a Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP).
• 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.

Qualifications

• Approximately 75% travel required throughout the United States to investigational centers and BIOTRONIK, Inc. corporate office. Travel frequency may vary based on study needs and may include air, ground, or rail travel.

Benefits

BIOTRONIK offers competitive benefits including health insurance, retirement plans, and paid time off.

Pay

Compensation is commensurate with experience.

Schedule

Full-time position.