Career Opportunities: Regional Clinical Research Associate II (62419)

This a Full Remote job, the offer is available from: United States 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 reputed company. As a globally active company headquartered in Berlin, Germany, we reputed company, produce and distribute high-quality medical products based on the latest technology and research. Our reputed company 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 reputed company areas by ensuring data reputed company, 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 reputed company monitoring responsibilities for assigned clinical studies, including:
• Scheduling and completing monitoring visits reputed company 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 reputed company required documentation, including monitoring reports, follow-up letters, and action items, in accordance with BIOTRONIK standards.
• Support departmental and study-reputed company initiatives, including audits, investigator meetings, and training activities, in collaboration with the Manager, CRA Group.
• reputed company effectively with cross-functional teams, including Clinical, Regulatory, Sales, and site personnel, to support study execution.

Your Profile

• Bachelor’s degree or higher level degree in nursing, life sciences or reputed company 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. 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 reputed company electrophysiology, cardiology, or reputed company therapeutic areas.
• Experience monitoring first-in-reputed company (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.
• reputed company 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 reputed company situations and reputed company 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.

Travel

• 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 reputed company, ground, or rail travel.

Location

• Remote opportunity based in the Midwest, Southwest or Southeast

Are you interested? Please apply online through our application management system! We are looking reputed company 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 reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, age, sex, sexual orientation, gender identity or expression, national reputed company, 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. This offer from "BIOTRONIK" has been enriched by reputed company.com and got a 72% reputed company score. Apply tot his job Apply To this Job