Regional Clinical Research Associate II

Job description

• 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.

Required profile

• 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. 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.

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 air, ground, or rail travel.

Location

Remote opportunity based in the Midwest, Southwest or Southeast

Company description

At BIOTRONIK Neuro, we're ready to redefine relief for patients experiencing chronic pain. Leveraging BIOTRONIK's advanced cardiovascular technologies, BIOTRONIK Neuro has created a new approach to SCS therapy management: one that's not just implanted, but truly connected to the needs of patients and providers.

BIOTRONIK Neuro is looking to add Clinical Specialist to our Neuromodulation Segment in Indiana (also recruiting for additional locations, see website). As a member of the clinical support team, you'll be responsible for providing technical clinical expertise and support of the sales process to colleagues, current customers and/or potential customers. Works under general direction with clinical and sales teammates to identify and capitalize on sales opportunities by creating competency, comfort and expertise with all Biotronik NRO among physicians, support staff and customers within assigned geography. Performs work that involves a high degree of independence. Exercises independent judgment in planning, organizing, and performing work. Seeks to continually improve territory efficiency.

What we offer

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:

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.