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 ...
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 ...
Regional Director of Clinical Services
Woodburn, OR ยท On-site
$160K/yr
Regional Director of Clinical Services (RN) - Northern Oregon Serving Woodburn, Keizer, Corvallis, and Eugene Salary: $160,000/YR+ (DOE) Volare Health is looking for an experienced and driven ...
Regional Director of Clinical Services
Woodburn, OR ยท On-site
$160K/yr
Regional Director of Clinical Services (RN) - Northern Oregon Serving Woodburn, Keizer, Corvallis, and Eugene Salary: $160,000/YR+ (DOE) Volare Health is looking for an experienced and driven ...
Regional Health and Wellness Director (RN)
Antelope, OR ยท On-site
$130 - $150/hr
Provide clinical expertise and support to community Health and Wellness Directors and other healthcare staff.Conduct regular site visits to assess clinical operations, resident care, and regulatory ...
New
Regional Health and Wellness Director (RN)
Antelope, OR ยท On-site
$130 - $150/hr
Provide clinical expertise and support to community Health and Wellness Directors and other healthcare staff.Conduct regular site visits to assess clinical operations, resident care, and regulatory ...
New
Regional Home Manager
Portland, OR ยท On-site
Drive Clinical Outcomes * Monitor, and conduct trend analysis of clinical outcomes * Report out on ... Work with Regional Operations Director and Facility Administrators to manage labor among clinic ...
Regional Home Manager
Portland, OR ยท On-site
Drive Clinical Outcomes * Monitor, and conduct trend analysis of clinical outcomes * Report out on ... Work with Regional Operations Director and Facility Administrators to manage labor among clinic ...
Regional Home Manager
Portland, OR ยท On-site
Drive Clinical Outcomes * Monitor, and conduct trend analysis of clinical outcomes * Report out on ... Work with Regional Operations Director and Facility Administrators to manage labor among clinic ...
Regional Home Manager
Portland, OR ยท On-site
Drive Clinical Outcomes * Monitor, and conduct trend analysis of clinical outcomes * Report out on ... Work with Regional Operations Director and Facility Administrators to manage labor among clinic ...
Area Quality Specialist - RN
Medford, OR ยท On-site
$115K/yr
Quality Nurse, Nurse Educator, Area Quality Specialist, Regional Quality Specialist, Regional Clinical Quality Manager, Regional Clinical Quality Specialist, Regional Director of Quality Assurance ...
Area Quality Specialist - RN
Medford, OR ยท On-site
$115K/yr
Quality Nurse, Nurse Educator, Area Quality Specialist, Regional Quality Specialist, Regional Clinical Quality Manager, Regional Clinical Quality Specialist, Regional Director of Quality Assurance ...
As a Lead Clinical Research Associate, you'll provide leadership, oversight, and mentorship across regional clinical trials while partnering closely with Project Managers, Regional Project Leads ...
Quick apply
As a Lead Clinical Research Associate, you'll provide leadership, oversight, and mentorship across regional clinical trials while partnering closely with Project Managers, Regional Project Leads ...
Clinical Nurse Educator
$55.98 - $83.96/hr
As a Clinical Nurse Educator at Sacred Heart Medical Center, you'll be part of a collaborative ... Sacred Heart Medical Center at Riverbend is a 350-bed acute care regional medical center with a ...
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Clinical Nurse Educator
$55.98 - $83.96/hr
As a Clinical Nurse Educator at Sacred Heart Medical Center, you'll be part of a collaborative ... Sacred Heart Medical Center at Riverbend is a 350-bed acute care regional medical center with a ...
Clinical Nurse Educator
Springfield, OR ยท On-site
$40.50 - $55.25/hr
As a Clinical Nurse Educator at Sacred Heart Medical Center, you'll be part of a collaborative ... Sacred Heart Medical Center at Riverbend is a 350-bed acute care regional medical center with a ...
Clinical Nurse Educator
Springfield, OR ยท On-site
$40.50 - $55.25/hr
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This position can cover any CVAC case in the territory, region, or at times, the nation, as assigned. The Clinical Specialist will also provide clinical support for physician training and sales ...
New
Quick apply
This position can cover any CVAC case in the territory, region, or at times, the nation, as assigned. The Clinical Specialist will also provide clinical support for physician training and sales ...
New
Support execution of regional clinical, sales and service strategies to improve customer experience and drive product adoption. * Serve as a clinical resource by providing case coverage, product ...
New
Support execution of regional clinical, sales and service strategies to improve customer experience and drive product adoption. * Serve as a clinical resource by providing case coverage, product ...
New
Support execution of regional clinical, sales and service strategies to improve customer experience and drive product adoption. * Serve as a clinical resource by providing case coverage, product ...
New
Support execution of regional clinical, sales and service strategies to improve customer experience and drive product adoption. * Serve as a clinical resource by providing case coverage, product ...
New
Support execution of regional clinical, sales and service strategies to improve customer experience and drive product adoption. * Serve as a clinical resource by providing case coverage, product ...
New
Support execution of regional clinical, sales and service strategies to improve customer experience and drive product adoption. * Serve as a clinical resource by providing case coverage, product ...
New
Support execution of regional clinical, sales and service strategies to improve customer experience and drive product adoption. Serve as a clinical resource by providing case coverage, product ...
New
Support execution of regional clinical, sales and service strategies to improve customer experience and drive product adoption. Serve as a clinical resource by providing case coverage, product ...
New
Clinical Sales - Surgeons (Commission) Job Category: People Leader All Job Posting Locations ... Direct the region's sales activities that result in meeting annual growth and revenue objectives
Clinical Sales - Surgeons (Commission) Job Category: People Leader All Job Posting Locations ... Direct the region's sales activities that result in meeting annual growth and revenue objectives
Regional Director- Northwest
Portland, OR ยท On-site
$150K/yr
Clinical Sales - Surgeons (Commission) Job Category: People Leader All Job Posting Locations ... Direct the region's sales activities that result in meeting annual growth and revenue objectives
Regional Director- Northwest
Portland, OR ยท On-site
$150K/yr
Clinical Sales - Surgeons (Commission) Job Category: People Leader All Job Posting Locations ... Direct the region's sales activities that result in meeting annual growth and revenue objectives
Physical Therapist
Portland, OR ยท On-site
$64 - $80/hr
If less than one year of experience, approval from regional clinical leaders is required as well as appropriate mentoring and/or participating in a residency program. * Current CPR certification. Our ...
Physical Therapist
Portland, OR ยท On-site
$64 - $80/hr
If less than one year of experience, approval from regional clinical leaders is required as well as appropriate mentoring and/or participating in a residency program. * Current CPR certification. Our ...
Clinical Supervisor - OR - LCSW - Remote
OR ยท On-site +1
$72.44/hr
Collaboration with the Regional Clinical Director regarding any performance issues. Qualifications * Ability to be appropriately assertive in coaching residents on professional and clinical goals
Clinical Supervisor - OR - LCSW - Remote
OR ยท On-site +1
$72.44/hr
Collaboration with the Regional Clinical Director regarding any performance issues. Qualifications * Ability to be appropriately assertive in coaching residents on professional and clinical goals
Physical Therapist
Portland, OR ยท On-site
$64 - $80/hr
If less than one year of experience, approval from regional clinical leaders is required as well as appropriate mentoring and/or participating in a residency program. * Current CPR certification. Our ...
Physical Therapist
Portland, OR ยท On-site
$64 - $80/hr
If less than one year of experience, approval from regional clinical leaders is required as well as appropriate mentoring and/or participating in a residency program. * Current CPR certification. Our ...
Physical Therapist Assistant - Columbia County
Portland, OR ยท On-site
$44.11 - $55.06/hr
If less than one year of experience, approval from regional clinical leaders is required as well as appropriate mentoring and/or participating in a residency program. * Current CPR certification. Our ...
Physical Therapist Assistant - Columbia County
Portland, OR ยท On-site
$44.11 - $55.06/hr
If less than one year of experience, approval from regional clinical leaders is required as well as appropriate mentoring and/or participating in a residency program. * Current CPR certification. Our ...
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Full-time
Re-posted 9 days ago
Key responsibilities
Conduct monitoring activities to evaluate protocol compliance, data accuracy, and subject safety through review of regulatory documents, medical records, reported data, and investigational device accountability.
Manage all monitoring responsibilities for assigned clinical studies, including scheduling visits, identifying discrepancies, communicating findings, and escalating issues.
Collaborate with investigators, research coordinators, and cross-functional teams to ensure compliance, address findings, and support study execution.
Job description
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
- 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
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.