Regional Clinical Research Associate II BIOTRONIK is one of the leading manufacturers of cardio ... Minimum of 3 years on-site monitoring research experience for a CRO, Pharma, or Medical Device ...
Regional Clinical Research Associate II BIOTRONIK is one of the leading manufacturers of cardio ... Minimum of 3 years on-site monitoring research experience for a CRO, Pharma, or Medical Device ...
Clinical Trial, Commercial & R&D Counsel (Pharma / Life Sciences)
OR · On-site +1
$309K/yr
Remote We are seeking experienced attorneys to support legal teams within the pharma and health systems space. This role focuses on drafting, reviewing, and negotiating a broad range of commercial ...
Clinical Trial, Commercial & R&D Counsel (Pharma / Life Sciences)
OR · On-site +1
$309K/yr
Remote We are seeking experienced attorneys to support legal teams within the pharma and health systems space. This role focuses on drafting, reviewing, and negotiating a broad range of commercial ...
In-House Clinical Research Associate (CRA)
OR · On-site +1
In-House Clinical Research Associate (CRA) Location: This position may be performed remotely but ... biotech, pharma, or CRO settings. * Solid knowledge of GCP, ICH guidelines, and regulatory ...
New
In-House Clinical Research Associate (CRA)
OR · On-site +1
In-House Clinical Research Associate (CRA) Location: This position may be performed remotely but ... biotech, pharma, or CRO settings. * Solid knowledge of GCP, ICH guidelines, and regulatory ...
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Quality Inspector
Clackamas, OR · On-site
Quality experience in food, nutraceutical, manufacturing, biotech, or pharma * Experience with FDA ... Associate's degree in related field + 4 years of relevant experience INDBH #LI-DNI
Quality Inspector
Clackamas, OR · On-site
Quality experience in food, nutraceutical, manufacturing, biotech, or pharma * Experience with FDA ... Associate's degree in related field + 4 years of relevant experience INDBH #LI-DNI
Associate Director, Analytical Development
OR · On-site +1
Position Overview: Reporting to the Director, Product Development, the Associate Director ... in the biotech/pharma or related industry is required. * Experience with inhalation drug ...
Associate Director, Analytical Development
OR · On-site +1
Position Overview: Reporting to the Director, Product Development, the Associate Director ... in the biotech/pharma or related industry is required. * Experience with inhalation drug ...
Senior Account Executive
OR · On-site +1
Mentor Associate and mid-level Account Executives * You will represent the company at industry ... Deep knowledge of pharma, biotech, or regulated industries * Strong executive presence and ...
Senior Account Executive
OR · On-site +1
Mentor Associate and mid-level Account Executives * You will represent the company at industry ... Deep knowledge of pharma, biotech, or regulated industries * Strong executive presence and ...
Contracts Counsel - Hospitals/Healthcare Providers
OR · On-site +1
$309K/yr
... Associate Agreements (BAAs), Non-Disclosure Agreements (NDAs), and Requests for Proposals (RFPs ... Utilize expertise in managed care to influence supply chain management, specialty pharma ...
Contracts Counsel - Hospitals/Healthcare Providers
OR · On-site +1
$309K/yr
... Associate Agreements (BAAs), Non-Disclosure Agreements (NDAs), and Requests for Proposals (RFPs ... Utilize expertise in managed care to influence supply chain management, specialty pharma ...
The Associate Director, Sales Operations & Execution serves as a key strategic partner and ... within pharma/biotech preferred. * Proven track record supporting senior commercial or sales ...
The Associate Director, Sales Operations & Execution serves as a key strategic partner and ... within pharma/biotech preferred. * Proven track record supporting senior commercial or sales ...
Associate Account Manager - Clinical Trial Division - West Coast, US
OR · On-site +1
$76K - $115K/yr
Location/Division Specific Information This opportunity supports the Clinical Trial Division within the Pharma Services Group (PSG) at Thermo Fisher Scientific. Ideally, you will be remotely located ...
Associate Account Manager - Clinical Trial Division - West Coast, US
OR · On-site +1
$76K - $115K/yr
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Research Assistant
Portland, OR · On-site
$23.18 - $33.02/hr
... pharma stakeholders. Experience with primary sample cell culture methods, flow cytometry, and data ... Bachelor's in relevant field OR Associate's AND 3 years of relevant experience OR 4 years of ...
Research Assistant
Portland, OR · On-site
$23.18 - $33.02/hr
... pharma stakeholders. Experience with primary sample cell culture methods, flow cytometry, and data ... Bachelor's in relevant field OR Associate's AND 3 years of relevant experience OR 4 years of ...
Research Assistant
Portland, OR · On-site
$20.50 - $28/hr
... pharma stakeholders. Experience with primary sample cell culture methods, flow cytometry, and data ... Bachelor's in relevant field OR Associate's AND 3 years of relevant experience OR 4 years of ...
Research Assistant
Portland, OR · On-site
$20.50 - $28/hr
... pharma stakeholders. Experience with primary sample cell culture methods, flow cytometry, and data ... Bachelor's in relevant field OR Associate's AND 3 years of relevant experience OR 4 years of ...
Research Assistant
Portland, OR · On-site
$20.50 - $28/hr
... pharma stakeholders. Experience with primary sample cell culture methods, flow cytometry, and data ... Bachelor's in relevant field OR Associate's AND 3 years of relevant experience OR 4 years of ...
Research Assistant
Portland, OR · On-site
$20.50 - $28/hr
... pharma stakeholders. Experience with primary sample cell culture methods, flow cytometry, and data ... Bachelor's in relevant field OR Associate's AND 3 years of relevant experience OR 4 years of ...
Research Assistant
Portland, OR · On-site
$20.50 - $28/hr
... pharma stakeholders. Experience with primary sample cell culture methods, flow cytometry, and data ... Bachelor's in relevant field OR Associate's AND 3 years of relevant experience OR 4 years of ...
Research Assistant
Portland, OR · On-site
$20.50 - $28/hr
... pharma stakeholders. Experience with primary sample cell culture methods, flow cytometry, and data ... Bachelor's in relevant field OR Associate's AND 3 years of relevant experience OR 4 years of ...
Research Assistant
Portland, OR · On-site
$20.50 - $28/hr
... pharma stakeholders. Experience with primary sample cell culture methods, flow cytometry, and data ... Bachelor's in relevant field OR Associate's AND 3 years of relevant experience OR 4 years of ...
Research Assistant
Portland, OR · On-site
$20.50 - $28/hr
... pharma stakeholders. Experience with primary sample cell culture methods, flow cytometry, and data ... Bachelor's in relevant field OR Associate's AND 3 years of relevant experience OR 4 years of ...
... pharma, clean room, medical, power production, etc.) * Bachelor's Degree, Associates Degree, Trade Certification or state licensure in Electrical or Mechanical (HVAC) * Knowledge of mechanical ...
... pharma, clean room, medical, power production, etc.) * Bachelor's Degree, Associates Degree, Trade Certification or state licensure in Electrical or Mechanical (HVAC) * Knowledge of mechanical ...
Immunology Sales Specialist (Oregon) - Ophthalmology, Neurology
Portland, OR · On-site +1
$101K - $145K/yr
Carry out duties and responsibilities in compliance with applicable regulations and Pharma ... Ophthalmology, Neurology In lieu of a Bachelor's degree, will consider either an Associate's Degree ...
Immunology Sales Specialist (Oregon) - Ophthalmology, Neurology
Portland, OR · On-site +1
$101K - $145K/yr
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Service Field Technician I (29367)
Portland, OR · On-site
$52K - $75K/yr
... and Pharma/Healthcare Industry. Our Technical Site Services group specializes in cleanroom ... associates. We are committed to equal employment opportunity regardless of race, color, ancestry ...
Service Field Technician I (29367)
Portland, OR · On-site
$52K - $75K/yr
... and Pharma/Healthcare Industry. Our Technical Site Services group specializes in cleanroom ... associates. We are committed to equal employment opportunity regardless of race, color, ancestry ...
Associate's degree in engineering plus 5+ years experience or Bachelor's degree in related field ... pharma, clean room, medical, power production, etc.) * Professional affiliations (7x24 Exchange ...
Associate's degree in engineering plus 5+ years experience or Bachelor's degree in related field ... pharma, clean room, medical, power production, etc.) * Professional affiliations (7x24 Exchange ...
Immunology Sales Specialist (Oregon) - Ophthalmology, Neurology
Portland, OR · Remote
$101K - $145K/yr
Carry out duties and responsibilities in compliance with applicable regulations and Pharma ... Ophthalmology, Neurology In lieu of a Bachelor's degree, will consider either an Associate's Degree ...
Immunology Sales Specialist (Oregon) - Ophthalmology, Neurology
Portland, OR · Remote
$101K - $145K/yr
Carry out duties and responsibilities in compliance with applicable regulations and Pharma ... Ophthalmology, Neurology In lieu of a Bachelor's degree, will consider either an Associate's Degree ...
Immunology Sales Specialist (Northwest) - Nephrology
Portland, OR · Remote
$111K - $159K/yr
Carry out duties and responsibilities in compliance with applicable regulations and Pharma ... In lieu of a Bachelor's degree, will consider either an Associate's Degree and 5+ years, OR 7+ ...
Immunology Sales Specialist (Northwest) - Nephrology
Portland, OR · Remote
$111K - $159K/yr
Carry out duties and responsibilities in compliance with applicable regulations and Pharma ... In lieu of a Bachelor's degree, will consider either an Associate's Degree and 5+ years, OR 7+ ...
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Full-time
Re-posted 24 days ago
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.