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Clinical Trial Risk Based Monitoring Jobs in Portland, OR

Jade Biosciences

Director, Clinical Operations

Vancouver, WA · Remote

$215K - $240K/yr

This individual will manage trial budgets, vendor selection, and risk mitigation while contributing ... monitoring plans, informed consent forms, investigator brochures, clinical study reports) * Builds ...

IsoTalent

Clinical Research Coordinator

Portland, OR · On-site

$20 - $26/hr

Compensation: $20.00 - $26.00/hourly, based on experience * + quarterly bonuses based on site ... Performing laboratory tests as required by trial protocol * Monitoring clinical and laboratory data ...

Headlands Research

PRN Research Nurse

Portland, OR · On-site

As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and ... The infusion nurse is responsible for monitoring the study participant for infusion-related ...

Headlands Research

PRN Research Nurse

Portland, OR · On-site

As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and ... The infusion nurse is responsible for monitoring the study participant for infusion-related ...

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All JobsClinical Trial Risk Based Monitoring JobsClinical Trial Risk Based Monitoring Jobs in Portland, OR

Clinical Trial Risk Based Monitoring information

See Portland, OR salary details

$18

$42

$74

How much do clinical trial risk based monitoring jobs pay per hour?

As of Aug 6, 2026, the average hourly pay for clinical trial risk based monitoring in Portland, OR is $42.40, according to ZipRecruiter salary data. Most workers in this role earn between $34.18 and $46.63 per hour, depending on experience, location, and employer.

How does a clinical trial risk based monitoring professional typically collaborate with cross-functional teams during a study?

In a Clinical Trial Risk Based Monitoring role, you will regularly work with clinical research associates, data managers, statisticians, and regulatory teams to identify and address potential risks throughout a study. Collaboration often involves participating in meetings to review data trends, sharing insights about site performance, and helping to develop mitigation strategies. Effective communication is crucial, as you will be responsible for ensuring that all stakeholders are informed of key risks and recommended actions. This collaborative environment helps drive patient safety, data integrity, and overall trial success.

How to become a clinical trial risk based monitoring?

To become a clinical trial risk-based monitor, candidates typically need a bachelor's degree in life sciences, healthcare, or related fields, along with experience in clinical research or monitoring. Certification such as the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) can enhance job prospects. Strong knowledge of Good Clinical Practice (GCP) guidelines and proficiency with electronic data capture (EDC) systems are also important.

What is the difference between Clinical Trial Risk Based Monitoring vs Clinical Trial Data Manager?

AspectClinical Trial Risk Based MonitoringClinical Trial Data Manager
Primary FocusMonitoring trial sites for risks and complianceManaging and ensuring accuracy of trial data
Required SkillsMonitoring protocols, regulatory knowledge, site managementData management, database systems, quality control
Work EnvironmentClinical sites, monitoring visits, remote oversightData centers, clinical trial databases, office setting
CertificationsGCP, monitoring certificationsCDMP, data management certifications

While both roles are integral to clinical trials, Risk Based Monitoring focuses on overseeing site performance and compliance to mitigate risks, whereas Data Managers concentrate on managing and validating trial data for accuracy and integrity.

What is clinical trial risk based monitoring?

Clinical Trial Risk Based Monitoring (RBM) is a strategy used in clinical research to prioritize and focus monitoring activities on the most critical risks to patient safety and data integrity. Instead of monitoring every data point equally, RBM uses data analytics and risk assessment tools to identify which sites, processes, or data require more attention. This approach increases efficiency, reduces costs, and helps ensure that potential issues are detected and addressed promptly. RBM is supported by regulatory agencies and is increasingly adopted in both large and small clinical trials.

What are the key skills and qualifications needed to thrive in clinical trial risk based monitoring, and why are they important?

To thrive in Clinical Trial Risk Based Monitoring, you need expertise in clinical research, regulatory compliance, and data analysis, usually supported by a degree in life sciences or related fields. Familiarity with risk assessment tools, EDC (Electronic Data Capture) systems, and GCP (Good Clinical Practice) certification is typically required. Strong attention to detail, critical thinking, and effective communication help professionals proactively identify and address potential risks in trials. These skills are crucial for maintaining data integrity, ensuring patient safety, and optimizing the efficiency and quality of clinical studies.
What are popular job titles related to Clinical Trial Risk Based Monitoring jobs in Portland, OR? For Clinical Trial Risk Based Monitoring jobs in Portland, OR, the most frequently searched job titles are:
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Clinical Trial Risk Based Monitoring jobs near you

Regional Clinical Research Associate II

Biotronik

Lake Oswego, OR • On-site

Full-time

Re-posted 10 days ago

Job description

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 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.

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