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Clinical Trial Risk Based Monitoring Jobs in Colorado

CPC Clinical Research

Clinical Operations Manager II

Aurora, CO · Remote

$88K/mo

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Define and monitor project scope, timelines and deliverables from project initiation to close-out ... Oversee trial-related activities. * Track and approve vendor payments. * Provide expert advice in ...

CPC Clinical Research

Clinical Operations Manager II

Aurora, CO · On-site

$71K - $88K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Define and monitor project scope, timelines and deliverables from project initiation to close-out ... Oversee trial-related activities. * Track and approve vendor payments. * Provide expert advice in ...

CPC Clinical Research

Sr. Clinical Operations Manager

Aurora, CO · On-site

$95K - $118K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Review and finalize monitoring visit reports and follow-up letters with Clinical Research ... Oversee trial-related activities and provide performance feedback to supervisors for all project ...

CPC Clinical Research

Sr. Clinical Operations Manager

Aurora, CO · On-site +1

$118K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Review and finalize monitoring visit reports and follow-up letters with Clinical Research ... Oversee trial-related activities and provide performance feedback to supervisors for all project ...

CPC

Clinical Operations Manager II

Aurora, CO · Remote

$71K - $88K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Define and monitor project scope, timelines and deliverables from project initiation to close-out ... Oversee trial-related activities. * Track and approve vendor payments. * Provide expert advice in ...

Panorama Eye Care

Manager, Clinical Research

Fort Collins, CO · On-site

$70K - $78K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... as clinical trial investigators through the conduct of accurate and ethical studies. This ... Works with study monitors to complete queries and action items. * Oversees IP accountability and ...

Panorama Eye Care LLC

Manager, Clinical Research

Fort Collins, CO · On-site

$70K - $78K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... as clinical trial investigators through the conduct of accurate and ethical studies. This ... Works with study monitors to complete queries and action items. * Oversees IP accountability and ...

Tigermed America

Clinical Research Associate

Denver, CO · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

This position is permanent, home-based, must be located in Washington/Oregon/ Colorado/Wyoming ... Obtains regulatory documentation for successful implementation, monitoring, and evaluation of ...

Tigermed America

Clinical Research Associate

Denver, CO · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

This position is permanent, home-based, must be located in Washington/Oregon/ Colorado/Wyoming ... Obtains regulatory documentation for successful implementation, monitoring, and evaluation of ...

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Clinical Trial Risk Based Monitoring information

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.

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.

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 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 are popular job titles related to Clinical Trial Risk Based Monitoring jobs in Colorado?

For Clinical Trial Risk Based Monitoring jobs in Colorado, the most frequently searched job titles are:

What job categories do people searching Clinical Trial Risk Based Monitoring jobs in Colorado look for?

The top searched job categories for Clinical Trial Risk Based Monitoring jobs in Colorado are:

What cities in Colorado are hiring for Clinical Trial Risk Based Monitoring jobs?

Cities in Colorado with the most Clinical Trial Risk Based Monitoring job openings:

Clinical Trial Risk Based Monitoring jobs near you

Sr. Clinical Specialist, Surgical Operations (Mountain West)

Aspen Neuroscience

Denver, CO • On-site

$136K - $167K/yr

Full-time

Dental

Re-posted 16 days ago

Job description

Aspen is seeking a Senior Clinical Specialist, Surgical Operations as a founding member of a field team supporting neurosurgical procedures for Parkinson's cell therapy studies. We are looking for candidates who are eager to translate field experience into scalable standards, influencing training, workflows, and operational strategy across the clinical program. This ideal candidate operates with a high degree of autonomy, partnering closely with investigators, surgeons, and cross-functional stakeholders to lead site readiness, procedural execution, and continuous improvement of surgical delivery practices. Roles are currently open in the Great Lakes Region (WI/IL/MI/OH), Mountain West (Denver/Phoenix), Northeast (NY), and Southwest (FL/TX).
DUTIES AND RESPONSIBILITIES:
  • Serve as the lead field-based clinical and technical expert across assigned sites, providing advanced guidance on surgical workflow, protocol execution, and complex case management while setting expectations for execution consistency

  • Lead site onboarding, advanced training, and ongoing capability development for investigators, surgeons, and multidisciplinary teams, ensuring alignment to standardized procedural practices and trial requirements. Including surgical workflow, intraoperative imaging, cell preparation and handling requirements, and the surgical delivery components of protocol execution and documentation.

  • Drive site pre-case readiness across scheduling, staffing, materials, imaging coordination, and procedural flow, proactively identifying and mitigating execution risks and closing readiness gaps.

  • Provide advanced onsite support during complex neurosurgical procedures, delivering real time guidance, addressing workflow deviations, and resolving procedural or protocol-related issues.

  • Ensure consistent application of protocol requirements, patient safety standards, and data integrity expectations across sites, reinforcing compliance while influencing best practices.

  • Establish and maintain strong relationships with principal investigators, neurosurgeons, and key hospital stakeholders, acting as a trusted clinical advisor and representative of the Company's surgical delivery model.

  • Synthesize field insights, procedural trends, and site-level challenges to inform cross functional decision-making, influencing Clinical Operations, Clinical Development, Medical, Quality, and Regulatory strategies.

  • Lead continuous improvement initiatives by translating field experience into enhancements to training programs, procedural workflows, tools, and site readiness models. • Contribute to the development and standardization of the Company's surgical delivery model across the clinical network, ensuring scalability and consistency as trials expand.

  • Informally mentor and guide junior clinical specialists and cross-functional partners, sharing expertise and reinforcing best practices across the team.

  • Support trial expansion strategy, including site activation, network scaling, and investigator engagement, while ensuring readiness and execution quality across new and existing sites.

  • Provide thought partnership in internal case reviews, risk discussions, and cross-functional planning, contributing to trial design considerations and execution strategy.

EDUCATION AND EXPERIENCE:
  • Bachelor's degree in biomedical engineering, nursing, neuroscience, life sciences, or a related field required; advanced degree (e.g., MSN, PA, NP, PhD) preferred.

  • Minimum of 10 years of progressively responsible experience in field clinical support, surgical support, clinical applications, or trial-facing procedural roles within complex, procedure driven environments (e.g., neurosurgery, implantable therapies, image-guided interventions).

  • Extensive hands-on experience supporting high-acuity neurosurgical or interventional procedures; deep familiarity with cranial, stereotactic, or intracranial delivery workflows strongly preferred.

  • Demonstrated experience operating in regulated clinical trial environments, including application of GCP, protocol adherence, SOPs, and documentation requirements.

  • Experience supporting early-phase or first-in-human studies, MRI-guided workflows, or advanced therapy delivery (cell or gene therapy), and contributing to development of field procedures, training programs, or site readiness processes.

JOB SPECIFICATIONS:
  • Judgment & Execution: Advanced judgment in high-risk surgical settings, including live-case decision-making, deviation management, and timely escalation.

  • Clinical & Procedural Expertise: Deep expertise in neurosurgical workflows, clinical trial execution, and investigational product delivery in complex procedural environments.

  • Strategic Execution: Ability to translate clinical protocols into scalable operating models that support consistent execution across sites.

  • Training & Capability Development: Ability to develop scalable training and site readiness approaches that build procedural capability across clinical teams.

  • Communication & Influence: Ability to communicate complex clinical and operational information clearly and persuasively across stakeholder groups.

  • Cross-Functional Influence: Ability to translate field insights into clinical and operational strategies that shape cross-functional decisions.

  • Protocol Interpretation: Ability to interpret complex protocols and apply requirements to practical, compliant site execution.

  • Stakeholder Engagement: Ability to build credibility and trusted relationships with investigators, surgeons, and site leaders.

  • Problem Solving & Escalation: Strong problem-solving skills, including the ability to assess issues, determine next steps, and escalate appropriately.

  • Documentation & Compliance: Strong knowledge of documentation and compliance standards related to patient safety, data integrity, and investigational product handling.

  • Adaptability: Ability to remain effective and composed in dynamic, high-pressure surgical environments.

  • Travel & Field Engagement: Willingness and ability to travel extensively in support of clinical sites and procedural activities.

WORKING CONDITIONS
Clinical and surgical environments, including hospital, operating room, and MRI settings. This role requires frequent travel to domestic clinical sites (approximately 50%).
PHYSICAL DEMANDS
While performing the duties of this Job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. These work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job.
EEO and Employment Eligibility:
Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees. Aspen is not able to provide visa sponsorship for this role. Applicants must have valid work authorization that does not require employer sponsorship now or in the future.
Total Rewards and Culture:
Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.
The anticipated salary range for candidates who will work in San Diego is $136,800-$167,200 annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.

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