Senior Clinical Research Associate job at Inogen in US National
Senior Clinical Research Associate
Job Type: Full-Time
Category: Medical Affairs
Location: Remote, United States
Description
The Senior Clinical Research Associate (CRA) is responsible for the independent oversight and management of clinical trial sites to ensure compliance with protocol, ICH GCP, applicable regulations, and internal SOPs. This role requires a highly experienced clinical professional who can operate with minimal supervision, provide leadership across studies, proactively identify and mitigate risks, and serve as a key liaison between sites, Clinical Operations, Quality, and cross-functional stakeholders.
Key Responsibilities
Clinical Trial Oversight
Independently manage assigned clinical trial sites from start-up through close-out
Perform site qualification, initiation, routine monitoring, and close-out visits
Ensure subject safety, data integrity, and protocol compliance at all assigned sites
Review source documentation, CRFs, and EDC entries for accuracy, completeness, and timeliness
Site & Investigator Management
Serve as the primary point of contact for investigators and site staff
Build strong, collaborative relationships with site teams
Provide advanced guidance and problem-solving support to sites without escalation when possible
Identify site performance issues early and implement corrective actions
Quality & Compliance
Ensure compliance with ICH GCP, FDA regulations, ISO 14155 (as applicable), and internal procedures
Identify, document, and escalate protocol deviations, safety issues, and quality risks
Support audits and inspections (FDA, internal, external) as a subject matter expert
Contribute to CAPAs, risk mitigation strategies, and continuous improvement initiatives
Leadership & Mentorship
Act as a Lead CRA across multiple device studies
Mentor and provide functional guidance to junior CRAs and CTAs
Support training, onboarding, and development of less experienced monitoring staff
Contribute to monitoring strategy development and process optimization
Cross-Functional Collaboration
Partner closely with Clinical Operations, Quality, Regulatory, Data Management, and Medical Affairs
Provide operational input into study planning, monitoring plans, and timelines
Escalate risks proactively with proposed mitigation strategies
Required Qualifications
Bachelor’s degree in life sciences, nursing, or related field (Master’s preferred)
7–10+ years of progressive clinical research experience as a CRA
Demonstrated ability to manage sites independently with minimal supervision
Extensive experience monitoring Phase I–IV clinical trials and/or medical device studies
Strong working knowledge of ICH GCP, FDA regulations, and applicable ISO 14155 standards
Proven experience supporting audits and regulatory inspections
Preferred Qualifications
Prior experience serving as a Lead CRA or Senior CRA on multiple studies
Experience mentoring or leading junior CRAs
Medical device and/or reimbursement study experience
Experience working in startup or fast-paced environments
Familiarity with EDC systems (e.g., Master Control, RedCap, Medidata Rave, Veeva Vault, Oracle Clinical)
Key Competencies
High degree of autonomy and accountability
Strong critical thinking and risk-based monitoring skills
Excellent written and verbal communication
Ability to prioritize, manage multiple studies, and meet deadlines
Professional judgment and decision-making capability
Travel Requirements
Up to 50–70% travel, as required by study needs
Inogen assesses market data to ensure a competitive compensation package for our employees. The base salary for this position is expected to be between $114,000.00 and $132,000.00 annually. However, actual base salary if hired will be determined on an individualized basis and will be based on non-discriminatory factors, including as to individual skills, education, experience and market location.
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