Job Title: Senior Clinical Research Associate (CRA)
Summary
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.
Our Benefits and Rewards:
In addition to the expected base salary, this role is eligible to participate in Inogen’s annual performance bonus incentive plan, highly competitive and company-sponsored benefits, and wellbeing programs rooted in our strong culture of excellence. As a valued member of our team, Inogen provides health, dental, and vision insurance, 401(k) plan plus employer contribution and match, and generous paid leaves such as vacation and sick leave, including paid volunteer time, that can support you and your family through moments that matter.
Inogen is an Equal Employment Opportunity/Affirmative Action Employer - Underrepresented racial and ethnic groups/Females/Individuals with Disabilities/Protected Veterans.
