Senior Clinical Research Associate at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Clinical Research Associate in the United States.

This role offers the opportunity to take a leadership position in clinical trial monitoring, providing independent oversight of multiple sites and ensuring high-quality study execution. You will serve as a key liaison between clinical sites and cross-functional teams, proactively managing risks and ensuring compliance with regulatory standards. The position allows you to mentor junior staff, contribute to process improvements, and participate in complex, multi-phase trials, including medical device studies. With significant autonomy and responsibility, this role is ideal for experienced professionals who thrive in dynamic, fast-paced environments and want to impact clinical research outcomes directly. The work requires travel to sites, offering exposure to a variety of study environments and operational challenges. You will play a critical role in maintaining patient safety, data integrity, and protocol adherence across all assigned studies.

• Independently manage clinical trial sites from start-up through close-out, ensuring compliance with protocol, ICH GCP, FDA regulations, and ISO 14155 standards.

• Conduct site qualification, initiation, routine monitoring, and close-out visits while reviewing source documents, CRFs, and EDC entries for accuracy and completeness.

• Serve as the primary point of contact for investigators and site staff, building collaborative relationships and providing advanced problem-solving support.

• Identify and address site performance issues early, implementing corrective actions and contributing to CAPAs and risk mitigation strategies.

• Act as a Lead CRA or Senior CRA across multiple studies, mentoring junior CRAs and supporting their onboarding and development.

• Collaborate closely with Clinical Operations, Quality, Regulatory, Data Management, and Medical Affairs teams to ensure operational excellence.

• Support audits and inspections, providing subject matter expertise and ensuring adherence to internal and regulatory standards.

Requirements:

• Bachelor’s degree in life sciences, nursing, or related field (Master’s preferred).

• 7–10+ years of progressive clinical research experience as a CRA, with independent site management.

• Extensive experience monitoring Phase I–IV clinical trials and/or medical device studies.

• Strong working knowledge of ICH GCP, FDA regulations, and ISO 14155 standards.

• Proven experience supporting audits and regulatory inspections.

• Excellent critical thinking, risk-based monitoring, and communication skills.

• Ability to manage multiple studies, prioritize tasks, and operate autonomously in a fast-paced environment.

• Preferred: Lead CRA experience, mentoring of junior staff, familiarity with EDC systems (e.g., Medidata Rave, Veeva Vault), and experience in startup or high-growth settings.

Benefits:

• Competitive base salary ranging from $114,000 to $132,000, based on experience and location.

• Eligibility for annual performance bonus incentives.

• Comprehensive health, dental, and vision insurance coverage.

• 401(k) plan with employer contribution and match.

• Paid vacation, sick leave, and volunteer time.

• Opportunities for professional development and mentorship within a dynamic clinical research environment.

• Exposure to complex, multi-site clinical trials and the chance to influence operational processes and study outcomes.