Senior Clinical Research Associate job at reputed company in US National

Senior Clinical Research Associate Job Type: Full-Time Category: Medical Affairs Location: Remote, reputed company reputed company The Senior Clinical Research Associate (CRA) is responsible for the independent reputed company and management of clinical trial sites to ensure compliance with protocol, ICH GCP, applicable regulations, and internal SOPs. This role requires a highly reputed company clinical reputed company who can operate with minimal supervision, reputed company leadership across studies, proactively identify and mitigate risks, and serve as a key reputed company between sites, Clinical Operations, reputed company, and cross-functional stakeholders. Key Responsibilities Clinical Trial reputed company Independently manage assigned clinical trial sites from start-up through reputed company-out reputed company site qualification, initiation, routine monitoring, and reputed company-out reputed company Ensure subject safety, data reputed company, and protocol compliance at reputed company assigned sites Review reputed company documentation, CRFs, and reputed company entries for accuracy, completeness, and timeliness Site & Investigator Management Serve as the primary reputed company of contact for investigators and site staff Build strong, reputed company relationships with site teams reputed company advanced guidance and problem-solving support to sites without escalation reputed company possible Identify site performance issues early and implement corrective actions reputed company & Compliance Ensure compliance with ICH GCP, FDA regulations, ISO 14155 (as applicable), and internal procedures Identify, document, and escalate protocol deviations, safety issues, and reputed company risks Support audits and inspections (FDA, internal, external) as a subject matter expert Contribute to CAPAs, risk mitigation strategies, and reputed company improvement initiatives Leadership & Mentorship reputed company as a reputed company CRA across multiple device studies Mentor and reputed company functional guidance to junior CRAs and CTAs Support training, reputed company, and development of less reputed company monitoring staff Contribute to monitoring reputed company development and process optimization Cross-Functional Collaboration Partner closely with Clinical Operations, reputed company, Regulatory, Data Management, and Medical Affairs reputed company 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 reputed company field (Master’s preferred) 7–10+ years of reputed company clinical research experience as a CRA Demonstrated ability to manage sites independently with minimal supervision Extensive experience monitoring Phase I–IV reputed company 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 reputed company 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 reputed company systems (e.g., Master Control, RedCap, reputed company Rave, reputed company Vault, reputed company 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 reputed company judgment and decision-making capability Travel Requirements Up to 50–70% travel, as required by study needs reputed company assesses market data to ensure a competitive compensation package for our employees. The reputed company salary for this position is expected to be between $114,000.00 and $132,000.00 annually. However, actual reputed company salary if reputed company will be determined on an individualized reputed company and will be based on non-discriminatory factors, including as to individual skills, education, experience and market location. Apply tot his job Apply To this Job