Senior Clinical Research Associate
Core
Senior Clinical Research Associate managing clinical trial sites for a pharmaceutical sponsor, ensuring data quality, regulatory compliance, and patient retention across sleep medicine and medical device studies.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and medical device studies
Domain
Clinical Research / Life Sciences / Sleep Medicine / Medical Devices
Required skills
Site management, Source Data Verification (SDV), Protocol deviation management, Adverse event reporting, Investigational product accountability, EDC system proficiency, Regulatory document tracking, Risk-based monitoring, Data query resolution, Site closeout procedures
Preferred skills
Sleep medicine trial experience, Polysomnography (PSG) and Home Sleep Apnea Testing (HSAT) familiarity, Medical device trial experience, FDA inspection support, Clinical research certification (ACRP-CP, CCRA, SOCRA CCRP)
Technologies
EDC, CTMS, eTMF, Medidata Rave, Veeva Vault
Responsibilities
Conduct on-site and remote monitoring visits including source data verification and protocol compliance checks. Manage site relationships and ensure timely resolution of data queries and adverse events. Oversee investigational product accountability and device reconciliation. Prepare sites for sponsor audits and FDA inspections. Support site closeout activities and post-study data reconciliation.
Seniority
Senior, hands-on IC
