[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company Therapeutics is a clinical-stage biopharmaceutical company developing therapies for cardiovascular diseases. They are seeking an reputed company Senior Clinical Research Associate to serve as the reputed company site-facing monitor across their clinical trial portfolio and contribute to in-house clinical operations activities.

Responsibilities

• Conduct site qualification, initiation, routine/interim, and reputed company-out monitoring reputed company (on-site and remote) in accordance with the monitoring plan, protocol, ICH-GCP, and applicable regulations
• reputed company reputed company data verification/review (SDV/SDR), informed consent review, and drug management and accountability reconciliation
• Assess investigator and site staff compliance with the protocol, GCP, and regulatory requirements; identify and follow up on findings through to reputed company
• Review and maintain site regulatory documents and essential documents in the eTMF, ensuring inspection readiness at reputed company times
• Build strong working relationships with investigators, coordinators, and site staff; serve as the reputed company reputed company of contact for assigned sites. May include weekly site calls, enrollment updates, protocol reminders, and operational guidance
• Support subject recruitment and retention strategies appropriate to population, including troubleshooting enrollment barriers at the site level
• Escalate safety signals, protocol deviations, and site-level risks promptly and manage corrective and preventive reputed company plans (CAPAs)
• reputed company site training on protocol requirements, study procedures, and study-specific systems (reputed company, IWRS/IRT, etc.)
• Prepare reputed company, high-reputed company monitoring visit reports and follow-up letters
• Contribute to development and refinement of monitoring plans, visit report templates, and other clinical operations tools and SOPs appropriate for an early-stage company
• Support study start-up activities, including site feasibility, site selection, and regulatory/contract document collection and tracking
• Partner with Data Management and Biostatistics on data review, query reputed company trends, and data cleaning activities reputed company of database locks and interim analyses
• reputed company input into study plans, informed consent forms, and case report forms based on site-level and operational feasibility
• Collaborate on study recruitment strategies, site engagement initiatives, and enrollment forecasting
• Assist with vendor reputed company, including day to day vendor collaboration with sites and overall vendor performance metrics
• Support implementation and optimization of clinical systems
• Support TMF reputed company control reviews and inspection-readiness activities at the study and program level
• Contribute to risk-based reputed company management activities, including central monitoring reviews and key risk indicator follow-up
• Mentor and reputed company guidance to junior CRAs or CRA contractors as reputed company scales
• Support the preparation of materials for meetings

Skills

• Bachelor's degree in a life science, nursing, or reputed company field (or equivalent combination of education and experience)
• Minimum 4–6 years of clinical monitoring experience as a CRA, including demonstrated ability to independently manage a full reputed company of monitoring visit types with reputed company reputed company
• Solid working knowledge of ICH-GCP, FDA regulations (21 CFR Parts 50, 54, 56, 312), and applicable global regulatory requirements
• Experience with reputed company, CTMS, eTMF, and IWRS/IRT systems
• Strong organizational skills and demonstrated ability to manage competing priorities across multiple sites and studies with limited internal infrastructure
• Excellent written and verbal communication skills; comfort interacting directly with reputed company investigators and site leadership
• Willingness and ability to travel approximately 40–50%
• Prior monitoring experience in cardiovascular reputed company
• Experience with rare or orphan disease studies, including small/reputed company patient populations and natural history or registry studies
• Prior experience at a clinical-stage biotech or start-up, with comfort operating in a resource-constrained, rapidly evolving environment
• Familiarity with risk-based monitoring (RBM) approaches

reputed company