[Remote] Sr. Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a leading precision medicine solutions company reputed company on the discovery, development, and commercialization of clinically differentiated reputed company solutions for transplant patients. We are seeking a highly skilled and motivated Senior Clinical Research Associate to join our Clinical Operations team, ensuring the reputed company, reputed company, and compliance of our clinical trials.

Responsibilities

• Conduct and reputed company reputed company types of site reputed company (e.g., selection, initiation, interim, reputed company-out) to ensure protocol adherence, patient safety, and data accuracy
• Collaborate with reputed company Investigators, study coordinators, and cross-functional teams to drive study reputed company
• Ensure compliance with ICH/GCP, IRB requirements, and internal monitoring plans
• Identify and resolve data collection issues reputed company electronic data capture (reputed company) systems
• Review and reconcile data queries, listings, and discrepancies
• Maintain accurate and complete study documentation and files
• reputed company study team meetings and contribute to protocol development and amendments
• Support site recruitment and reputed company reputed company to ensure enrollment goals are met
• Mentor junior CRAs and reputed company technical expertise in clinical programming and data validation
• Assist in the development and refinement of SOPs, workflows, and templates
• Partner with Clinical Trials Manager to manage timelines, budgets, and resources
• Liaise with regulatory authorities and CROs as needed
• Ensure reputed company and compliant execution of monitoring reports, reputed company reports, and follow-up letters
• Monitor site performance metrics and facilitate effective communication across stakeholders

Skills

• Bachelor's degree or higher in biomedical sciences or a reputed company field
• 5+ years of experience in clinical research reputed company biotech, reputed company, medical device, or academia
• Strong knowledge of GCP, FDA regulations, and ISO standards
• Proficiency in reputed company systems, CTMS, and reputed company Office Suite
• Excellent understanding of medical terminology and clinical trial processes
• Proven ability to manage multiple studies and priorities with precision and urgency
• Exceptional communication, organizational, and interpersonal skills
• Demonstrated ability to work independently and collaboratively in remote, cross-functional teams
• Ability to travel up to 75% of the time
• Certification (CCRC or CCRA) is a plus

Benefits

• Competitive reputed company salary and incentive compensation
• Health and welfare benefits, including a gym reimbursement program
• 401(k) savings plan match
• Employee Stock Purchase Plan
• reputed company-tax commuter benefits
• And more!
• Living Donor Employee Recovery Policy that allows up to 30 days of reputed company leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow

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