Principal CRA
Posted Aug 24
Posted Aug 24
This is a fully remote position, open to applicants in Pennsylvania.
• Oversee site management functions, encompassing site selection, initiation, monitoring, and close-out visits.
• Act as the main point of contact for clinical sites, addressing inquiries and resolving any issues.
• Ensure the integrity of clinical data through source data verification, review of site records, and monitoring for protocol deviations.
• Mentor and support CRAs, fostering their professional growth and the consistent application of best practices.
• Collaborate with clinical project managers, data managers, and biostatisticians to successfully carry out clinical trials.
• Coordinate the delivery of clinical trial monitoring, troubleshoot issues, and enhance team capabilities.
• Bachelor's degree in a relevant scientific discipline or a healthcare-related field.
• Significant experience as a Clinical Research Associate in the pharmaceutical, biotech, or CRO sectors, with a proven history of managing complex clinical trials.
• Comprehensive understanding of ICH-GCP guidelines, regulatory standards, and clinical trial processes.
• Strong leadership and mentoring abilities, capable of effectively managing and motivating CRAs and site personnel.
• Excellent communication, organizational, and problem-solving skills, with a proactive approach to site performance management and issue resolution.
• Willingness to travel as necessary (approximately 60%).
• Legal authorization to work in the country where the position is based.
• Competitive base salary along with performance-related incentives.
• Health and wellness programs, including medical, dental, and vision coverage where applicable.
• Retirement and pension schemes.
• Life insurance and disability coverage.
• Employee assistance programs and wellbeing resources.
• Opportunities for learning and development through structured training and career pathways.
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