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Job Summary
We are seeking a dynamic and highly organized Clinical Research Operations Manager to lead and oversee the execution of clinical trials within our research programs. This pivotal role involves managing multidisciplinary teams, ensuring compliance with regulatory standards, and maintaining the highest quality of data collection and documentation. The ideal candidate will be passionate about advancing healthcare through meticulous research management, possess strong leadership skills, and have extensive experience in clinical trial operations. Join us to drive innovative research projects that make a meaningful impact on patient care and medical advancements.
Responsibilities
- Lead and supervise clinical research teams, including coordinators, nurses, and laboratory staff, to ensure smooth trial operations and adherence to project timelines.
- Oversee all aspects of clinical trial management, including protocol development, patient recruitment, informed consent processes, and patient monitoring.
- Ensure compliance with FDA regulations, ICH GCP guidelines, HIPAA standards, and other relevant healthcare regulations to uphold ethical standards and data integrity.
- Review and approve study documentation such as case report forms (CRFs), consent forms, and regulatory submissions to guarantee accuracy and completeness.
- Coordinate with clinical laboratories for blood sampling, phlebotomy procedures, vital signs collection, and analysis to support trial requirements.
- Utilize EMR (Electronic Medical Records) systems for data entry, management, and reporting while maintaining strict confidentiality.
- Monitor trial progress through regular audits, quality assurance checks against clinical quality standards, and adherence to research ethical guidelines.
- Manage project timelines, budgets, resource allocation, and risk mitigation strategies to ensure successful trial completion.
- Collaborate with statisticians using statistical software for data analysis and interpretation of research findings.
- Maintain comprehensive records of all research activities in compliance with Good Clinical Practice (GCP) standards.
Skills
BILINGUAL
- Proven supervising experience in clinical research or healthcare settings with strong leadership capabilities.
- Extensive knowledge of medical terminology, clinical development processes, and research methods.
- Proficiency in data management systems, CDISC standards (Clinical Data Interchange Standards Consortium), and EMR platforms.
- Familiarity with FDA regulations, ICH GCP guidelines, HIPAA compliance requirements, and clinical ethical guidelines.
- Experience with clinical trials management software.
- Strong documentation review skills ensuring accuracy in regulatory submissions and study records.
- Excellent project management skills with the ability to coordinate multiple tasks simultaneously.
- Knowledge of blood sampling techniques such as phlebotomy and vital signs measurement.
- Certification in ICH GCP from a recognized issuer (e.g., CA or equivalent) is highly desirable.
- Effective communication skills for liaising with regulatory bodies, healthcare professionals, and research teams.
- Attention to detail combined with analytical skills necessary for high-quality data collection and reporting.
Join us as a Clinical Research Operations Manager to lead groundbreaking studies that shape the future of healthcare. Your expertise will ensure our research projects meet the highest standards of quality while fostering innovation in patient-centered care. This is a paid position committed to advancing scientific discovery within a collaborative environment dedicated to excellence.
Pay: $62,000.00 - $80,000.00 per year
Work Location: In person
