Operation manager for clinical research

Overview
We are seeking an experienced and detail-oriented Operation Manager for Clinical Research to oversee and coordinate clinical trial activities within our organization. The ideal candidate will possess strong leadership skills, extensive knowledge of clinical trials management, and a thorough understanding of regulatory compliance, including FDA regulations and ICH GCP standards. This role offers an opportunity to lead innovative research projects, ensure adherence to strict protocols, and contribute significantly to the advancement of medical science. The position requires a proactive professional with proven supervising experience and expertise in clinical research operations.

Duties

• Lead and supervise multidisciplinary clinical research teams, ensuring efficient execution of clinical trials from initiation to completion
• Manage all aspects of clinical trials management, including protocol development, documentation review, patient monitoring, and data collection
• Ensure compliance with FDA regulations, ICH GCP guidelines, HIPAA standards, and other relevant regulatory requirements
• Oversee clinical laboratory processes such as blood sampling, vital signs measurement, and patient assessments
• Review and maintain accurate documentation related to trial activities, adverse events, and regulatory submissions
• Coordinate with research staff to ensure proper data management using EMR systems and adherence to CDISC standards
• Monitor patient safety and progress throughout the trial duration, including patient recruitment, retention, and follow-up procedures
• Facilitate training sessions on research protocols, compliance management, and use of statistical software for data analysis
• Collaborate with external partners such as laboratories or regulatory agencies to ensure smooth trial operations
• Maintain up-to-date knowledge of clinical development trends, emerging regulations, and advancements in research methodologies

Skills

• Proven supervising experience in a clinical research or healthcare setting
• Extensive knowledge of clinical trials management, including protocol review and compliance oversight
• Strong understanding of medical terminology, blood sampling techniques (phlebotomy), vital signs assessment, and patient monitoring procedures
• Proficiency with statistical software and data management tools specific to clinical research environments
• Familiarity with FDA regulations, ICH GCP guidelines, HIPAA compliance standards, and CDISC data standards
• Experience with EMR systems and clinical laboratory processes
• Background in nursing or clinical laboratory work is highly desirable
• Excellent documentation review skills coupled with meticulous attention to detail
• Ability to analyze complex data sets for research purposes and ensure accuracy in reporting
• Effective communication skills for training staff and collaborating across departments
• Any valid issuer certification for CA related to clinical research or healthcare is preferred

This role is integral to advancing our organization's mission in medical innovation through rigorous oversight of clinical trials. We seek dedicated professionals committed to maintaining the highest standards of quality and compliance in all research activities.

Job Types: Full-time, Part-time

Pay: From $50,000.00 per year

Expected hours: 20 – 40 per week

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Professional development assistance
• Retirement plan

Work Location: Hybrid remote in Houston, TX 77089