Summary

The Baylor College of Medicine Clinical Research Team works in collaboration with Texas Children's Hospital Pavilion for Women. Our main focus is on Maternal and Fetal clinical and sponsored trials. We are seeking a full-time Manager of Clinical Research to contribute to the strategic direction of research activities for the OB/GYN Research Department to ensure clinical research projects are in compliance with GCP, ICH, FDA, and institutional guidelines and have met all required objectives and goals. This person will manage and be responsible for coordinating the day-to-day activities of research staff at Texas Children's Pavilion for Women and Harris Health Ben Taub Hospital to ensure accurate data collection, regulatory compliance, organization, and safety of all research participants in more than 4 research studies or clinical trials.

Job Duties

• Ensures research strategies and procedures are compliant with federal (FDA, NIH) and local IRB regulations, grant requirements, and BCM and TCH organizational guidelines.
• Develops and administers research plans, policies, and procedures for multi-disciplinary research projects, frequently coordinating with physicians and research staff in other departments.
• Supervises clinical research and administrative staff; provides training and guidance on regulations and best practices.
• May prepare research presentations and draft manuscripts.
• Monitors and leads research project expenditures; make recommendations pertaining to work operations and priorities to meet research objectives.
• Evaluates results to ensure alignment with established research objectives and project timelines.
• Prepares internal and external communications to federal oversight agencies and regulatory bodies including oversight of all FDA reporting requirements for sponsor-investigator trials.
• Schedules, coordinates, and participates in the internal feasibility meeting, pre-site visit and site initiation visits.
• Supports investigators and clinical research staff with reporting, study monitoring, and site visits.
• Develops, implements, and monitors research protocols, procedures, and processes.
• Oversees data collection and documentation activities; queries databases and prepares reports; manages compliance documents.
• Implements process improvements to maximize productivity.
• Ensures financial management and accountability of research projects, including budget administration, performing cost assessments, monitoring financial transactions, and financial reporting.
• Makes strategic recommendations
• Communicates and conducts regular briefings with leadership regarding research operations and strategic initiatives.
• Manages research staff, to include defining work responsibilities and prioritization, setting performance development plans and goals, and conducting annual performance evaluations.
• Coordinates monitoring, audits and follow up of all research activities

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience. 

Preferred Qualifications

• Effective communication skills, both orally and in writing.
• Experience with computer spreadsheets and database management.
• Broad knowledge in leading and managing research processes, projects and tactics for a multi-disciplinary team.
• Interpersonal skills necessary to supervise research staff.