Summary

The Office of Surgical Research (OSR) within the Michael E. DeBakey Department of Surgery is seeking a Manager, Clinical Research to supervise and oversee clinical research and financial activities of clinical trials. The Manager, Clinical Research will be responsible for supervising daily activities of clinical research staff supporting clinical research protocols; ensuring accurate data collection, documentation, organization, and safety of research participants; and developing clinical trials budgets. The Manager, Clinical Research will support the Sr. Associate Administrator on various administrative, operational, and financial duties required to reach departmental goals and objectives.

Job Duties

• Supports the Sr. Associate Administrator overseeing the clinical research activities in the Michael E. DeBakey Department of Surgery, including recruitment, supervision, training, scheduling, and daily operations of clinical research staff.
• Manages strategy, planning, development, and clinical trial activities across all stages of study lifecycle including protocol design and development, site initiation, study execution, regulatory oversight, and closeout processes for clinical studies and trials in the Department.
• Maintains knowledge of institutional, state, federal and international guidelines that govern clinical research. Educates new Faculty and clinical research staff generally during the on-boarding and early establishment processes. Communicates changes on regulations and guidelines to staff.
• Responsible for communicating the Institution policies and procedures to research support staff and Principal Investigators.
• Provides guidance and timely responses to requests from faculty seeking to participate in industry and federally funded clinical studies through coordination of planning/feasibility meetings, coverage analysis, budget development, internal compliance approval oversight, and contract negotiations.
• Supports the Sr. Associate Administrator overseeing payroll and salary administration in the clinical research area and assists with the implementation of organizational and operational decisions.
• Directly supervises a growing team of clinical research personnel including all levels of Research Coordinators and research staff.
• Drafts HR position descriptions and recruits additional research staff personnel for the Office of Surgical Research.
• Ensures that all internal personnel activities meet College and organizational objectives in training, recruitment, equal pay, equal opportunity, transfer, and promotion.
• Establishes and implements quality assurance and quality control measures/oversight to ensure adherence to College’s policies and regulatory standards.
• Maintains up-to-date and accurate records and reports of clinical research, and monitors research metrics as requested.
• Contributes to quarterly/biannual/annual metrics reports.
• Performs other job-related duties as assigned.

Minimum Qualifications

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

Preferred Qualifications

• Master's degree.
• Four years of clinical research experience.
• Knowledge regarding global requirements regarding Clinical Trials requirements and negotiations.
• Strong negotiation, planning, perform strategy analysis, mentoring, monitoring, scheduling, diplomacy, critiquing, analysis, and problem-solving skills.
• Excellent written and verbal communication skills, to clearly and concisely present information.